John Oliver's take on "Unregulated" Dietary Supplements

Another salvo in the War on Vitamins and Dietary Supplements:

John Oliver was funny, but not remotely fair or accurate. Some of the more grievous false examples (in my opinion):

• He assumed no new laws or regulations have been implemented since DSHEA (the Dietary Supplement Health & Education Act of 1994)
o Untrue, and some have been championed by industry; some examples:
 The 2002 Anti-Bioterrorism law's food safety regulations
 The implementation of mandatory Good Manufacturing Practices regulations and increasing numbers of FDA audits over the past 4 years
 Bans on steroids and their precursors
 A mandatory Adverse Event Reporting law
 The more recent Food Safety Law

• He showed old news reports speculating that the botanical ephedra killed 155 people, asserting that these deaths occurred because of DSHEA tying FDA’s hands
o FDA was admittedly unable to substantiate any deaths
o FDA was able to ban ephedra under DSHEA anyway based on a solely theoretical one death per year from billions of doses taken, despite two FDA expert panels unable to validate any deaths

• He claimed that FDA and FTC are powerless to act because of DSHEA, Hatch and Harkin
o The number of enforcements have been rapidly increasing
 Warning letters, recalls, even seizures
o The number of FDA inspections has been rapidly increasing

• He showed how many citizens supported DSHEA in 1993-1994, but asserted that they were misled by industry champions Senators Hatch and Harkin, who received donations from the then relatively tiny $2 billion industry
o He implied that Hatch and Harkin did it solely for the money
o He implied that Hatch and Harkin still block all regulation; see above for contrary examples
 some of the more recent laws were supported by industry and even sponsored by Hatch and/or Harkin)

• He assumed that dietary supplements are largely unregulated because of not enough regulation, rather than their relatively good safety record versus drugs or even other foods
o He promoted pre-market approval of products and claims, similar to a failed Canadian strategy that cut product selection without enhancing safety
o He cited DNA testing of botanicals failing 1/3 of products tested, without mentioning that this is actually a proposed but not yet validated assay technology disputed by herbal authorities as far too premature to use as a standard

This does not address his criticisms of Dr. Oz, who can defend himself.

Link to show:
http://theweek.com/speedreads/index/263585/speedreads-john-oliver-steps-on-dr-oz-to-savagely-trample-the-dietary-supplement-industry

How Dietary Supplements are Regulated

How Dietary Supplements are Regulated

A Timeline of Dietary Supplement Regulation since 1994

1994 The Dietary Supplement Health and Education Act (DSHEA)

• Continues to define dietary supplements as a special Food category; not as food additives 
• Sets new safety standards and FDA authorization to prevent imminent hazards
• Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the FDA
• GMPs were fully implemented between June 2008 and June 2010
• Regulates labels
• All claims must be truthful and not misleading; documentation must be maintained
• All ingredients must be declared on product labels
• Approves pre-existing dietary ingredients already on the market as of October 15, 1994
• Common vitamins, minerals, herbs
• “Grandfathering” was twice applied to pharmaceuticals already on the market:
• The 1938 Food, Drug and Cosmetic Act
• The 1962 Kefauver-Harris Amendment
• This is analogous to pharmaceuticals where all drugs entering the market after 1938 and then after October 10, 1962 require an FDA submission/approval process
• Requires pre-market submission to FDA of all New Dietary Ingredients (NDIs), not products
• The agency questions or rejects the majority of submissions

 1997 The Food and Drug Administration Modernization Act (FDAMA)

•  Provides for health and nutrient content claims based on an authoritative statement by a scientific body of the U.S. government (i.e. NIH) or the National Academy of Sciences
• Such claims may be used only after review of a health claim notification by FDA

2002 The Public Health Security and Bioterrorism Preparedness and Response Act

• All food manufacturers, including dietary supplement manufacturers, are required to be registered with the government and give advance notification of raw materials imports

 2003 The FDA Consumer Health Information for Better Nutrition Initiative

• Provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation

2004 The Anabolic Steroid Control Act amendment

• Bans steroid precursors sold as dietary supplements
• The FDA and DEA have authority to take action against adulterated products

2004 The Food Allergen Labeling and Consumer Protection Act

• Requires label disclosure of the 8 major allergens that cause 90% of all food allergies

 2006 The Dietary Supplement and Nonprescription Drug Consumer Protection Act

•  Requires record-keeping of all adverse events (AERs) and reporting of all serious AERs to FDA; for both dietary supplements and OTC drugs

 2007 Food and Drug Administration Amendments Act

• Prohibits interstate commerce of any food, including dietary supplements, containing drugs or medical biologic products approved by FDA as such or clinically investigated as drugs/biologics

2010 The annual report of the American Association of Poison Control Centers

•  Published in the journal Clinical Toxicology
• Reports zero reports of accidental deaths from dietary supplements

2010 Full implementation of mandatory federal cGMPs was completed in June

• All manufacturers & suppliers are now bound by FDA standards of safety and documentation

2010 The FDA Food Safety Modernization Act

• Includes enhanced mandatory recall authority for most foods, including dietary supplements
• Expanded facility registration and HACCP (safety handling) rules
• Requires FDA to issue guidance on New Dietary Ingredients (NDIs), per DSHEA

2011 The FDA released a new Guidance on its enforcement of NDI regulations

• Requires approval of NDIs by the FDA, not just pre-market notification to the agency
• Redefines NDIs as all products containing an NDI ingredient, not just the ingredient itself
• Expands the definition of NDI to include new ingredient processing techniques
• Would encompass tens of thousands of products versus dozens of ingredients earlier projected (1997)

2012 Due to objections from Senate leaders who had co-sponsored DSHEA, FDA notifies Senators Hatch and Harkin that its NDI guidance will be revised & reissued

 

Sufficient Regulation of Supplements

Critics claim that dietary supplements are under-regulated, which is arguably inaccurate. Critics suggest that the FDA should have the power to ban synthetic analogues of botanical ingredients even when there is no credible safety issue, a major expansion of government authority. There are disturbing attempts to expand the role of unelected government bureaucrats as censors of nature-identical ingredients, even those with a history of safe use.

The FDA recently reinterpreted a 1994 law requiring pre-market notification of New Dietary Ingredients (NDI) unknown to the marketplace or our food supply. The law grants it authority over novel ingredients, not products, by requiring notification, rather than pre-approval. Now the agency is promoting a radical vision by prematurely enforcing its widely criticized Revised NDI Guidance that violates the letter and spirit of the law. FDA asserts the unilateral power to change from requiring pre-market notification of a new ingredient to a de facto registration giving it virtual veto power over all products containing that ingredient. Under its new interpretation, any change of processing or source (i.e. synthetic botanical) gives the FDA power to reject an ingredient even when indistinguishable from one in the food chain.

FDA lacks not only legal authority, but resources to screen thousands of products explicitly regulated as a food category with a presumption of safety. The FDA rejects most pre-market notifications of new ingredients; slowing introduction of new dietary supplements to the marketplace.

Industry critics ignore how dietary supplement regulation has evolved. Mandatory Good Manufacturing Practices (GMPs) are being vigorously audited/enforced by FDA, requiring identity, potency, and safety testing plus rigorous procedure documentation. All serious adverse events must be reported to the FDA within 15 business days. GMP audits and NDI notifications represent pre-market monitoring; AERs post-market surveillance. The Food Safety Bill enhanced FDA’s recall authority. This regulatory regime is so successful that for years there have been no deaths from dietary supplements reported to Poison Control Centers. Current laws work. We don’t need a virtual government takeover of the dietary supplement industry under the pretense of safety.

NYT Hatchet Job on Senator Hatch

Re: “Support Is Mutual for Senator and Utah Industry” (The Champions, June 20, New York Times)

The article presented an inaccurate impression regarding the nutritional supplement industry. Despite heavy costs, manufacturers supported federal regulations creating more rules/enforcement to enhance accountability and public safety. A 1994 law (DSHEA) regulating the dietary supplement industry allows only FDA-approved ingredients and scientifically-supported claims relating to healthy body structures and functions; besides FDA-approved claims.

Additional regulations supported by industry: DSHEA’s mandatory Good Manufacturing Practices (GMP) requiring safety and identity testing, steroids and their precursors are banned; manufacturers must promptly disclose adverse events requiring medical attention; mandatory safety recall authority.  

Senator McCain’s proposed dietary supplement regulation would have subjected each new product introduction to prior FDA approval, expanding the federal bureaucracy with a government takeover of the industry. Importing this Canadian-style regulatory scheme would duplicate that system’s failures: half as many products available; some considered safe in the USA are banned; long waits for variations of existing products; higher prices.

