Vitamin D Testing & 3rd Party Certification

A letter in a recent medical journal stated that in a recent study the only vitamin D supplement to pass the authors’ potency testing was a USP-verified product.  The authors explicitly endorsed the USP certification program and the brands that utilize this standard. [1] News reports are duly reporting that consumers should only purchase USP-verified Vitamin D. (12) But the data in the study did not justify that conclusion, so those news reports were based on inaccurate information and are therefore wrong.  

The  authors claimed that “the Food and Drug Administration [FDA] does not regulate vitamin D supplements.”  ¹  This is simply not true.  [2]  The FDA does indeed regulate all dietary supplements, including Vitamin D. ²  A summary of dietary supplement regulation is posted on that agency’s website. [3]^{, 9}   There are also various third-party summaries of current dietary supplement regulation available. [4]^{, [5], [6], [7], [8], 10} 

The USP-verified OTC standards require a potency of 90% - 110% of the active label claim, as the authors point out.  But this allows levels which are below the minimum required by the Dietary Supplement Health and Education Act of 1994 and the resulting FDA current Good Manufacturing Practices (cGMPs) that regulate supplement manufacturing and labels.  The federal cGMPs require greater or equal to 100% potency; the capsules must at least match the label claims.  This means that a product tested at 99% potency would be acceptable by the USP standards, but would not meet the FDA cGMP standards set in the regulations governing dietary supplements.  This also means that a USP-Verified product could actually be deemed “misbranded” under these regulatory standards, and therefore illegal. So you can quickly see that the USP’s OTC (over the counter) drug standard is not applicable to dietary supplements. ¹⁰  

In the letter published in that medical journal the authors reported that four of the 12 brands tested had samples that met the authors’ standards as being within their stated acceptable range of variance from label claim, yet only one of these was from a USP-verified company. Why was that brand singled out as superior when at least 3 other brands were within those same chosen (and as we discussed already, unacceptable) limits? And why did the authors specifically endorse that brand‘s certification program when admittedly one of the two USP-verified brand’s products tested actually failed this testing? ¹  That’s a 50% failure rate, and the one USP-verified product that didn’t fail that standard still did not reliably meet the cGMP legal standard.  To me, an experienced science writer, these inconsistencies of logic suggest a bias against the non-USP-verified brands and an unjustified conclusion that conveniently met the authors’ preconceived notions of dietary supplements being ‘unregulated’.  

In this study, only 5 brands are USP-verified (Berkley & Jensen, Kirkland, Nature Made, Sunmark, TruNature).  All are sold in mass market (Albertsons, BJ’s Wholesale Club, Costco, CVS, Eckerd, Giant, Health Mart, Hy-Vee, K-Mart, Kroger, Long’s, Osco Drug, Ralph’s, Rite-Aid, Safeway, Sam’s Club, Stater Bros, Super Valu, Target, Valu-Rite, Walgreen’s), not health food stores. [9] Brands sold in the natural products channel (health food stores) typically don’t verify their products to the non-compliant USP standards. Most good natural products brands are certified by different 3^rd party organizations that certify their compliance to the FDA’s cGMP standards, which are the law of this land.  [10]^, [11] We don’t know if any of the brands tested were third-party certified by these other organizations because the authors did not disclose those brands or discuss any other claims of third-party certification. ¹  

Why do people buy vitamins at health food stores instead of drug stores in the first place?  Many people reject some of the pharmaceutical ingredients that are commonly used in products sold in that channel but which are not used in vitamin products sold in the natural channel.  These questionable ingredients include petroleum and coal tar derivatives, talc, hydrogenated oil, artificial colors/flavors/sweeteners, crospovidone, butylated hydroxytoluene, and hypromellose.

The moral of this story is “don’t accept everything you read,” even if published by well-credentialed scientists in a “prestigious” scientific journal and dutifully reported by well-meaning news organizations.  Under U.S. law, USP-Verified is not an acceptable standard for dietary supplements because its standard fails to meet the legal requirements for dietary supplements.  Instead, look for dietary supplements that are third-party GMP-certified in order to assure that your vitamins are manufactured under proper conditions to assure safety and efficacy, and are properly tested to meet 100% of label potency as required by law.  

