Federal Dietary Supplement Registry bills

 Dietary Supplement Legislation Misguided & Inflationary

A bill sponsored by Senators Durbin (D-IL) and Braun (R-IN) - S.4090, the Dietary Supplement Listing Act - mandates a registry of all dietary supplements, citing safety concerns. Meanwhile, the Senate Health, Education, Labor, and Pensions (HELP) Committee also added mandatory product registration for this non-drug category to must-pass prescription drug user fee legislation S.4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA). 

These concerns are overblown; the proposed solution draconian. Why treat an overwhelmingly safe food category as inherently dangerous? Multivitamins, vitamin C, calcium, fish oil, and common nutrients are non-toxic, with few safety concerns.

Senator Durbin uses Adverse Event Reports (AERs) as justification. But Mr. Durbin knows AERs are defined as associative, not proof of a causal relationship. I manage a team handling dietary supplement AERs for a responsible manufacturer, which are promptly investigated and reported to the FDA. The few AERs we receive are typically caused by pre-existing conditions/known drug effects, not supplements. And many dietary supplement AERs received by FDA involve multivitamin choking issues, not toxicity. 

There are potential interactions between certain ingredients and certain drugs. A published report of Mayo Clinic patient records identified only five such ingredients, noting only minor negative drug interactions. Statistics from the authoritative American Association of Poison Control Centers confirm zero deaths are associated with dietary supplements most years. Official AERs, not necessarily caused by supplements, showed only 166 hospitalizations and 22 deaths over an 11-year, 4-month period. By contrast, CDC estimates 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths from foodborne diseases each year; food allergies cause 15 million illnesses, 30,000 ER visits and 150–200 deaths. Taking a dietary supplement is statistically far safer than eating a meal. 

If there is a safety issue, FDA already has the power to ban products, as it did with the herb ephedra. Facility registration is already mandated in existing Bioterrorism and Food Safety laws, but S.4090 inexplicably removes carefully designed antiterrorist protections. The National Institutes of Health already have a huge dietary supplement label database, which the FDA seeks to duplicate in a wasteful agency rivalry. 

S.4090 imposes large fines - and jail terms - for not getting advance bureaucratic permission to market any supplement, even vitamin C. Companies must seek registration numbers and identify individuals to be severely penalized for infractions, with sales restricted by agency refusal or delay. Why does the FDA need absolute veto power over every vitamin; adding red tape and inflationary costs? The FDA already has statutory authority to inspect manufacturers, review labels and batch records, and confirm AERs are being properly handled/reported. Since the rationale is lack of enforcement of existing laws, how does piling on new regulations, fees, and harsh penalties solve that persistent agency problem? An analogy: would new laws lowering the speed limit and requiring drivers to keep mileage logs stop speeders, or is enforcement the real solution? 

The dietary supplement industry welcomes reasonable consumer protections. We supported laws giving FDA authority over ingredients, label claims, Good Manufacturing Practices (GMP), facility inspections, food safety practices, facility registration, adverse event reporting, steroid bans, and allergen labeling. We’ve repeatedly lobbied Congress for higher FDA enforcement budgets to weed out bad actors, but oppose universal pre-market approval.

Why is a safe food category – dietary supplements – targeted for harsh regulation and higher costs, strangling innovation and consumer needs? If safety is the issue, why shouldn’t riskier food manufacturers (allergens and food poisoning) also need pre-market approval, their employees targeted for prosecution and fines? This is a punitive bill targeting an overwhelmingly safe product category for no justifiable reason. 

Neil Edward Levin, CCN, DANLA

NOW Health Group

Bloomingdale, Illinois

Supplements vs. Food to Obtain Key Nutrients

Supplements vs Food [Infographic] by the team at Supplement Centre

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

 

Metabolic Syndrome and Nutrients

Metabolic Syndrome is not a disease; it is a cluster of symptoms that are considered risk factors for diabetes and heart disease. These include blood pressure, waist circumference, fasting blood sugar level, triglyceride level, and HDL cholesterol level. If someone has abnormal test results for 3 of these 5 markers, that person may be considered to have metabolic syndrome. It is well established in the medical literature that people with diabetes have higher rates of heart disease and a higher death rate than the general public. Obviously, it is not desirable for any of these metabolic markers to be outside the normal range, and individually they are recognized as risk factors for heart disease and/or diabetes.