Fortunately, the American people rejected giving government bureaucrats veto authority over all new nutritional products, which already must use preapproved ingredients. We view this as anti-capitalism and un-American.

Neil E. Levin, CCN, DANLA

Clinical Nutritionist

HonestNutrition.com

re:

http://www.nytimes.com/2011/06/21/us/politics/21hatch.html?_r=2&pagewanted=all

Dietary Supplements are now Safely Regulated

TIMELINE:

1994 The Dietary Supplement Health and Education Act (DSHEA)


• Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the FDA


     o GMPs were fully implemented between June 2008 and June 2010


• Continues to define dietary supplements as Food


• Regulates labels

     o All claims must be truthful and not misleading

     o All ingredients must be on the labels

     o Documentation to prove claims must be maintained

• Approves pre-existing dietary ingredients already on the market as of October 15, 1994

     o Common vitamins, minerals, herbs

     o “Grandfathering” was twice applied to pharmaceuticals already on the market:

     o  The 1938 Food, Drug and Cosmetic Act & 1962 Kefauver-Harris Amendments

• Requires pre-market submission to the FDA of all New Dietary Ingredients marketed after October 15, 1994

     o The agency questions the majority of submissions

     o The agency has the power to reject applications; and has done so

     o This is analogous to pharmaceuticals where all drugs entering the market after October 10, 1962 require an FDA submission/approval process


1997 Food and Drug Administration Modernization Act (FDAMA)

• Provides for health claims based on an authoritative statement by a scientific body of the U.S. government or the National Academy of Sciences

• Such claims may be used only after submission of a health claim notification to FDA



2002 The Public Health Security and Bioterrorism Preparedness and Response Act

• All food manufacturers, including dietary supplement manufacturers, are required to be registered with the government and give advance notification of raw materials imports



2003 The FDA Consumer Health Information for Better Nutrition Initiative

• Provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation

     o Such health claims must be qualified to assure accuracy and non-misleading presentation to consumers



2004 The Anabolic Steroid Control Act amendment

• Bans steroid precursors sold as dietary supplements

     o The FDA and DEA have authority to take action against adulterated products



2006 The Dietary Supplement and Nonprescription Drug Consumer Protection Act

• Requires reporting of all serious adverse events (AERs) for both dietary supplements and OTC drugs


The Food Allergen Labeling and Consumer Protection Act


• Requires label disclosure of the 8 major allergens that cause 90% of all food allergies



2010 The most recent annual report of the American Association of Poison Control Centers

• Published in the journal Clinical Toxicology

• Reports zero reports of accidental deaths from dietary supplements



     Full implementation of mandatory federal cGMPs was completed in June

• All manufacturers & suppliers are now bound by FDA standards of safety and documentation



     The Dietary Supplement Full Implementation and Enforcement Act

• Introduced in Congress to increase funding for FDA enforcement of dietary supplement laws



     The Food Safety bill

• Includes enhanced mandatory recall authority for all foods, including dietary supplements

• Expected to pass Congress soon

Vitamins Are FDA-Regulated

Contrary to popular myth and The Healthy Skeptic (LA Times 3/1/10), the federal FDA (Food and Drug Administration) already regulates dietary supplements such as vitamins, minerals and herbs. These are NOT “unregulated” products. What actually makes critics’ teeth grind is the fact that vitamin formulas do not need specific pre-approval from the federal regulators, which is the true endgame of many skeptics. But all ingredients used in nutritional supplements before mid-October of 1994 are already pre-approved by the FDA under an often-misrepresented law called DSHEA, which also requires all new dietary ingredients to be submitted to the FDA for pre-market review before a product is sold. This gives the agency a chance to review the required submission of safety and efficacy data before any new ingredient can be sold, and the power to veto its introduction.

Dietary supplement manufacturers are already required to submit label claims along with scientific documentation to the FDA, but are paradoxically required to use a label disclaimer that the agency has not evaluated the formula. Vitamin makers are already registered with the government, are already prohibited from making medical/drug claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. A recent adverse event reporting law promptly lets the FDA know of virtually any problem requiring medical attention in order to trigger recalls and new label warnings. Under DSHEA, the FDA can regulate the manufacture of all dietary supplements, an oversight that was dramatically improved over the past 3 years with the rollout of mandatory Good Manufacturing Practices. Obviously, this is not an “unregulated” industry, even if enforcement can be improved in some areas.

Advocates of pre-approval of dietary supplement formulas want to import a highly flawed and controversial Canadian health care program in a misguided effort to give our own unelected government bureaucrats absolute power over already-regulated vitamin products. Many Canadians now cross the border to buy American supplements because their own government arbitrarily delays entry of new products for years at a time, miserly approving only 42% of products that have been submitted with all of the required safety and efficacy documentation. This is not a free market model, does not work well, and is not worth copying.

A permanent government takeover will strangle a preventive health industry that, in America’s free market, has added jobs and exports during our recent recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding; and probably decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. There is a complex regulatory structure for vitamins and other dietary supplements in the U.S. that is working quite well; there were ZERO deaths officially reported from these products last year even though about 2/3 of Americans use them. Claims that “vitamins are unregulated” are woefully inaccurate and should not be published by news outlets with competent fact checkers.

http://www.latimes.com/features/health/la-he-0301-skeptic-20100301,0,2486837.story

My response to Bill O’Reilly’s program “Suzanne Somers' 'No Spin' on Vitamins”

,On Friday, February 19, 2010, Bill O’Reilly discussed recent legislation introduced by Arizona Senator John McCain (the Dietary Supplement Safety Act; S.3002) to impose new regulations on dietary supplements (vitamins, etc.) with Suzanne Somers. He made several points that are quite reasonable: that there should be warnings on labels, that we should know what is in the products, that manufacturers should be registered with the FDA, that ingredients should be disclosed, and that the FDA should have recall authority. I heartily agree with these common sense statements but need to point out that these elements are already mandated by current federal regulations that simply may be inadequately enforced. As in other fields, a few shady operators ignore laws when profits can be made by cheating. The answer to the occasional scofflaw is strict enforcement of existing law; without enforcement, both current and new laws would be equally worthless. But Mr. McCain’s proposed new law will severely decimate law-abiding companies in a misguided effort to import an unpopular regulatory scheme from Canada that gives unelected government bureaucrats absolute power over already-regulated vitamin products. Canadians now cross the border to buy American vitamins because their own government arbitrarily delays entry of new products for years at a time, miserly approving only 42% of products that have been submitted with all the required safety and efficacy documentation. Current laws can accomplish Mr. O’Reilly’s goals, if they are enforced. Dietary supplement manufacturers are already registered with the government, are already required to submit label claims to the FDA, are already prohibited from making medical claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. Ingredients that have been on the market for many years are already pre-approved by the FDA and all new ingredients must be specially pre-approved before going to market. All mislabeled products are considered adulterated and subject to mandatory recall. A recent adverse event reporting law promptly lets the FDA know of virtually any problem requiring medical attention in order to trigger recalls and new label warnings, This does not sound like an unregulated industry, even if enforcement can be improved in some areas. What we don’t want is the FDA, an agency that is cozy with pharmaceutical interests, to have complete power over every new vitamin formula that is merely a variation of already-approved ingredients. That kind of permanent government takeover will strangle an important health industry that in a free market added jobs and exports during the recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding and may have actually decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. Understand and enforce the current laws before proposing a virtual federal takeover of an industry that is law-abiding, has welcomed recent regulations that have empowered federal authority over it, and would suffer great harm from a huge increase in unnecessary government interference. Think about it: If you were driving on the highway at 55 miles per hour and occasionally some jerk speeds by at 90, would dropping the speed limit to 45 correct the problem? Of course not. It obviously makes more sense to station additional cops along that stretch of highway to enforce current traffic laws than to collectively punish all drivers. Why is enforcement of vitamin laws any different? Target the outlaws, not the innocent! Neil E. Levin, CCN, DANLA www.honestnutrition.com