REFERENCES (links accessed Feb. 18, 2013)

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[1] http://archinte.jamanetwork.com/article.aspx?articleid=1570096

[2] http://www.fda.gov/Food/DietarySupplements/default.htm

[3] http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm071547.htm

[4] http://honestnutrition.blogspot.com/2013/02/how-dietary-supplements-are-regulated.html

[5] http://www.npainfo.org/NPA/Communications/SeparatingSupplementFactsfromFiction.aspx

[6] http://www.crnusa.org/leg_DSHEApub.html

[7] http://www.crnusa.org/leg_glance.html

[8] http://americannutritionassociation.org/newsletter/assessing-claims-functional-foods-nutritional-supplements

[9] http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements

[10] http://www.npainfo.org/NPA/EducationandCertification/GMPCertification/NPA/EducationCertification/NPAGMPCertificationProgram.aspx?hkey=d37fc8c5-7b43-4a6d-bcf4-af67d5814bfe

[11] http://www.npainfo.org/NPA/EducationCertification/GMPCertifiedCompanies.aspx

12 http://www.koinlocal6.com/news/local/story/Taking-Vitamin-D-Dont-trust-that-bottle/94U3oiVyCU2bv85MQxYDtw.cspx

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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

ADULT WEIGHT MANAGEMENT interview, Vitamin Retailer magazine, February, 2011

Weight management products have long been an important category for natural product retailers, partially because it is such a problem for many people to control their weight but also since many people shop in these stores because they want to use natural products that are free of potentially risky pharmaceuticals. As a gateway category for transitional shoppers that may be new to health food stores, weight management products become an important gauge of a commitment to meeting these people’s needs and thus keeping them as customers willing to try other products. Of course, nutritionists will suggest a comprehensive diet and supplement plan, rather than relying on “magic bullet” single products.

Good Manufacturing Practices (GMP) regulations have gone into effect over the past several years, raising the bar on manufacturers’ quality control practices. At the same time, mandatory Adverse Event Reporting (AER) was also implemented. Both of these regulatory mechanisms should increase consumer confidence and belie the myth that the industry is “unregulated”.

I believe that the glut of stories about Americans being overweight tends to make people more aware of their own lack of exercise and dietary restraint, which contribute to their excess weight. Of course, health scares and medical crises also alert people to their mortality and tend to motivate healthy dietary and other lifestyle changes. Today’s youth-obsessed media makes people want to look young and fit even past middle age. Plastic surgery, being expensive and with some risks, is far from a perfect solution. There are no shortcuts to health, only natural aids to good health. The very visible failures of both diet drugs and illegal products pretending to be dietary supplements illustrate the depth of the market and the need for effective natural weight management products.

Consumers tend to look for something that was recommended to them, either by a person or an authority. The person could be a family member, co-worker, or an acquaintance. The authority could be someone cited in the media, on the Internet, or a trusted trainer or health professional. Top categories are controlling appetite (satiety), increasing metabolism (thermogenics), and blocking the absorption of certain food components such as carbohydrates or fats (nutrient blockers).

Natural foods and fibers are part of the solution to maintaining healthy weight and blood sugar. These foods would include whole grains as well as fibers from various sources. Some of these fibers are gluten-free and/or organic, such as Flax, Acacia, Inulin, and Psyllium. Fibers also help satiety, the feeling of being full.

Consumers today are more concerned about the quality and safety of diet support products, so are looking for assurances of adequate quality controls and testing. Some parts of this process include method validation and development, stability testing, identity testing, microbiological testing, heavy metal testing, specification development, overseeing production, procuring samples and preparing them for testing, and even raw material vendor audits.

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

Sports Supplements Are Regulated

To the editor (Times Herald-Record, Hudson Valley, New York state):

Your special report, “Supplements for athletes stir serious debate” (June 29, 2010) is interesting but presents some misleading ideas.

For example, the quote that “18.8 percent of supplements are tainted with steroids or other illegal, potentially dangerous ingredients” is seriously flawed, since the percentage actually refers to 240 sports supplements tested, a tiny fraction of the tens of thousands of dietary supplements on the market. These products were actually tested 9 years ago when steroid precursors were legal; spiking them with steroids was always illegal. Today, thanks in part to the dietary supplement industry lobbying for a federal ban on steroid precursors, that product category is dead and this inflammatory quote does not reflect the present market. If any illegal drug is present in a product it is defined by law as an unapproved drug, not a dietary supplement, subject to FDA and DEA enforcement.