Glucose management can be helped by adequate and inhibited by inadequate nutrient intake. Chromium is recognized as essential to managing blood sugar; as is Biotin, which is a B-Complex nutrient that is not one of the essential eight B Vitamins. For herbs, the best evidence is for them helping to maintain insulin sensitivity, control sweet cravings, and perhaps to support healthy pancreatic function: Gymnema sylvestre and Stevia rebaudiana (full spectrum steviosides; not Reb A versions of stevia isolates) appear to help us to manage healthy glucose metabolism; while Banaba leaf extract is a source of corosolic acid, which appears to aid in maintaining healthy insulin sensitivity. Of course, fiber is reported to slow the increase in blood sugar after a meal.

It is far easier to suggest blood sugar supplements and even dietary changes before a drug regimen is started. Afterward, there can be serious interactions, even for fiber. Drastic dietary changes, such as changing to a whole food diet, can be risky if a set dose of medicine is taken because less of the drug may then be needed, opening the door to a real risk of a drug overdose. Patients should always disclose to their physician what supplements they are considering taking to avoid potential interactions. A moderate strength multiple vitamin formula that provides essential levels of chromium is normally allowed by the physician in such circumstances.

Dr. Thomas A. Barringer of Carolinas Medical Center in Charlotte, North Carolina reports that his studies show that multiple vitamins benefit our diabetic population. He states that “any population at risk of having marginally inadequate nutrition, such as the elderly in general, might also benefit." Dr Barringer adds: “all obese people might benefit." He pointed out that supplements are safe and relatively inexpensive, so taking a daily multivitamin is "a reasonable option" for people who are overweight, who have any type of diabetes, who may not receive adequate nutrition or whose immune system is weak. (March 4th 2003 Annals of Internal Medicine)

Dietary supplement manufacturers have one thing that they can tell customers who have diabetes: that they should consult their physician before taking any supplements. Beyond that, vitamin companies should stick to careful descriptions as to how certain products may support blood sugar already within the healthy range by various mechanisms. Going into detail about which supplements show benefit for diabetes, or any disease, is illegal under DSHEA, the Dietary Supplement Health & Education Act.
Alpha Lipoic Acid (ALA) is a potent antioxidant that helps to maintain healthy insulin sensitivity. Insulin resistance occurs from swings in blood sugar due to poor diets high in refined carbohydrates (white flour, white sugar, high fructose corn syrup) that eventually lead to the hormone Insulin becoming ineffective at moving carbohydrates out of the bloodstream into the cells. ALA has the additional benefit of protecting cells from oxidative damage, including liver cells.

Chromium is available in several forms. While some of the current evidence is on the form called chromium picolinate, other forms may be more active in controlling cholesterol, such as chromium nicotinate (polynicotinate) that’s bonded to niacin (Vitamin B3). This mineral helps us to properly manage blood sugar and is a component of Glucose Tolerance Factor. Chromium may also help maintain lean body mass (muscle) during calorie-restricted dieting.

Citrimax® is a fruit extract that helps to limit the liver's production of fat from carbohydrate. Its active compound, HCA (-Hydroxycitric acid), is an extract from the fruit rind of Garcinia cambogia that may help to downregulate the body’s ability to convert carbohydrates into stored fats.

Corosolic acid helps maintain proper insulin sensitivity, allowing sugar to be efficiently moved from the bloodstream into cells.

Gymnema sylvestre improves uptake of glucose into cells, may block ability to taste “sweet” flavors (reducing a sweet tooth), and may be useful for maintaining healthy cholesterol and triglyceride levels.
Stevia extract is a natural herbal product that is non-caloric; in its full-spectrum form providing several steviosides it may support pancreatic function and promote proper insulin sensitivity.

Functional Doses of Vitamins and Minerals for Bones

• Protein: 0.8 grams per kilogram of body weight

• Calcium: Over 1 gram per day

• Magnesium: 310 – 420 mg per day

• Zinc: 15 mg per day

• Copper: 2.5 to 3 mg per day

• Boron: 3 mg per day

• Manganese: 5 mg per day

• Potassium: 3,500 to 4,000 mg per day

• Vitamin D: over 500 IU daily

• Vitamin K: Levels are not well understood; at least 90 mcg/d for women and 120 mcg/d for men

• Vitamin C: over 500 mg daily

• Vitamin A: 2333 IU in women and 3000 IU in men; avoid low and excessive amounts

Palacios C. The role of nutrients in bone health, from A to Z. Crit Rev Food Sci Nutr. 2006;46(8):621-8. Review. PubMed PMID: 17092827.