Boston Globe wrong on Vitamins, Supplements

Dietary Supplements Are Regulated In its Nov. 2 editorial, the Globe complained that the FDA is “powerless” to police dietary supplements and called for a repeal of the Dietary Supplement Health and Education Act of 1994. Health and Education Act of 1994. I suggest that the editors read the law and see what it is that they would lose by doing so. Mandatory Good Manufacturing Practices (GMP) were authorized by this law. GMPs control the manufacturing of all supplements, requiring quality controls, identity and safety testing. Federal GMPs are currently being implemented. No one in their right mind wants this to go away right when it is just getting started. Federal pre-approval of all new dietary ingredients (NDIs) is also required by DSHEA. Isn’t that close to what the editors suggest when they want pre-market approval of all new supplements? Adulterated products are already banned by this law. And steroids and steroid precursors are specifically banned under another more recent law that was supported by the dietary supplement industry. DSHEA bans misbranded products, such as those containing hidden drugs, and offers them absolutely no protection. In fact, the misbranded products that the editors complained about are actually defined as unlabeled drugs by the FDA, not as dietary supplements, so technically DSHEA does not even apply to them. Let’s leave out the evildoers who deliberately hide illegal drugs in bottles misbranded as dietary supplements. What does that leave us with? The vast majority of dietary supplement companies responsibly follow the law and do not have poor quality products. There are rarely cases of serious injuries or deaths from dietary supplements when you take away the products that are really illegal drugs made by outlaws who don’t care about the law or their own customers’ health. Responsible brands follow the new FDA dietary supplement GMPs, checking all ingredients for identity and purity and looking for contaminants and known adulterants. They truthfully declare all ingredients and correct dosages on the labels. They monitor product usage for adverse events and report serious ones to the FDA when they occur. They are not the criminals counterfeiting illegal drugs disguised as dietary supplements. What part of this cries out for such severe regulation that pre-market approval of new formulas is needed? How will new laws stop lawbreakers when their actions are already clearly illegal? Pre-market approval in Canada is a joke; many ingredients and formulas are not available there even though American citizens freely enjoy their use without serious issues. Some American manufacturers have already pulled out of the Canadian market, while others offer only small selections of their lines because of the bureaucratic hoop jumping required for government approval. If DSHEA is repealed, many safe legal products providing much-needed nutrients will disappear while the lawbreakers continue to do business, with a net harm to public health. http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/11/02/police_these_pills_and_powders/

Bias Against Natural Products

Bias Against Natural Products By Neil E. Levin, CCN, DANLA www.honestnutrition.com June 8, 2009 Once again, a widely distributed article has savagely attacked the safety and efficacy of natural products; including vitamins, minerals, and herbs. That this article may be more commentary than journalism is immediately revealed by the author inexplicably linking energy medicine (with admitted health benefits for patients) with a concocted image of “shooing evil spirits”, even when performed by technicians in a top trauma hospital. The ignorance of journalists and medical experts is exposed when they claim that natural products are intended as cures and treatments. These products are actually prohibited by law from claiming this; allowed only documented claims to support healthy body structures and functions. Ironically, this is the same law – the Dietary Supplement Health and Education Act, DSHEA - that is falsely mischaracterized as “deregulation” of the industry. In fact, this law prohibits new ingredients without FDA pre-approval; empowers the agency to regulate manufacturing, advertising, and label claims; prohibits unsafe, adulterated, and mislabeled products; and even allows banning a product based on only theoretical risks. A recent companion law requires all serious adverse events be reported to the FDA; generating far fewer reports than expected. The erroneous assumption that dietary supplements should be considered as potential treatments or cures has resulted in many negative reports. One problem is that some medical researchers, perhaps too used to drug studies using novel substances, sometimes base reports mainly on supplementation levels but fail to properly understand or explain other relevant variables such as dietary intake and relationships to other nutrients that affect body levels and functions of the targeted nutrient. The synergies of natural substances in the diet are complex and interactive, but many researchers design simplistic studies that generate incomplete or misleading data; often leading to dramatic conclusions that the pharmaceutical advertising-dependent press eats up. A press that fails to investigate and present all of the relevant facts and perspectives in a sensational negative report may be accused of laziness, if not bias. Rigorous studies refuting negative reports about the safety of vitamin E, beta-carotene, herbs, the use of supplements with cancer treatments, and drug-nutrient interactions have been noticeably absent from the same media that eagerly broadcasts reports attacking nature’s own nourishing substances. Sadly, there is no matching eagerness to set the record straight. Let’s keep this in perspective. We have all seen drugs pulled from the market because of unforeseen safety issues, medical schools and authors of articles published in peer-reviewed journals accused of being on the take from pharmaceutical companies, contaminated drugs as well as hundreds of thousands of deaths and millions of hospitalizations caused by pharmaceutical side effects each year. Foods cause hundreds of deaths and millions of illnesses annually. Compare this to dietary supplement safety, where proven deaths are extremely rare. Supplement users believe in the healing power of nature, at odds with the often unproven treatments of conventional medicine. The goal of Integrative Medicine is putting aside traditional institutional medical bias to allow science to dictate the comprehensive treatment of an individual patient, including quality of life issues. Many millions of Americans choose to use natural products in order to protect and improve their own health and vitality. Reasonable people will reject these sensational assaults on natural health (including dietary supplements), recognizing that conventional medicine sometimes fails without a little help from Mother Nature. References: Cancer patients may very