Regarding Senator McCain’s bill to more strictly regulate supplements: I met with him after the bill was introduced to present the inconsistencies between the actual bill and how he described it. Under the anti-bioterrorism bill of 2003 all dietary supplement manufacturers are already required to register with the FDA; as do all domestic or foreign food manufacturers selling in the US. Under several federal laws all ingredients already must be on dietary supplement labels. Failure to do so makes the products adulterated and subject to a range of FDA actions. His bill would actually have subjected each new product introduction to prior FDA approval, expanding the federal bureaucracy and amounting to a government takeover of the entire dietary supplement industry. Importing this Canadian-style regulatory scheme would duplicate that system’s failures: half as many products on the Canadian market, products considered safe in the US are effectively banned, waits of over 4 years to introduce variations of existing products, higher prices, etc.

Your series promises to disclose how the dietary supplement industry “is opposed to regulations.” That is absolute nonsense! The dietary supplement industry has long supported new laws and regulations that are reasonable, with these already in place: all vitamin companies must follow FDA-audited Good Manufacturing Practices requiring safety and identity testing, only FDA-approved ingredients can be used, steroid precursors are banned, and companies must disclose all complaints of adverse events requiring medical attention to the FDA within 15 days. The dietary supplement industry supports increased government authority to mandate product recalls in the Food Safety Bill. But the American people won’t stand for a major expansion of government power that gives bureaucrats absolute veto authority over each new consumer product, stifling innovation. That’s not only anti-capitalism, it’s un-American.

Original story
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100629/SPORTS/6290316/-1/SPORTS

This reply published:
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100709/OPINION/7090312

Reference:
http://multimedia.olympic.org/pdf/en_report_324.pdf

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

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/

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.

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

CNN: false report on dietary supplement regulation

CNN’s erroneous report on dietary supplement regulation was corrected after my complaint and correction By Neil E. Levin, CCN, DANLA www.honestnutrition.com A recent CNN text report and the accompanying video posted on its webpage asserted that dietary supplements are “unregulated” and that label and ad claims are made without any government supervision. 1 The video was shown on the CNN television network. Of course, one need only go to the FDA's own web site to find out that this is false. Even the claim that dietary supplements are "unregulated" compared to other food categories is preposterous. The FDA says that (I have bolded certain words in these quotes to emphasize that these are mandatory rules, or regulation): "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter)." The agency explains the scope of those regulations: "FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting [Neil's note: this has been superceded by mandatory adverse event reporting passed into law December 2006.] , and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising...Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA." Regarding the regulation of claims and labels, the agency says: "Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims, and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, or, in the case of advertising, with the Federal Trade Commission...Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim." "The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www .ftc.gov/bcp/menu-health.htm. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service." Regarding new ingredients, the agency says, "The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply." This rule does not apply to other food categories. Additionally, serious adverse event reporting (SAERs) is no longer voluntary. Manufacturers are required to report SAERs to the FDA within 15 business days of receipt, another distinction between dietary supplement regulation and rules for other regulated food categories. And the FDA, as authorized by DSHEA, is phasing in mandatory cGMPs (current Good Manufacturing Practices) for all dietary supplement manufacturers, focusing on assuring safety and proper identification of ingredients by setting strict rules for manufacturing procedures. This is another important regulatory distinction between dietary supplements and other food categories. POSTSCRIPT: I sent a short version of this correction to CNN on Monday, 1/14/08, and posted a long version on my blog. To their credit, CNN has now (1/17/08) posted a link to my blog entry (1) that had complained about the accuracy of its original report, has revised its text version on the CNN webpage to remove the errors that I pointed out to them and insert accurate quotes from the FDA website, and has pulled the video of that original report from the CNN webpage. (2) I acknowledge CNN’s corrections as responsible and applaud its efforts to quickly correct these errors when informed of them. My hope is that CNN will now be more vigilant in recognizing and challenging the common misperception that “dietary supplements are unregulated”, since even a quick fact check reveals that this is quite untrue. Even when those making these false claims are authorities, “experts” or health professionals, it would be helpful if journalists learn that such blanket condemnations are ‘red flags’ indicating that sources may be spouting personal opinions that may be inaccurate, biased, inflammatory, or even potentially libelous; and hopefully triggering a healthy skepticism instead of a mere echo. Links: 1. http://honestnutrition.blogspot.com/2008/01/cnn-false-report-on-dietary-supplement.html 2. http://www.cnn.com/2008/HEALTH/diet.fitness/01/11/hfh.supplements/index.html