Nutrients for Heart Health interview

From an interview of me by Whole Foods Magazine, february 2011:

Our aging population will naturally turn to nutrients as a core defense of their heart and cardiovascular (CV) health. Research continues to pile up to support the benefits of various vitamins, minerals, amino acids, herbs, antioxidants, and other dietary supplements to optimize heart health. The trick is to communicate clear benefits associated with specific nutrients and formulas while treading on the right side of the label claims limits.

There are products that support various aspects of CV health. These include circulation, vascular health, heart energetics, fat metabolism, stress and cortisol control targeting abdominal fat, electrolyte metabolism, etc.

Additional heart support could be associated with blood sugar health, since diabetics disproportionately suffer and die from cardiovascular disease. Supporting nutrients to maintain healthy glucose metabolism include alpha lipoic acid, chromium, cinnamon, biotin, Gymnema sylvestre, corosolic acid, and others. The use of stevia as a sweetener can also be helpful in cutting carbohydrate intake; the whole herb, not the “Reb A” fraction commonly sold as a mass market sweetener, also has been shown to have supportive effects on pancreatic function, insulin sensitivity, and antioxidant benefits.

Many isolated nutrients have historically been used to support cardiovascular health, including amino acids (l-arginine, l-citrulline, l-carnitine), lecithin, vitamin E complex, CoQ10, B complex vitamins, methylators like TMG and SAMe, magnesium, antioxidants, plant sterols, sugar cane policosanol, and nattokinase. At the same time there are many botanicals for the same purpose such as hawthorn leaf and flower extract (not the berries, which are not shown to help the heart), and prickly ash bark. Whole foods or botanicals that support heart health include cayenne, garlic, ginger, cayenne, and whole fermented organic red yeast rice. And let’s not forget the benefits of fish oils and fiber, which do have FDA-approved qualified health claims.

Vitamin D also has a role in heart health, a benefit which the Institute of Medicine’s committee that released the new dietary recommendations did not endorse. By contrast, the FDA’s European counterpart EFSA (the European Food Safety Agency) has acknowledged a role for vitamin D in heart health: "The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin D and contribution to the normal function of the immune system and healthy inflammatory response, and maintenance of normal muscle function." The heart, of course, is a muscle; the body’s control of inflammation, calcium metabolism, and muscle function are all intimately related to heart health.

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/

How Nutrition Affects Swine Flu (Influenza) and Immunity

Why are the Public Health authorities silent on the role of nutrition to protect us during an official national health emergency? Do they not know, or simply not care? Is either answer acceptable to citizens concerned about their health and wanting to get practical/real/fair/impartial information that we can utilize to help protect our families? Here's what the experts are not telling us:

• Did you know that if you had the seasonal flu vaccine last year it may make you more vulnerable to the swine flu this year? Vaccines create antibodies that actually make you more susceptible to other organisms, like viruses and bacteria. (Four Canadian studies reported by CBC News, 9/23/09)
• Did you know that side effects of vaccines can be minimized if there are adequate levels of vitamin D in the person? (Epidemic influenza and vitamin D. Epidemiol Infect. 2006 Dec;134(6):1129-40. Review.)
• Did you know that a lack of vitamin D makes people far more likely to have respiratory infections? (On the epidemiology of influenza. Virol J. 2008 Feb 25;5:29. Review.) Did you know that the virus itself can become less aggressive and less prone to mutating into more dangerous forms if a person has adequate levels of nutrients, especially antioxidants? (Host nutritional status: the neglected virulence factor. Trends Microbiol. 2004 Sep;12(9):417-23. Review.)
• Did you know that antioxidants, like selenium, not only reduce our vulnerability to getting influenza but also reduce the chances that it will progress into pneumonia! (Host nutritional status: the neglected virulence factor. Trends Microbiol. 2004 Sep;12(9):417-23. Review.)

Mislabeled Vegan Supplements?