well tolerate the use of certain dietary supplements http://caonline.amcancersoc.org/cgi/eletters/55/5/319#176 The truth about Vitamin E - Vitamin E is safer than implied http://www.bmj.com/cgi/eletters/330/7490/0-f#99008 Scientists to discuss benefits of vitamin E http://www.nutraingredients-usa.com/Research/Scientists-to-discuss-benefits-of-vitamin-E Vitamin review offers balanced perspective to recent negative findings http://www.worldhealth.net/news/vitamin_review_offers_balanced_perspecti Antioxidant supplements - myth or misunderstood? http://www.nutraingredients.com/Research/Antioxidant-supplements-myth-or-misunderstood Prominent Nutritionist Sets The Record Straight http://www.the-health-gazette.com/health-gazette-blog/nutrition/prominent-nutritionist-sets-the-record-straight FDA regulation of dietary supplements is sufficient http://www.journalgazette.net/apps/pbcs.dll/article?AID=/20090131/EDIT09/301319890/-1/AP05 Impact of antioxidant supplementation on chemotherapeutic efficacy: a systematic review of the evidence from randomized controlled trials. Block KI, Koch AC, Mead MN, Tothy PK, Newman RA, Gyllenhaal C. Cancer Treat Rev. 2007 Aug;33(5):407-18. Epub 2007 Mar 23. Review. PMID: 17367938 Antioxidants and other nutrients do not interfere with chemotherapy or radiation therapy and can increase kill and increase survival, part 1. Simone CB 2nd, Simone NL, Simone V, Simone CB. Altern Ther Health Med. 2007 Jan-Feb;13(1):22-8. Review. PMID: 17283738 Should patients undergoing chemotherapy and radiotherapy be prescribed antioxidants? Moss RW. Integr Cancer Ther. 2006 Mar;5(1):63-82. Review. PMID: 16484715 Multiple dietary antioxidants enhance the efficacy of standard and experimental cancer therapies and decrease their toxicity. Prasad KN. Integr Cancer Ther. 2004 Dec;3(4):310-22. Review. PMID: 15523102 The efficacy and safety of multivitamin and mineral supplement use to prevent cancer and chronic disease in adults: a systematic review for a National Institutes of Health state-of-the-science conference. Huang HY, Caballero B, Chang S, Alberg AJ, Semba RD, Schneyer CR, Wilson RF, Cheng TY, Vassy J, Prokopowicz G, Barnes GJ 2nd, Bass EB. Ann Intern Med. 2006 Sep 5;145(5):372-85. Epub 2006 Jul 31. Review. PMID: 16880453 Higher baseline serum concentrations of vitamin E are associated with lower total and cause-specific mortality in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Margaret E Wright, Karla A Lawson, Stephanie J Weinstein, Pirjo Pietinen, Philip R Taylor, Jarmo Virtamo and Demetrius Albanes. American Journal of Clinical Nutrition, Vol. 84, No. 5, 1200-1207, November 2006. (Researchers were from the Nutritional Epidemiology and the Genetic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, and the Cancer Prevention Fellowship Program, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, and the Department of Health Promotion and Chronic Disease Prevention, National Public Health Institute, Helsinki, Finland) Vitamins E and C are safe across a broad range of intakes. John N Hathcock, et al. REVIEW ARTICLE: American Journal of Clinical Nutrition, Vol. 81, No. 4, 736-745, April 2005. Potential for interactions between dietary supplements and prescription medications. Sood A, Sood R, Brinker FJ, Mann R, Loehrer LL, Wahner-Roedler DL; (Mayo Clinic). Am J Med. 2008 Mar;121(3):207-11. PMID: 18328304 Acute adverse effects of radiation therapy and local recurrence in relation to dietary and plasma beta carotene and alpha tocopherol in head and neck cancer patients. Meyer F, Bairati I, Jobin E, Gélinas M, Fortin A, Nabid A, Têtu B. Nutr Cancer. 2007;59(1):29-35. PMID: 17927499 Interaction between antioxidant vitamin supplementation and cigarette smoking during radiation therapy in relation to long-term effects on recurrence and mortality: a randomized trial among head and neck cancer patients. Meyer F, Bairati I, Fortin A, Gélinas M, Nabid A, Brochet F, Têtu B. Int J Cancer. 2008 Apr 1;122(7):1679-83. PMID: 18059031 The total antioxidant capacity of the diet is an independent predictor of plasma beta-carotene. Valtueña S, et al. Eur J Clin Nutr. 2007 Jan;61(1):69-76. Epub 2006 Jul 12. PMID: 16835597 [Supported by the European Community IST-2001–33204 'Healthy Market', the Italian Ministry of University and Research COFIN 2001 and the National Research Council CU01.00923.CT26 research projects.] No influence of beta carotene on oxidative DNA damage in male smokers. van Poppel G, Poulsen H, Loft S, Verhagen H. J Natl Cancer Inst. 1995 Feb 15;87(4):310-1. PMID: 7707423 Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. Hennekens CH, Buring JE, Manson JE, et al. N Engl J Med. 1996 May 2;334(18):1145-9. PMID: 8602179 Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study. J Natl Cancer Inst. 1999 Dec 15;91(24):2102-6. PMID: 10601381 The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994 Apr 14;330(15):1029-35. PMID: 8127329 Development of a comprehensive dietary antioxidant index and application to lung cancer risk in a cohort of male smokers. Wright ME, et al. Am J Epidemiol. 2004 Jul 1;160(1):68-76. PMID: 15229119 Plasma carotene and alpha-tocopherol in relation to 10-y all-cause and cause-specific mortality in European elderly: the Survey in Europe on Nutrition and the Elderly, a Concerted Action (SENECA). Buijsse B, et al. Am J Clin Nutr. 2005 Oct;82(4):879-86. PMID: 16210720 Effect of multivitamin and mineral supplementation on episodes of infection in nursing home residents: a randomized, placebo-controlled study. Liu BA, et al. J Am Geriatr Soc. 2007 Jan;55(1):35-42. Erratum in: J Am Geriatr Soc. 2007 Mar;55(3):478. PMID: 17233683 Nutrition intervention trials in Linxian, China: supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population. Blot WI, Li IY, Taylor PR, et al. J Natl Cancer Inst 1993:8ı:1483-92 Nutrition intervention trials in Linxian, China: multiple vitamin/mineral supplementation, cancer incidence, and disease-specific mortality among adults with esophageal dysplasia. Li JY, Taylor PR, et al. J Natl Cancer Inst. 1993 Sep 15;85(18):1492-8. PMID: 8360932 The Linxian trials: mortality rates by vitamin-mineral intervention group. Blot WI, et al. Am J Clin Nutr. 1995 Dec;62(6 Suppl):1424S-1426S. PMID: 7495242 Vitamins for Chronic Disease Prevention in Adults: clinical applications. Fairfield KM, Fletcher RH. JAMA. 2002;287:3127-3129.) Food-related illness and death in the United States. Mead PS, et al. Emerg Infect Dis. 1999 Sep-Oct;5(5):607-25. Review. PMID: 10511517 American Association of Poison Control Centers annual reports FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION: Unintentional Poisoning Deaths—United States, 1999-2004. JAMA, March 28, 2007; 297: 1309 - 1311. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Lazarou J, Pomeranz BH, Corey PN. JAMA. 1998 Apr 15;279(15):1200-5. PMID: 9555760 Washington Post reported in its 7/21/06 edition on an Institute of Medicine study released a day earlier on the toll of improperly prescribed drugs. http://www.youtube.com/watch?v=qxAR7waukVc