Consumer Reports Wrong on Dietary Supplements

CR Wrong on Dietary Supplements By Neil E. Levin, CCN, DANLA Consumer Reports published an article on dietary supplements in January 2008, titled, “Risky Pills – Supplements to avoid”. Unfortunately, CR may have failed to live up to its reputation as an impartial arbiter of quality, apparently relying on its medical and research consultants’ opinions instead of actually testing products. How informed and impartial are these sources on this particular topic? Of course, there is no excuse for companies that blatantly break the law by illegally and knowingly adulterating dietary supplements with drugs or banned substances. The dietary supplement industry asks the FDA and FTC to throw the book at those bad apples pretending to be legitimate businesses. In fact, manufacturers overwhelmingly supported recent legislation – now the law of the land – to put teeth into FDA enforcement powers by banning steroid precursors, regulating manufacturing requirements (cGMPs, current good manufacturing practices) and instituting mandatory reporting of serious adverse events. The supposed burden on the FDA “to prove that a supplement creates “a significant or unreasonable risk” before it can demand its removal” is actually a very low bar, now that the US Supreme Court has allowed a ban on the herb Ephedra without requiring proof that the agency had followed the law, or even its own regulations, in the process. In the CR report, several dietary supplements are singled out for criticism, but with some startling omissions of fact. Androstenedione products (anabolic steroid precursors) have already been outlawed, with the explicit support of the dietary supplement industry. Only rogue manufacturers carry them because they are clearly illegal. Chaparral is mentioned as a present danger, but reputable manufacturers voluntarily withdrew the herb after an FDA warning – back in 1992. Organ and glandular tissues are singled out for risk of Mad Cow disease, but only certain ones are vulnerable and these have largely disappeared from the marketplace. Most glandular tissues are carefully obtained from range-fed animals in New Zealand or Argentina, from areas with no reported cases of this disease. The alkaloid synephrine from Bitter Orange (Citrus aurantium) often gets accused of causing “high blood pressure, heart arrhythmias, heart attack, stroke”. Yet the FDA Medwatch program’s web page does not list a single substantiated complaint of the herb causing these symptoms. Most Bitter Orange is used in formulations along with caffeine and other legal stimulants. In fact, there is evidence that Bitter Orange is not responsible for some of these products’ side effects: “Ephedra-free weight loss supplements have significant cardiovascular stimulant actions, similar to ephedra. These effects are not likely caused by C. aurantium alone, because an eightfold higher dose of synephrine … had no effect on blood pressure, but may be attributable to caffeine and other stimulants in the multi-component formulation.” (The American Journal of Medicine (2005) 118, 998-1003). In 2004, attorney Marc Ullman requested FDA records on Bitter Orange adverse events from the FDA under the Freedom of Information Act. Scrutinizing these files, he found that many so-called adverse events supposedly related to Bitter Orange were actually for unrelated products, combination formulas, pre-existing conditions etc; reporting that, “In its response to the April 14 FOIA, FDA disclosed it had conducted no research whatsoever concerning either the safety or efficacy of Citrus aurantium.” (Natural Products Insider) The American Herbal Products Association also reviewed every adverse event report on Bitter Orange disclosed under another FOIA request and, after eliminating products also containing ephedra and/or caffeine, found only one minor adverse event (weakness, leg swelling) remaining in the FDA archives, which involved a woman also being medicated for osteoarthritis, hypertension, and diabetes. (HerbalGram. 2006;69:52-55) Another study reported that, looking at formulations including Bitter Orange and caffeine with other herbs, “Laboratory testing (including vital signs, serum chemistries, CBC with differential, urinalysis, and electrocardiography) revealed no significant changes.” (Curr. Ther. Res., 60, 145 - 153.) And in another report, “Bitter orange dried-fruit extract did not significantly alter the [heart rate] or blood pressure after a single dose was administered.” (Pharmacotherapy, Dec. 2005) Yet another study reported that bitter orange had no significant effects on any of the cardiovascular variables measured. (Journal of Clinical Pharmacology, 2001;41:1059-63) Another small study reported small increases in these measures, but the point is that strong cautions are premature, at best. One expert has stated that synephrine works differently if synthesized or injected, rather than orally taking the natural herbal extract. (Experimental Biology and Medicine (vol. 229) and Washington Post 9/7/05). There is still reasonable doubt that Bitter Orange supplements have caused any serious adverse events. The herb kava is also the subject of a caution. I personally use this herb, and have looked at the few, unverified reports relating to liver problems and concluded that they are anecdotal and probably unrelated to use of the herb. Some toxicology experts note that the vast majority of such reports are unverified and that “kava extracts continue to demonstrate a far better risk-to-benefit ratio [than medical options].” (Toxicology Letters, Volume 150, Issue 1, 15 April 2004) My routine liver function tests remain optimal. I was surprised that CR touts the “USP Verified” mark, a certification that is not even as stringent and broad-based as the new federal cGMPs, which are mandatory. This explicit endorsement of a commercial testing program that does not yet meet the new national standard seems misplaced, and is also unfair to imply that GMP-certified manufacturers audited by competing certifying agencies have lesser quality controls. I believe that CR has missed the mark in portraying dietary supplements as dangerous and unregulated by using inconclusive, outdated and unrepresentative data. Why doesn’t the magazine to raise its coverage of these issues to the same high standard as its other reporting? Scaring consumers into using more dangerous medical treatments by such methods may sell magazines and gain media exposure, but at the cost of CR’s credibility, consumers’ wallets and real lives lost. Reactions to properly prescribed pharmaceutical drugs reportedly cause over 100,000 deaths per year and may be the fourth leading cause of death in the US; even ignoring medical errors and overdoses. (JAMA, Apr 1998; 279: 1200 - 1205.) Positioning herbs and other dietary supplements as dangerous, when they are rarely life-threatening, is irresponsible and completely disproportional to their relative safety.