It appears that some vitamin brands are listing their products as Vegan, yet formulating them with vitamin D3 synthesized from Sheep's Lanolin. There is no Vegan source of vitamin D3, which is produced by chemical synthesis when animal fats called sterols are exposed to Ultraviolet light (UVB rays). D3, or cholecalciferol, is always made from animal fat. The other form, vitamin D2, or ergocalciferol, is from a Vegan source; though one has to watch out for animal gelatin stabilizers and microbeads in microencapsulated dry forms, especially. Vegan microencapsulation for dry forms of fat-soluble nutrients including beta-carotene and lutein was only perfected in mid-2005, so it is possible that some products made before then were mislabeled as Vegetarian if the company did not investigate its raw material sources carefully. (Many brands do not manufacture their own vitamin supplements, relying on contract manufacturers to make their outsourced formulas for them. In many cases, the brands do not normally have access to the full ingredient and finished product specifications of the actual manufacturer. This can lead to ignorance and errors when making label claims related to the presence or absence of allergens and animal products.) The D2 form is synthesized from plant sterols exposed to the same kind of light. Plant sterols, by the way, have an FDA-approved health claim that they "may reduce the risk of heart disease" and are considered healthy. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/ucm064919.htm There is also a controversy over whether D3 is much better than D2. D3 is the form found in fish liver oils and is often added to fortify foods such as milk and orange juice. D3 is also the form that we synthesize in our own bodies when cholesterol (that animal sterol aforementioned) is exposed to UVB rays. D2 is likewise made by plants when their oils (plant sterols, or phytosterols) are exposed to UVB light. In modern studies, both forms are equally well absorbed and both are good at preventing rickets and maintaining bone mass. Both forms equally maintain the level of the active compound serum 25(OH)D3 levels. "Therefore, vitamin D2 is equally as effective as vitamin D3 in maintaining 25-hydroxyvitamin D status." http://www.sciencedaily.com/releases/2008/01/080102122306.htm It appears that D3 tests better than D2 in an occasional dosing schedule, like if you got it once a month from a doctor's office. But the assay is apparently flawed and is now known to not measure D2 very well, underestimating its circulating level. For everyday supplementation and fortification, both forms work equally well by all current measures. Some brands with "cultured" or "fermented" ingredients apparently believe that adding lanolin-sourced vitamin D3 to a yeast culture, then drying the whole thing and using it to make vitamins, somehow transmutes the animal fat form of the vitamin into a Vegan-friendly ingredient. They say that the yeast consumes the lanolin-derived vitamin and that the yeast is Vegan no matter what it is fed. But they present no evidence that yeast consumes vitamin D or changes it in any way. Quite the contrary; they brag about providing vitamin D3 – a known animal product - in a supposedly Vegan supplement. This indicates that they know that the form is not changed in any significant way by the yeast culture. One major brand, when asked by me only today, said that they do not disclose their D3 source for their vitamin labeled as Vegan because the source is both "irrelevant" and "proprietary". In other words, they won't tell us and we don't need to know. That pisses me off, pardon me for taking this apparent contempt for Vegans personally. I am not a Vegan but have been a vegetarian since 1972. I do not eat any type of flesh; avoiding not only all forms of meat but also animal broths, gelatin and leather. I scrutinize labels to assure that I am getting no animal products except for dairy, eggs, and honey. Now the Honest Nutritionist in me wants to sound the alarm that some companies are using animal products like gelatin and lanolin in their Vegan-claimed dietary supplements. Whether it's an honest (though sloppy) mistake or a deliberate attempt to have their cake and eat it too is hard to say for sure, but either way this is not fair to Vegans. I tend to fear the worst since they claim the supposedly superior and more popular D3 form in a product whose label also appeals to Vegans and Vegetarians who are being led to erroneously believe that there is now a Vegan-friendly source of D3. There isn't. It is just not true. We are being misled. D3 is not Vegan. D2 is, and is not a bad form as some try to claim. Some medical experts even want to routinely fortify the food supply with D3 because of the largely mythical superiority of that form; that would deprive all Vegetarians and Vegans of their right to avoid hidden animal products in our food. I believe that we have a fundamental right to select our diets based on individual religious, ethical, and cultural beliefs. It is wrong for a corporation to take that right away from us by incorrectly labeling their products that are marketed to Vegetarians and marked as Vegan. Mislabeled products are considered to be adulterated. Obviously, there is no safety issue here and it does not seem as if this matter has attracted much attention, as of yet. But these jokers have attracted my attention and I think that they deserve to get grassroots attention to their attempt to sell non-Vegetarian products to Vegetarians and Vegans. I am not naming names here but will not buy products made by any companies which suggest that animal-source D3 can ethically be sold to Vegans. If you are of the Vegetarian or Vegan persuasion, please check your product labels. If I see vitamin D3 in a product labeled as Vegetarian, I’d feel free to return it to the store as a mislabeled product and get my money back. Vote with your dollars and read product labels carefully before buying anything. If enough people do this, the companies with questionable products will have to deal with a lot of returns from unhappy customers and stores, combined with a drop in sales. Eventually, they will be forced to either correct their labels or change their formulas.