More nonsense in vitamin research

More nonsense in vitamin research By Neil E. Levin, CCN, DANLA A report in Archives of Internal Medicine, an AMA journal, tells us that “the Women’s Health Initiative study provided convincing evidence that multivitamin use has little or no influence on the risk of common cancers, CVD, or total mortality in postmenopausal women.” [i] A closer look at that report reveals serious shortcomings in its references and logic, leading to questions about its validity. In spite of these defects, this report got extensive press coverage (“Study Says Multivitamins Not Effective”[ii]) to promote the view that multivitamins are worthless. Having read the report and reviewed its references, I have serious questions about its importance, which I can back up by reviewing some of its own references. First of all, on what basis do the authors base their assertion that this report was needed? Actually, on pretty flimsy grounds. They list two references to justify the belief that there is a common “belief that these preparations will prevent chronic diseases, such as cancer and cardiovascular disease (CVD)”, which this report claims to disprove. Their first reference (by the lead author of the current report) actually states that multivitamin nutrients have been effective and accepted in medical practice for the prevention of other conditions: “First, research findings published throughout the past 10–20 y have established that some supplements are very effective for disease prevention and their use has become a part of routine clinical practice [e.g., folic acid during the periconceptional period to reduce the risk of neural tube defects and iron to prevent or treat anemia during pregnancy].” This statement indirectly undermines the underlying argument in the current report that vitamins are worthless against chronic disease. This same reference directly undermines the current report by asserting that most people use multivitamins for general health, not for prevention of serious diseases as is claimed in the current report: “Multivitamins (with or without minerals), the supplements most commonly used by American women, are most likely to be used to maintain general good health.” While this reference mentions that most American women with cancer do take vitamins, it does not pretend to know why they do so. In fact, there is no assertion that people claim to take vitamins to prevent cancer and CVD, and this reference actually gives alternative reasons for that use by patients with those conditions. This reference, like the current study by the same lead author, is dismissive of a law (DSHEA) regulating dietary supplements; and while it decries this law as reducing regulation in some areas, it ignores significant increases in scrutiny that the same law establishes, which I will explore in a subsequent section. To me, for the lead author to twice publish reports focusing on perceived negatives in the law while ignoring its clear positives and other applicable laws that increase federal regulation - implies an agenda that goes beyond scientific inquiry. 1 [iii] [iv] [v] The second reference listed for justifying the report also does not provide the supposed justification. On the contrary, it states, “Generally, participants took multivitamins to feel better… Nearly half of participants reported that they take multivitamins because it is hard to eat a balanced diet.” [vi] An objective observer reading these two references finds that they do not provide the promised justification for testing their own assertion that people take multivitamins to prevent cancer and CVD. Obviously, the current authors have not provided adequate references to support their claimed hypothesis; their own references betray them. Next, the authors claim that dietary supplements are “an industry that is largely unregulated owing to the 1994 Dietary Supplement and Health Education Act [sic].” Two references are listed to defend this assertion. The first is the law itself, which actually creates clear new authority for federal regulation of supplement manufacturing, federal regulation of labels and health claims, federal regulation of new ingredients, making illegal any mislabeled or adulterated products, etc. A fair reading of this law, and of the subsequent regulations that have been written to enforce it, including the mandatory Good Manufacturing Practices currently being implemented, do not support the authors’ claim. [vii] [viii] The second reference given also fails to support its use as a justification for the belief that supplements are largely unregulated: “DS are regulated under food law, but with certain provisions that apply only to DS…Health claims have already been authorized for folic acid and calcium, but not for several others. In 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed, it expanded and clarified the definition of DS, specified additional requirements for safety and provided for four types of claims of nutritional support…Although S/F [affecting the structure and functions of the body] effects result from both foods and drugs, representation that a product will treat, cure, mitigate or diagnose a disease is reserved for drugs.” [ix] The current report also fails to note industry-supported legislation that now requires serious adverse events to be reported to the FDA’s MedWatch system, which serves as an early warning system for safety problems. [x] We have seen that the first two claims in the current report, namely that people take multivitamins to prevent certain chronic major diseases and that dietary supplements are largely unregulated, are not supported by the report’s own selected references. In other words, there is not any real justification provided to support the need for this particular report. How could the authors cite references that don’t really support their claims? How does this undermine their reasons for doing this study? Another problem is that the current authors rather arbitrarily ignore numerous FDA-approved health claims for dietary supplements in their argument against the use of multivitamins to prevent chronic diseases, including the benefits of calcium for osteoporosis, fiber to prevent coronary heart disease, soy protein to prevent coronary heart disease, plant sterol/stanol esters and risk of coronary heart disease, potassium and the risk of high blood pressure and stroke; claims that already have met the agency’s Significant Scientific Agreement (SSA) standard. [xi] Even more bizarrely, they ignore substantial scientific agreements that were mentioned in the lead author’s own previous publication (which is referenced by the current report) which identified an accepted use of “iron to prevent or treat anemia during pregnancy” and reported “at least 35 randomized-controlled trials have shown that supplemental calcium or calcium–vitamin D combinations increase bone mass and decrease fracture risk in adult females.” 6 Yet the current authors claim: “Despite the widespread use of supplements and the strong consumer beliefs about benefits, convincing scientific data to support efficacy are lacking. With the exception of recommending a folic acid–containing supplement to women of childbearing potential and advising avoidance the use of high-dose beta carotene supplements by smokers, current data are insufficient to formulate public health recommendations for dietary supplement use for otherwise healthy persons.” Also, the FDA has also approved a number of less definitive Qualified Health Claims (QHCs) including calcium and colon/rectal cancer & calcium and recurrent colon/rectal polyps, green tea and cancer, selenium and cancer, antioxidant vitamins & cancer, omega-3 fatty acids & coronary heart disease, B vitamins & vascular disease, phosphatidylserine & cognitive dysfunction and dementia, chromium picolinate & diabetes, calcium & hypertension, pregnancy-induced hypertension and preeclampsia. [xii] The FDA-Approved Health Claims and QHCs are the only disease claims authorized for dietary supplements in the United States, with all others prohibited under the supposedly deregulating DSHEA law. 7 Another reference mischaracterization is the authors’ statement that “One study of more than 1 million Americans reported no association of multivitamin use with total mortality, coronary heart disease mortality, or cancer mortality.” [xiii] If, in fact, one were to read the reference carefully, one might find a more contradictory and less definitive tone: “Because CPS-II collected information on vitamin supplement use only once, in 1982, our measurement of duration of use is imprecise, and we potentially misclassify people who changed their use of multivitamin during the 7-year follow-up. This is an important limitation and may explain why we did not find a reduced risk of colon cancer among women with long duration of multivitamin use, as was found in the Nurses’ Health Study, which had repeat assessments of multivitamin use.” The imprecise nature of this reference must be emphasized. The Cancer Prevention Study II (CPS-II), which relied on a single survey of multivitamin use to classify as users those who claimed to have taken a multivitamin of any strength at least once during the month preceding the survey, was likely to be more and more inaccurate over time, and wherein only about half of the people surveyed claimed to have taken their multivitamin supplement daily during the previous month, is not a strong reference because its weak design does not establish any definitive effects clearly attributed to multivitamins. 13 Contrast this with the admittedly more rigorous Nurses’ Health Study, showing benefits in those taking supplements that were validated by repeatedly assessing whether or not the subjects kept taking their vitamins. [xiv] While the current report has an 8-year follow up period, the Nurses’ Health Study reported significant benefits only after 15 years of multivitamin use, concluding that such “Long-term use of multivitamins may substantially reduce risk for colon cancer.” This is another indication that the current report’s authors have failed to design their study in such a way as to follow previous successes and avoid known shortcomings of previously published studies; surprisingly, not even the ones that they themselves have referenced or written. By looking at only half as much time as was previously shown to be effective, they have produced a far less rigorous and less convincing report. The incubation period of cancers and heart disease is often estimated to be many years. As the National Cancer Institute reports, “Prostate cancer often does not cause symptoms for many years.” [xv] Other sources confirm the lengthy breeding time of cancers. Mouth cancer has a ten-year incubation period. [xvi] Because “the “incubation period between HPV infection and development of invasive cervical cancer is long, prevention of cancer by a vaccination programme will not be obvious for 10 to 20 years.” [xvii] Asbestos dust can cause lung cancer some 10 to 30 years after exposure. [xviii] Cervical cancer “has a long incubation period, between three to 17 years.” [xix] Likewise, “the ‘incubation period’ between exposure to major coronary risk factors and the maximum effects on mortality may be 10 years or more.” [xx] In the current report, “stress multivitamins” [sic] consisting of B-Complex vitamins along with additional factors such as vitamin C or single minerals were classified as multivitamins, though they could lack essential vitamins A, D, and E, as well as most or all of the essential minerals. This is not a normal definition of a multivitamin formula. Stress formulas are normally considered B-Complex supplements that are fortified with one or more additional nutrients to help the body deal with stress, but not as a general all-in-one daily nutritional supplement. People tend to take stress supplements because they feel under stress, not as a general insurance against incomplete diets as multivitamins are taken. 3,6 While the percentage of subjects in this category is small, I question why they would be included as multivitamin users in the current report at all. Perhaps this design flaw betrays a lack of understanding of the topic being investigated, with a strangely unscientific willingness to throw too many doses and formulas in the supposedly controlled mix of variables. In the case of multivitamins, most studies have shown overwhelmingly positive effects; such as one report evidencing reduced infections in nursing homes with vitamins over placebo (73% vs. 43%). Intervention was with a multivitamin containing beta-carotene. Infection-related absenteeism was higher in the placebo group than in the treatment group (57% vs. 21%). Perhaps most importantly, 93% of participants with diabetes mellitus reported an infection versus only 17% of those receiving supplements. [xxi] Interesting, the current report being reviewed also indicates that nonusers had a higher rate of diabetes treatment than multivitamin users; nonusers were treated at a rate of 5.2% while users ranged only from 2.7 to 3.5%. Nonusers also had slightly lower rates (81.4%) of mammograms compared with users (85.7 to 87.2%), which could imply greater rates of undetected breast cancer that may confound comparisons. 1 Another study reported in the Journal of the National Cancer Institute looked at death rates in a population given multivitamins or other nutrients. [xxii] After supplements were given for 5.25 years in the general population trial of 30,000 people, significant reductions in total [relative risk (RR) = 0.91] and cancer (RR = 0.87) mortality were observed in subjects receiving beta-carotene, alpha-tocopherol, and selenium combined. These nutrients are common in multivitamin formulas. The same researchers reported on a subgroup of 3,318 persons with esophageal Dysplasia (a precursor to esophageal cancer) that was given either a multiple vitamin-and-mineral supplement or a placebo for 6 years. In this portion of the trial, a trend towards small reductions in total (RR 0.93) and cancer (RR = 0.96) mortality were observed that did not reach statistical significance. In any case, no increase in cancer rates was noted in the group taking multivitamins; there was actually a possible small benefit in terms of reducing this risk. The participants getting the multivitamin took a daily beta-carotene capsule along with two multivitamin tablets. This was a group of subjects at high risk of getting throat cancer. [xxiii],[xxiv] Another problem with the current study is that these are nutrients and there are several important yet uncontrolled variables preventing meaningful conclusions: * The same nutrients are found in people’s diet, confounding researchers more used to novel drug studies who may be unfamiliar with the need to control additional variables in nutrient study design * The variety of formulations and nutrients included prevent a meaningful comparison by individual or groups of vitamins or minerals, present or absent * The potency of various nutrients taken could vary from absent to very high; there is no dose-dependent data possible in this particular study design that lumped together a wide range of non-homogenous dietary supplements In conclusion, there are many basic omissions and errors in this report’s rationale and design that should have dramatically reduced its importance and avoided a media frenzy over its flimsy conclusions. Unfortunately, nutrient studies often lack adequate critical review and the researchers tend to jump to unsupported conclusions by ignoring important variables. In this case, one problem was the design of a study that was simply too short to show any benefits. Another is the absolute lack of control over potencies and nutrient content. Rather than blaming the vitamins, it was probably pre-existing conditions and supplemental intervention was too little, too late. This report’s authors seem to lack objectivity by referring to an industry that has had numerous new regulatory controls imposed as “unregulated”. They have also chosen to ignore numerous approved health claims for vitamins, as well as evidence of benefits for those suffering from diseases other than cancer and cardiovascular disease. Additionally, they have described unsubstantiated motives for why people take vitamins, designing a study that was too short and included too many uncontrolled variables to be definitive, thus undermining their entire project’s basis and conclusions. Nutrient studies are simply more complex than drug studies and require a much higher level of careful planning to ensure meaningful results and eliminate as many variables as possible. In this case, I fear that the current report failed to do this, in the process generating much heat but little light on the topic.