Natural Health: Ten Predictions for the Year 2008

Natural Health: Ten Predictions for the Year 2008 By Neil E. Levin, CCN, DANLA 12/10/2007 The New Year will bring more proof of antioxidant benefits for human health. Recent research shows that antioxidants help to maintain healthy brain functions during aging, protect brain and nerve cells, and prevent hormones and cholesterol fractions from oxidizing to become more harmful forms. Look for an expanded understanding of the benefits of these synergistic nutrients in 2008. 2008 will provide more proof of omega-3 fatty acids’ benefits. For example, DHA helps to maintain healthy balances of cholesterol fractions and protects the brain and nerves. EPA helps normalize cell membranes and cellular health. These essential fats are typically very low in the American diet, so dramatic results could occur in clinical trials providing these nutrients to participants. There will be more safety scares regarding popular prescription and Over-The-Counter drugs, creating new safety warnings and label cautions. Since the most popular medications are typically blocking or inhibiting natural body functions (calcium channel blockers, cholesterol production inhibitors, serotonin re-uptake inhibitors, stomach acid production inhibitors, etc.) rather than dealing holistically with the causes of problems that create body imbalances (lack of optimal levels of nutrients, environmental chemicals and metals, chronic stress - lack of deep sleep, low fiber - high carbohydrate diets, etc.), major side effects from such drugs are inevitable. Side effects from pain medications will become more evident, increasing the number of people looking for safer alternatives. Herbs and spices are the major natural alternatives with some scientific evidence of efficacy. The market for organic and local foods will continue to grow at amazing levels. This will put pressure on the regulatory, farm and grocery industries to manage these products and segregate them to maintain their integrity. That contrasts with the increased reliance on genetically engineered corn to produce ethanol that raises food costs and increases the use of farm chemicals. And there is much evidence that non-genetically engineered foods are both environmentally and nutritionally superior to their modified cousins, while natural farming techniques are proving superior to chemical and genetically engineered farming in terms of managing fuel and seed costs, water use, improving both crop yields and selling prices, etc. Millions of farmers around the world have already weaned themselves from the chemical-genetic “green revolution” to use appropriate local farming techniques and have actually been more successful as a direct result of truly “green” practices. America has begun to awaken to the benefits of local and organic foods in terms of freshness, reducing the use of fossil fuels for transportation and demonstrable benefits to local economies. Watch for these trends to accelerate in 2008. Blood pressure and blood sugar concerns will continue to grow, along with a medical backlash attacking natural strategies to manage these concerns. However, science will also continue to amass evidencing the positive health benefits of natural products to help people maintain already healthy blood levels, in contrast with the poor symptom management that is a characteristic of pharmaceutical or surgical interventions used to “correct” chronic biological imbalances. These issues dovetail with current obesity and cardiovascular concerns and are part of the same syndrome related to chronic stress and poor diets. Positive reports of the benefits of higher levels of vitamin D will continue to proliferate, though with some bias against the synthesized vegetarian/vegan form of vitamin D2 versus D3 from fish oil or sheep lanolin. Health authorities will be pressured to raise both the recommended Daily Value and the Upper Limit of vitamin D to five times the current levels. Research will continue to accumulate regarding the health