Nutrients of interest to stroke victims

Sorry there's not much detail but this is a list that I made of nutrients that may be useful for someone who has had a stroke. I would suggest that you look each one up at a reputable online database, if interested. Of course, there are often difficulties at getting stroke survivors to take nutritional pills/caps; everything from swallowing to drug interactions. In no particular order: Vinpocetine Pycnogenol Nattokinase Rosemary Thyme Proline CoQ10 Phosphatidyl Choline Acetyl-l-carnitine vitamin E (all 8 tocopherols and tocotrienols) alpha-lipoic acid silymarin magnesium acetylcholine precursors: choline, PC, B5, huperzine

testing dietary supplements

My experience with dietary supplements is that analysis of products with multiple ingredients, especially those at low concentrations, is very difficult and requires experience with the particular supplement matrix (formula plus excipients). Random testing of products off the shelf is fraught with technical difficulties. In addition, many ingredients lack standard, universally accepted testing methods within a dietary supplement matrix, which can result in confusion. These are sophisticated issues, whose resolution sometimes is difficult for anyone trying to ascertain product quality based on limited testing and lack of relevant experience. That is why most labs prefer to test single ingredient products, a tacit admission of the uncertainties involved in testing complex formulations. Testing is not as black and white as news releases often indicate or imply. Further, extrapolation of analytical results to nutrition, health and safety issues also requires expertise in these sometimes controversial areas, which very few labs have. It is important to verify label claims, but sometimes the manufacturer's validated procedures for qualification of an individual ingredient - combined with appropriate quality controls to assure that a proper mixture has been made - may more accurately represent the quality and quantity of that ingredient in a formula than any lab results obtained by applying a single analytical test to vastly different formulations containing that ingredient.

Cardiovascular Health

Cardiovascular Health By Neil E. Levin, CCN, DANLA For a healthy cardiovascular system it is important to get plenty of nutrients over the whole range. B-Vitamins, for example, help to produce energy and to control metabolic processing, including the one that results in excessive levels of the inflammatory compound homocysteine. Homocysteine is a greater risk factor for cardiovascular risk than total cholesterol level. Antioxidants support each other, and clinical research indicates that total antioxidant status is more important than a single level of a single antioxidant nutrient. Antioxidants protect cholesterol from oxidizing, and also protect arterial surfaces from being damaged, leading to plaque formation and cholesterol “patches”. Minerals are also useful for cholesterol metabolism - especially chromium - also calcium, copper, and possibly magnesium and selenium. With the recent stories about obese children – some with Type-2 “adult-onset” diabetes - and with kids getting heart attacks in their teens, there is a growing awareness that cardiovascular health issues are not limited to middle aged men. Recent reports also point to the increased risk for women after menopause or who are on hormone replacement drugs, hammering the point home that age and gender are no longer rigid dividers of people into cardiovascular risk groups. That’s not to say that everyone is aware of these cardiovascular risk factors, but the risk categories in terms of age have certainly broadened dramatically in recent years. We have seen an increasing number of college-aged young men be afflicted by cardiac events at sports or training events, with some dying. Still, the risks do not seem as immediate to young adults with their heightened sense of immortality, especially young men. By the time men hit their 40s, there is an increased awareness of cardiac risks that keeps increasing throughout their lives. The young are mostly oblivious to health risks unless some event creates the beginnings of awareness that they may be at risk, such as a close relative suffering a cardiac event at an early age or a health scare. Unfortunately, these events seem to be increasing. Genetics, sedentary lifestyles, poor diet and obesity all make people susceptible to vascular problems. The emergence of hemorrhoids or any hint of varicose veins should be obvious indications of cardiovascular weakness at any age. Obesity and lack of stamina are also good indicators. Family health history is another consideration that should affect awareness. Circulation depends on body movement/exercise and requires an unobstructed blood flow through flexible blood vessels that have structural integrity. Collagen, elastin and supporting nutrients (proline, lysine, Vitamin C, Pycnogenol®, rutin) help to strengthen these tissues, while certain herbs (cayenne, garlic, horse chestnut, prickly ash extract, hawthorn extract) help to improve blood flow. Smoking and stress narrow the blood vessels, increasing the risk of forming clots or obstructions. Certain amino acids in the diet (arginine, citrulline) support NO (nitric oxide) formation that dilates blood vessels to reduce blood pressure and enhance blood flow to the peripheries. The presence of these components and modulators in the diet help to maintain cardiovascular health and vascular integrity. People should be eating a variety of fruits and vegetables, along with whole grains, in order to provide nutrients essential to the integrity of blood vessels. Products include beta sistosterol, vitamin C, Vitamin E, chromium, garlic, guar gum, Guggul extract, tocotrienols, policosanol, vitamins B1, B6, folate, B12, iodine, magnesium, selenium, potassium, carnitine, ginger, cayenne, hawthorn extract, CoQ10, lipoic acid, homocysteine regulators (B6, B12, folate, TMG), Policosanol, Red Yeast Rice Extract (plain or with CoQ10, alpha lipoic acid and silymarin), prickly ash extract, horse chestnut extract, butcher’s broom extract, grape seed extract, Pycnogenol® and rutin. However, other products are also helpful for cardiovascular health including gamma and delta tocotrienols, amino acids (taurine, carnitine, lysine, proline), Nattokinase (fibrin enzyme for supporting the body’s control of clotting), fish oil, and lecithin. Remember, you must take care of your heart and cardiovascular system if you expect them to take care of you for a lifetime!