REFERENCES [i] Neuhouser ML, et al. Multivitamin Use and Risk of Cancer and Cardiovascular Disease in the Women's Health Initiative Cohorts. Arch Intern Med. 169(3), 294-304. FEB 9, 2009 [ii] WSAV-3 TV, NBC affiliate: http://www.wsav.com/sav/news/science/health_med_fit/article/study_says_multivitamins_not_effective/9446/ [iii] Neuhouser ML. Dietary supplement use by American women: challenges in assessing patterns of use, motives and costs. J Nutr. 2003 Jun;133(6):1992S-1996S. Review. PMID: 12771352 [iv] http://www.fda.gov/opacom/laws/pl109462.html [v] http://www.cfsan.fda.gov/~dms/ds-labl.html [vi] Neuhouser ML, Patterson RE, Levy L. Motivations for using vitamin and mineral supplements. J Am Diet Assoc. 1999 Jul;99(7):851-4. PMID: 10405685 [vii] Dietary Supplement and Health Education Act of 1994, Pub L No. 103-417, 103rd Cong (1994). [viii] http://www.cfsan.fda.gov/~dms/supplmnt.html [ix] Hathcock J. Dietary supplements: how they are used and regulated. J Nutr. 2001 Mar;131(3s):1114S-7S. Review. PMID: 11238828 [x] http://www.cfsan.fda.gov/~dms/ds-rept.html [xi] http://www.cfsan.fda.gov/~dms/flg-6c.html [xii] http://www.cfsan.fda.gov/~dms/qhc-sum.html [xiii] Watkins ML, Erickson JD, Thun MJ, Mulinare J, Heath CW Jr. Multivitamin use and mortality in a large prospective study. Am J Epidemiol. 2000 Jul 15;152(2):149-62. PMID: 10909952 [xiv] Giovannucci E, Stampfer MJ, Colditz GA, Hunter DJ, Fuchs C, Rosner BA, Speizer FE, Willett WC. Multivitamin use, folate, and colon cancer in women in the Nurses' Health Study. Ann Intern Med. 1998 Oct 1;129(7):517-24. PMID: 9758570 [xv] National Cancer Institute: http://www.cancer.gov/cancertopics/factsheet/Detection/early-prostate [xvi] Mouth Cancer Foundation: http://www.rdoc.org.uk/chewing_tobacco_risk.html [xvii] Lowndes CM, Gill ON. Cervical cancer, human papillomavirus, and vaccination. BMJ. 2005 Oct 22;331(7522):915-6. No abstract available. Erratum in: BMJ. 2005 Nov 12;331(7525):1120. PMID: 16239668 [xviii] Ministry of Environment of the Republic of Korea: http://eng.me.go.kr/docs/sub2/policy_view.html?topmenu=C&cat=250&class=14 [xix] Indonesian Cancer Foundation: http://www.cvcradio.in/news/blogs/eye-on-indonesia/cervical-cancer-the-number-one-killer-of-indonesian-women [xx] Rose G. Incubation period of coronary heart disease. 1982. Int J Epidemiol. 2005 Apr;34(2):242-4. Epub 2005 Mar 11. PMID: 15764698 [xxi] Liu BA, et al. Effect of multivitamin and mineral supplementation on episodes of infection in nursing home residents: a randomized, placebo-controlled study. J Am Geriatr Soc. 2007 Jan;55(1):35-42. Erratum in: J Am Geriatr Soc. 2007 Mar;55(3):478. PMID: 17233683 [xxii] Blot WI, Li IY, Taylor PR, et al. Nutrition intervention trials in Linxian, China: supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population. J Natl Cancer Inst 1993:8ı:1483-92 [xxiii] Li JY, Taylor PR, et al. Nutrition intervention trials in Linxian, China: multiple vitamin/mineral supplementation, cancer incidence, and disease-specific mortality among adults with esophageal dysplasia. J Natl Cancer Inst. 1993 Sep 15;85(18):1492-8. PMID: 8360932 [xxiv] Blot WI, et al. The Linxian trials: mortality rates by vitamin-mineral intervention group. Am J Clin Nutr. 1995 Dec;62(6 Suppl):1424S-1426S. PMID: 7495242

Second Opinion on Herbs

Second Opinion on Herbs In a recent opinion, physician Henry I. Miller advocates a new way to regulate dietary supplements (DS), arguing that they are currently unregulated. Although a onetime FDA official and longtime industry critic, Dr. Miller seems out of touch with the current state of DS regulation, including recent major advances in quality assurance by manufacturers. His bias against natural products is made evident by his use of the slur “snake-oil” to dismiss herbal products as simultaneously ineffective and “dangerous”. Many observers, including FDA commissioners during congressional testimony, have testified that the agency has all of the authority it needs to regulate DS. Recent advances include the FDA’s current imposition of mandatory Good Manufacturing Practices (GMP), which was authorized by a 1994 law (DSHEA) that Dr. Miller inexplicitly claims exempted DS from government oversight. That same law stipulates that supplements must not be mislabeled or adulterated and the FDA has repeatedly taken action against such products, again proving Dr. Miller wrong. Manufacturers are now required to have procedures in place to assure product identity, potency and safety, as authorized by a law that Dr. Miller misrepresents. DS manufacturers supported a serious adverse event reporting (AER) law to track patterns of serious side effects. In the first year, the number of DS reports was significantly less than the FDA had predicted. An AER is casually linked to, but not proven to be caused by, a product. Dr. Miller’s assertion that foods and DS like herbs interfere with drugs (Miller’s ‘“real” medicines’) is telling. Is it professional bias to claim that foods, herbs and vitamins are unnecessary nuisances that are interfering with all-important medical treatment? In fact, these legendary interactions appear to be a minor issue. When the Mayo Clinic did a large patient survey to scientifically assess the risk, it reported that there were few such interactions, none serious, limited to only a handful of drug types and a few supplements such as garlic. Dr. Miller’s proposal for a new voluntary oversight entity for herbal products to correct a supposed lack of regulation is illogical; such entities already exist, and how could a voluntary program replace adequate regulation? His seeming ignorance of the current regulatory status of herbs is troubling, undercutting his rationale for such tinkering. Statistically, dietary supplements are safer than drugs and even safer than eating a meal, as recent AER reports prove. DS labeling and manufacturing are currently well-regulated. I suggest that studying drug-nutrient-herb interactions and addressing these on drug labels – where they belong - is a far wiser strategy than creating a “voluntary oversight” entity for dietary supplements, especially as there are already voluntarily GMP-certified brands available.

More about steroids and DSHEA

The fact that CNN removed the video and corrected its text report on DSHEA by substituting some of the original quotes with quotes from US regulatory agencies adequately confirms that my original criticism was both factual and confirmable. Make no mistake; it is currently illegal - under DSHEA - to put undeclared ingredients like steroids and steroid precursors in a dietary supplement. The fact that some outlaws have made supplements containing illegal drugs - without declaring them on their labels - is not a reflection on the legally operating dietary supplement industry; any more than a drug smuggler hiding contraband in a teddy bear is representative of all teddy bear manufacturers or a hollowed-out book is representative of all publishers. My contention is that steroids are often being deliberately and illegally added to “spike” certain dietary supplements, which are not "contaminated" in the sense that the substance was not accidently added. The addition of an undeclared active ingredient is "adulteration" under DSHEA, whether deliberate or accidental, and adulteration is quite clearly illegal. The FDA has full power to remove adulterated substances from the market under DSHEA and other laws; there is absolutely no legal protection for these unlawful “supplements”. It’s not a law’s fault if a government regulatory agency fails to vigorously enforce it, despite having clear authority in that area to act. Yet that’s precisely the kind of misdirected criticism that some critics of the industry propose: blaming weak enforcement on a perceived legal emasculation which simply isn’t there. This, despite the fact that the dietary supplement industry’s legislative allies have introduced bills to add funding to the FDA specifically so the agency could enforce DSHEA more strictly; which is additional proof that the industry does not avoid reasonable regulation and in fact prefers it to false claims of being “unregulated”. The Dietary Supplement and Nonprescription Drug Consumer Protection Act now requires all serious adverse events to be reported to the FDA within 15 business days. The supplement industry also supported this Act, knowing that it had to prove the safety of its products and show responsibility to the public and to lawmakers. The fact that supplement manufacturers supported the Anabolic Steroid Control Act of 2004 (HR 3886), banning androstene-type substances, should also reflect favorably on their commitment to responsible regulation and a desire to protect the public health. Even that has not quieted some critics. It is precisely an industry revulsion to outlaws posing as legitimate manufacturers that has repeatedly prompted industry support for additional government regulation. Industries do not typically request more regulation, so this stance should be more notable. Still, in my opinion it is illogical to blame a law for the actions of outlaws. Outlaws fill a perceived need at a high price, just like other drug dealers, but to consider their products to be accidentally “contaminated” is naïve, at best. Under authority granted to it by DSHEA, and after years of industry prodding, the FDA has only recently rolled out mandatory current good manufacturing practices (cGMPs), requiring safety and identity testing. There are a number of manufacturers already certified as operating under independently certified GMPs, giving consumers a high assurance against inadvertent contamination. Steroids and anabolic steroid precursors are currently regulated as prescription drugs. So no dietary supplement manufacturer has any legitimate, legal reason to use these controlled substances in any of their products, whether on or off the label, making accidental contamination quite implausible. The FDA has not claimed that DSHEA blocked its ability to regulate dietary supplements. Actually, several FDA commissioners have testified to Congress that they already had adequate enforcement powers under DSHEA; and that was before the introduction of additional regulation such as cGMPs, adverse event reporting, the anabolic steroid precursor ban, etc. It is irresponsible to continue to echo allegations that have already been disproved, taking on faith the word of cheaters who have been revealed and are trying to point the blame elsewhere. It’s ludicrous to try to shift blame on a law passed some 13 years ago, a law that specifically prohibits adulterated products. I think that the baseball player’s union leader successfully did just that, knowing that he had a receptive audience in a leading DSHEA critic. But the resulting publicity, repeating the tired old complaint of supplements being “unregulated”, does not constitute any form of real evidence, flying in the face of so many contrary facts. If you are still in doubt, don’t take my word for it. Please read the various pieces of legislation or check the websites of the regulating agencies and see for yourself. I have done both and base my writings solely on these demonstrable facts and reputable references, including official government agencies.