benefits of whole grains and whole foods, as will reports of people allergic or sensitive to gluten, corn, and other grains. More mainstream processed groceries will have whole food options in 2008. This is a good trend, though with cautions for the sensitive minority. There will be continuing claims that “dietary supplements” are illegally contaminated with steroids or other pharmaceutical drugs. These claims will typically be self-serving and defensive, made primarily by athletes accused of cheating by using banned substances. Beyond the obvious fact that legitimate supplement manufacturers do not have illegal substances on hand and that GMP (Good Manufacturing Practices certification) quality manufacturing protocols would avoid inadvertent contamination, these accusations are a barometer of how “unregulated” the mainstream media and the public thinks dietary supplements are. While there are plenty of regulations written specifically to regulate supplements, and even the FDA claims that it has adequate regulatory authority, somehow certain medical authorities and journalists like to pretend otherwise; perhaps to have a handy punching bag to deflect attention from the well-documented hundreds of thousands of deaths caused annually from pharmaceuticals and medical errors. In any case, expect more of this blame game in 2008. With a presidential election campaign under full swing, no meaningful legislation regarding health care or Medicare will be passed in 2008. There will be a narrow window of opportunity for such measures in 2009 with a new Congress and Administration. Natural health advocates will continue to press for meaningful use of nutrition to combat the major causes of disease and illness in America, with probably little impact against the lobbying might of the medical and pharmaceutical interests. The wild card is if, by some miracle, the insurance industry finally notices that their costs could be contained by the use of targeted nutrition such as the use of calcium and vitamin D to prevent osteoporosis, antioxidants to prevent age-related macular degeneration and oxidative-related glaucoma that affect vision and impact seniors’ independence, omega-3 fats to prevent coronary heart disease, the use of fiber to manage healthy cholesterol levels, etc. That could swing the pendulum towards the use of natural products to control healthcare costs. But I’m not betting on it happening in 2008, though I hope that they wise up soon enough to manage the recently overactive increases in medical costs. There will be additional, unjustified health scares about essential nutrients in 2008. Especially beware of “meta-analyses” that mix unrelated studies and magnify the number of variables using often-flawed statistical models. Some probable targets: · Kava (a few unrelated, anecdotal reports of liver problems) · Folic acid (a few reports of higher cancer levels despite a lot of cellular data indicating the opposite, creating a backlash against re-fortification of refined foods) · Vitamin E (continued championing/publicity of questionable meta-analyses over more rigorous blood-level studies will continue the inexplicable controversy over the safety of this essential nutrient that most Americans are reportedly deficient in.) · Beta-Carotene (again, blood level studies and total antioxidant studies repeatedly show its safety, but studies measuring only administration of certain doses to sick populations that may be deficient in antioxidants create a conflicting picture.) · DHEA (this adrenal hormone has been vilified as a “steroid”, but is no more so than vitamin D. No less an authority than physician and US Senator Tom Coburn has sent a letter to his colleagues informing them that he has reviewed the issues and urging them to avoid a ban of this natural product, which is useful in anti-aging strategies but not for bodybuilders. Efforts by leading senators (including presidential candidates Clinton and McCain) to ban DHEA are ongoing.

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/