Myths about stearate "risks"

There are some common myths about stearates. Please allow me to describe the stearates that are utilized in making nutritional supplements, and how they are used, and other pertinent information on their safety and use in dietary supplements and foods.

Stearic acid is converted into oleic acid in vivo, so becomes a similar fat as is found in olive oil. In fact, one jumbo olive is estimated to contain 13 milligrams (.013 g) of stearic acid (C 18:0), many times more than is used in any pills or capsules. http://www.oliveoilsource.com/olivechemistry.htm

“Stearic acid is well absorbed by the gut and is transported in chylomicrons and remnant particles before being picked up by the liver. Once there, an interesting paradox occurs in that excess stearic acid is simply converted to the 18-carbon monounsaturated oleic acid via a desaturase enzyme in the liver (3) and then recirculates in lipoprotein complexes as oleic acid, which is not hypercholesterolemic. Thus, conversion to oleic acid may explain why stearic acid does not elevate plasma cholesterol concentrations.”

Supplement manufacturers rarely use more than 2% and usually far less or none at all, even though common foods contain much more (beef fat is 19% stearates; cocoa butter is 30%) and stearates are Generally Recognized As Safe (GRAS). It is unusual that they would use more than1-2% in a product, and when they do use them it is typically used in microgram amounts to help process only sticky or non-flowing materials.

The hydrogenation process is not used for the stearic acid in the magnesium stearate. It is possible to convert oleic acid to stearic acid by hydrogenation, but that is not necessary (or desirable) with sources that are already high in stearic acid and low in oleic acid. Lipase-catalyzed interesterification is a viable alternative to hydrogenation these days, for example, if one were to want to convert oleic acid to stearic acid.

No consumer should be inhaling stearates, so the issue of being hazardous is also a bogus one that should be relegated to producers and manufacturers. You can actually say far worse about the hazards of inhaled enzymes, for example. Most supplement materials have MSDS handling sheets that mention the dangers of inhalation. There are no known significant dangers from normal oral consumption or skin contact.

The reason dietary stearic acid is considered benign is based on its failure to elevate plasma cholesterol concentrations (1, 2). Foods naturally rich in stearic acid and other saturated fats include: Red meat (beef, pork, or lamb) High-fat dairy products (whole milk, cheese, butter, and ice cream) Chocolate, Lard, Coconut oil.

For more on stearates, please see: http://www.nowfoods.com/index.php?action=itemdetail&item_id=93528.