Steroids in Baseball Blamed on Dietary Supplements

1. Say It Ain’t So, Donald Steroids in Baseball Blamed on Dietary Supplements In the latest twist in the baseball players’ steroid use scandal, congressional hearings following the release of the Mitchell Report have generated a new controversy: MLB players union chief Donald Fehr has apparently tried to shift part of the blame to poor regulation of dietary supplements, suggesting that players may have accidentally ingested banned drugs due to poor manufacturing practices in an industry deregulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Let me be blunt: What a bunch of bull! First of all, it is ridiculous to try to point the blame at dietary supplements as the cause of professional athletes’ steroid use, implying that the players were doped against their will. I can’t believe for a minute that world-class athletes don’t have their expert trainers carefully scrutinize products before using them, and then only as part of a complete nutritional program. Either the players or their trainers know, or should know, what they’re taking. Does anyone really believe that players are impulsively buying crappy supplements in gas stations? Please! In fact, DSHEA does not allow steroids to be used in dietary supplements. DSHEA actually makes it illegal to sell dietary supplements containing any undisclosed ingredients, making them by definition “adulterated” and subject to strict FDA action. DSHEA also requires that all health claims be submitted to the FDA, and prohibits any new dietary ingredients without first registering safety information with the agency. The Bioterrorism Act also requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA. Please check the FDA website and see it all for yourself. (3) It is plainly illegal to sell any restricted substances - drugs - without OTC status or a physician's prescription, and all drugs require specific labeling. It is also illegal to sell anabolic steroid precursors like androstene in this country because of another law that was strongly supported by the dietary supplement manufacturers. A New York Daily News article (2) uncritically echoed the unbelievable argument that supplements are now unregulated because of DSHEA and reprinted an outrageous quote by someone who should know better, alleging that “DSHEA was created in order to give the supplement manufacturers a huge shield so they could distribute steroids”, despite the obvious restrictions and regulations that the law imposes. Mr. Fehr’s questionable allegations were featured on AOL, CNN, ESPN, and news feeds that went around the world; sometimes with sympathetic journalists adding similar sentiments and supporting quotes. But we can see the facts for ourselves on the FDA’s own website, proving it ain’t so. (1) Dietary supplement manufacturers also supported FDA’s dramatically increased regulation of supplement manufacturing (cGMPs, or current Good Manufacturing Practices); which was authorized by DSHEA, by the way. The industry even supported mandatory reporting of serious adverse events linked (possibly related) to their products, which is now in effect. It is clear by the record that the dietary supplement industry has consistently supported increased regulation of its own operations and products as a good faith effort to protect its customers, an estimated 2/3 of American adults, even though DSHEA has obviously given the FDA additional regulatory authority over a number of areas. The industry has even lobbied Congress for additional FDA funding to improve the agency’s enforcement of dietary supplement regulations, an incredible effort by an industry to increase government regulation of that same industry. This support should come as no surprise, since the industry is focused on the scientific use of nutrition as a means to offer healthy alternatives for people trying to avoid the use of drugs in the first place. Drugs are dangerous controlled substances, by definition, and nutrients are regulated as a special food category. In this case, Rep. Waxman seemed quite willing to believe the hype, but his history evidences his unwavering belief that the dietary supplement industry is under-regulated, even as more and more layers of regulation are added. Could it be that Mr. Fehr simply, and successfully, gambled that he could distract his inquisitor by providing another target that might be welcomed by such a prominent industry critic? In my opinion, this whole baseball doping controversy really has nothing to do with sloppy supplement manufacturing or poor regulation of the dietary supplement industry, which I consider slanderously false accusations, and everything to do with deliberate illegal drug dealing and steroid use by those who are now desperately trying to find a scapegoat. 1. http://www.cfsan.fda.gov/~dms/ds-ind.html 2. http://www.nydailynews.com/sports/baseball/2008/01/16/2008-01-16_donald_fehr_admits_mlb_players_union_res.html?page=0 3. http://www.cfsan.fda.gov/~dms/supplmnt.html

Selective facts produce poor journalism (or science).

Selective facts produce poor journalism (or science). For example, the Women's Health Study had a 7% reduction in major cardiovascular events with vitamin E, a number that was not significant. But there was a significant 24% reduction in cardiovascular death in the vitamin E group. Would you characterize that as a failure for vitamin E? The media did. Yet, the authors of the study admitted that, "This was largely attributable to fewer sudden deaths in the vitamin E group (38 vs 51 among women assigned to placebo) and fewer deaths from other cardiovascular disease (ie, deaths due to cardiovascular diseases other than ischemic heart disease and cerebrovascular disease, 20 vs 34, respectively)." The Williams College ginkgo study in JAMA allowed participants to miss up to 6 daily doses over a 2-week period (nearly 50%!) before they were eliminated for non-compliance. It also tested only one brand of ginkgo (Ginkoba) on healthy volunteers for only six weeks, with results (by convention) not applicable to other brands. This was an obvious attempt to see whether a quick, drug-like effect could be obtained from a short course of supplementation. Longer term studies are more authoritative, especially if compliance is better. The CoQ10 statement is laughably wrong: "Coenzyme Q10 has not been carefully tested to see if it is safe and effective. Because coenzyme Q10 is sold as a dietary supplement rather than a drug, it is not regulated by the US Food and Drug Administration." This is a complaint that the FDA does not test individual dietary supplement products for potency or approve individual label claims. The agency does have the longstanding right to veto dietary supplement label claims and to remove any mislabeled or adulterated product from the national market. This contrasts with the FDA's explicit approval of drugs and drug claims, though the agency doesn't test individual pharmaceuticals for potency or safety, either. Of course, the FDA would take issue with their supposed inability to regulate dietary supplements. They even claim the opposite on their web page. Note the first 4 words: "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising." regarding the CNN report: http://www.cnn.com/2007/HEALTH/04/09/chasing.supplements/index.html

The FDA has a legal framework for authority over dietary supplement safety and accurate/proper labeling

Senate Bill 1082, passed 93-1 on 5/9/07 SEC. 605. ADULTERATED FOOD REGISTRY. (a) Findings- Congress makes the following findings: (1) In 1994, Congress passed the Dietary Supplement Health and Education Act (P.L. 103-417) to provide the Food and Drug Administration with the legal framework to ensure that dietary supplements are safe and properly labeled foods. (2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (P.L. 109-462) to establish a mandatory reporting system of serious adverse events for non-prescription drugs and dietary supplements sold and consumed in the United States. (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act will serve as the early warning system for any potential public health issues associated with the use of these food products.

Stop the FDA from classifying CAM as drugs!

Regarding: Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf This proposal is in a public comment period. I believe that it goes too far in re-classifying natural products as drugs based solely on practitioner claims. While the concept of the FDA determining which regulations certain products or procedures fall into seems reasonable, the agency's attitude that they can call a vegetable juice product a drug just because someone suggests using it to treat a disease should be considered unreasonable. The FDA already has the power to regulate drug claims, but not to treat a food (including dietary supplements) or cosmetic item as a drug simply because of an unapproved claim or use. In other words, the act of claiming that a product can treat a disease is already regulated under current laws concerning drug claims on product labels or advertising. It is too confusing and illogical to treat an individual product sometimes as a food and sometimes as a drug, varying with the label claim, especially when the drug claim is already illegal. The FDA's given example of cranberries, which do have a biological function of helping to inhibit the implantation of new bacterial colonies in the urinary tract but do not actually remove existing colonies, is very misleading. Cranberries cannot be used to treat an existing infection, though it may aid the body in managing urinary tract health. The unapproved (and inaccurate) disease claim is already prohibited under current law (DSHEA), yet the FDA now proposes to regulate illegally labeled cranberry products as drugs if someone does make this illegal claim! The FDA did not propose that foods or dietary supplements be generally regulated as drugs and only be available by prescription. The agency is actually trying to prevent doctors from making drug claims for supplements and foods. Yet physicians can currently make off-label prescriptions for drugs! The distinction is artificial, and the drugs are the more dangerous products by far! Concerned citizens are encouraged to submit their own comments by the end of the month. I suggest stressing your strong support for health freedom, which includes the ability to freely access CAM services and products (including dietary supplements) without undue government interference. You may also wish to support CAM practitioners' ability to prescribe natural products without the FDA treating them as unapproved drugs. If the agency applies this same logic to other CAM modalities, the FDA's proposed enforcement of current regulations on licensed, credentialed health practitioners would be a disaster. The comment period ends May 29, 2007. Please send your comments to the FDA to oppose this new power grab: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA

Natural Causes is cause for concern about journalism

Natural Causes To those deciding whether this book is worthy of purchasing, I find that many of the author's claims are overblown. Some are demonstrably untrue. Mr. Hurley's inflammatory rhetoric is apparently at odds with official FDA statements, because on its website and in Congressional testimony the agency has repeatedly stated that it has adequate power to regulate dietary supplement safety and quality, which the author denies is true. DSHEA (the Dietary Supplement Health and Education Act) is NOT a deregulation bill. It took a misunderstood food category and elevated its regulation to almost that of pharmaceuticals, allowing the FDA to ban drug and disease claims, control manufacturing quality through mandatory Good Manufacturing Practices (GMP), have veto power over label claims, and make manufacturers bear responsibility for mislabeled, adulterated or unsafe products. What was stopped by DSHEA was inexplicable FDA harassment of supplements, stopped only by outraged federal judges. DSHEA was the compromise bill that gave more power to the FDA while preventing the grossest abuses of its power. Dietary supplement plants are FDA inspected, while also under the sanitation and health laws of local and state governments. Other quality inspectors keep manufacturers honest; for example, GMP, organic and kosher certifiers. A documented paper trail is required for every step in the production of products. The FTC also regulates dietary supplement advertising, including monitoring Internet websites. The dietary supplement industry strongly supported the recent Adverse Event Reporting Act that requires manufacturers to report all serious adverse events to the FDA. Some manufacturers have already been doing this voluntarily, but have received very few, to date. This evidences their commitment to safety. Dietary supplement industry associations have quality programs that require registration and random testing for active ingredients in products, so member companies are of a significantly higher level of quality assurance than other manufacturers. Of course, not all natural products are 100% safe or 100% effective for every person. But, checking poisoning death figures from the American Association of Poison Control Centers, I see that supplements are safer than most other products: there were only 5 accidental deaths linked (reported as possibly due) to dietary supplements over a 3-year period. In the same 3-year reporting period, there were 67 deaths from plain aspirin, 50 from aspirin combinations, 48 from pesticides, 7 from cosmetics, 66 from household cleaners, 171 from plain acetaminophen, and 446 from acetaminophen combinations. The medical journal JAMA reports that there are over 100,000 deaths a year from pharmaceutical drugs that are used as directed, and many more from misperceived drugs. How many dies from the FDA-approved drug Vioxx? How many from mood altering and cholesterol lowering drugs? How many from cardiovascular disease aggravated by synthetic hormone replacement therapy? The tryptophan that caused deaths in the late 1980's was reportedly produced by a pharmaceutical company using a prototype/unproven genetically engineered bacteria for the first time to produce the amino acid, which was then prescribed by a physician. How do dietary supplement companies get all the blame for this? While Mr. Hurley is correct that, normally, food is the best source of nutrients, there are some that are shown to be better absorbed from supplements than food, such as certain B vitamins. Compared with the admitted shortage of essential nutrients in the American diet and the dangers of prescribed and OTC drugs, most people feel better about the relative safety and utility of dietary supplements. Greater than RDA levels of vitamins are NOT toxic. Safe upper levels exist and are often far higher. Medical professionals frequently use mega-doses of Vitamin C, biotin, folic acid, vitamin B-12 and vitamin D with no serious adverse effects. Natural products companies exist because of a strong commitment to natural health, including product safety. Most natural products manufacturers would rather go out of business than harm their customers. Many people believe that natural products are more health promoting than synthetic drugs because the nutrients and gentler therapeutic agents are better tolerated by the body and encourage healing; not merely controlling symptoms like so many toxic drugs. And, yes, dietary supplements are backed by tens of thousands of published research papers showing their safety and efficacy. I read them daily. Perhaps Mr. Hurley just didn't pay enough attention in science class and is too focused on muckraking to notice his many errors. I give this book an "F". Neil E. Levin, CCN, DANLA board certified clinical nutritionist with diplomate in advanced nutritional laboratory assessment http://www.honestnutrition.com/

Wrong TIME

Wrong TIME By Neil E. Levin, CCN, DANLA The Time article “State of Reliefs: HOW THE CONTROVERSIAL YET POPULAR SUPPLEMENT BUSINESS EMERGED IN UTAH” (10/1/06) mostly deals with MLMs (multi-level marketers) rather than other types of dietary supplement companies, but there are a few problems with the reporting. Time relies on quotes from notorious anti-supplement partisans who do not often admit to the peer-reviewed science of supplements: the Mayo Clinic and Dan Hurley. It is not even possible that Mr. Hurley's claim could be true ("the vast majority of supplements taken by Americans have been proven to be unsafe, ineffective or both"). If so, the FDA and the majority of companies that really do care about consumers' health would have already voluntarily or forcibly pulled them off the market. The mainstream dietary supplement industry's primary motivation is to provide safe, effective natural products, not to hurt or scam people. Most dietary supplement companies are science-driven and their labels and claims are scrutinized for accuracy and compliance with federal laws, such as the law (DSHEA) that the article falsely accuses of reducing FDA authority. Even the FDA itself denies this on their own website, as well as in the Congressional testimony of several FDA commissioners. DSHEA disallows any dietary supplement claims related to disease, so companies only offer documented structure-function claims as to how the supplements may affect the individual. These claims are submitted to the FDA for scrutiny and the agency has the power to ask for changes to these claims. The law also provides that any ingredient introduced to the market after October of 1994 must have a New Dietary Ingredient packet submitted to the FDA with evidence of safety, as well as allowing the FDA to set rules for good manufacturing practices, so the article's claim that DSHEA "released manufacturers from demonstrating that products were safe before being sold" is not quite accurate. In my personal opinion, Ephedra was only banned because of the FDA's misrepresentation of this herb’s safety record and an arbitrary dismissal of all of its proven benefits to produce a slightly negative risk/benefit ratio. (1,2) Rand Corporation researchers actually reported that up to 155 reported deaths possibly linked to Ephedra were contradicted by its own review of published Ephedra studies that found no deaths, strokes or any serious side effects reported from using the herb, yet the Time report only reports the association of Ephedra to these deaths, despite a complete lack of evidence of cause and effect. (3) The Rand report also stated that Ephedra, with or without caffeine, provided a statistically significant increase in short-term weight loss compared to placebo: about 2 pounds per month for up to 6 months, which contradicts the FDA's decision that Ephedra has only risks and no benefits. Several other review studies have also concluded that Ephedra is safe when properly used. (4,5) And while the Time article implies that an appeals court rejected the safety record of Ephedra ("Utah company Neutraceutical Corp. [sic] is still arguing that lower doses are safe, but in August the firm was overruled by an appeals court"). But the court did not really rule on whether or not the herb is safe because it was narrowly focused on the FDA's authority to implement DSHEA. To read the original Time article, click on this link: http://www.time.com/time/insidebiz/article/0,9171,1541294-2,00.html REFERENCES: 1. 21 C.F.R. Pt. 119, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Published February 11, 2004) (Effective April 12, 2004) available at http://www.fda.gov/ohrms/dockets/98fr/1995n-0304-nfr0001.pdf 2. Federal Register: February 11, 2004 (Volume 69, Number 28). 3. Shekelle PG, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA. 2003 Mar 26;289(12):1537-45. Epub 2003 Mar 10. PMID: 12672771 4. Morgenstern LB. Use of Ephedra-containing products and risk for hemorrhagic stroke. Neurology. 2003 Jan 4;60(1):132-5. Erratum in: Neurology. 2003 Mar 25;60(6):1055. PMID: 12525737 5. Soni MG, Carabin IG, Griffiths JC, Burdock GA. Safety of ephedra: lessons learned. Toxicol Lett. 2004 Apr 15;150(1):97-110. Review. PMID: 15068827