Also, the accompanying chart has the percentages of stearic acid in common foods (4). As you can see, stearic acid is far more abundant in olive oil, butter and lard than in dietary supplements as a percentage, with grams in foods and micrograms (possible low milligram levels) in only certain dietary supplements:

A common reference is to a 1990 study in the journal Immunology, but the reference is hardly satisfactory as a demonstration of the alleged harm of stearic acid. This was a test tube study that has not been replicated in living beings, with an artificial situation providing high concentrations of stearic acid exposed to isolated immune cells for hours at a time. It was actually done as a way to investigate whether prolonged high dose stearic acid administration could possibly be used to suppress the immune system for an autoimmune disease treatment. (5) It was definitely NOT a demonstration that this would work the same way with dietary supplements or with foods containing stearic acid. The effect was dose- and time- dependent; with a sustained, prolonged exposure over an 8-hour period that is impossible to replicate in the living human body. For a test tube study, it would first have to be shown that the mechanism was valid in vivo before it could be considered reasonable to extrapolate it to actual living organsms. This study did not do that; nor has any other, to date.

In conclusion, since this mechanism has not been proven in humans or had additional verifying studies, since humans have much more complex metabolic activities, since stearic acid is easily absorbed from the gut and then readily converted to oleic acid in the liver (in vivo), since manufacturers use far less than this study gave and with only a brief exposure, and since people get stearic acid in many common oil-containing foods in far greater amounts than are used in dietary supplements, I conclude that the fears about the use of stearates in dietary supplements are unproven and speculative at best, slanderous and unscientific at worst.

For a second opinion, please see the website of Ray Sahelian, M.D. at http://www.raysahelian.com/magnesiumstearate.html

REFERENCES
1. Yu S, Derr J, Etherton TD, Kris-Etherton PM. Plasma cholesterolpredictive equations demonstrate that stearic acid is neutral and monounsaturated fatty acids are hypocholesterolemic. Am J Clin Nutr 1995;61:1129–39.
2. Aro A, Jauhiainen M, Partanen R, Salminen I, Mutanen M. Stearic acid, trans fatty acids, and dairy fat: effects on serum and lipoprotein lipids, apolipoproteins, lipoprotein(a), and lipid transfer proteins in healthy subjects. Am J Clin Nutr 1997;65:1419–26.
3. Lin DS, Connor WE, Spenler CW. Are dietary saturated, monounsaturated, and polyunsaturated fatty acids deposited to the same extent in adipose tissue of rabbits? Am J Clin Nutr 1993;58:174–9.
4. http://www.nebeef.org/post/lfu/Stearic_Acid.pdf
5. Tebby PW, Buttke TM. Molecular Basis for the Immunosuppresive Action of stearic acid on T Cells. Immunology. 1990;70:379-384.

The Relative Safety of Natural Products

Some have stated that the dietary supplement industry is largely “unregulated”. My response: This is not really a fair statement considering that recent regulatory efforts – supported by that same industry – have clamped down on the industry’s freedom to operate outside the regulatory system. Drug and dietary supplement regulation are becoming more and more similar, though the safety records of the two types of products are remarkably distinct. The dietary supplement industry is now largely regulated, with more and more regulations closing the gaps. Indeed, the industry strongly supported the law to ban steroid precursors from being sold as dietary supplements, making all such products illegal drugs. And the 2006 passage of a law to require all serious adverse events to be reported to MedWatch within 3 weeks – now in effect - is an appropriate method of monitoring safety and determining problem areas needing increased monitoring or official action; though we should not confuse raw AERs with actual evidence of causes-and-effects. The implementation of the long-delayed current good manufacturing practices (cGMP) regulations (that were actually authorized by the oft-maligned DSHEA law in 1994) now requires all supplement manufacturers to be cGMP compliant over the next two years, but with the largest manufacturers required to follow that standard no later than this coming June (2008). cGMP regulations are forcing manufacturers to have quality controls on raw materials and finished goods throughout the manufacturing process, including identity and safety testing. The FDA already prohibits all adulterated products, and has in fact used its authority to act against known offenders, as noted by the agency itself. 2. There are claims that “the Institute of Medicine and the Food and Drug Administration have found that supplement health claims are largely unsupported”. My response: The FDA clearly regulates supplement label claims and requires manufacturers to submit all label claims and maintain proper documentation. The agency apparently does not review this information unless there is a problem; meanwhile making manufacturers submit such information to it while requiring a contradictory label disclaimer that the FDA has not reviewed the claims. I guess that’s what’s called “plausible deniability”. However, the vast majority of responsible manufacturers are careful to present adequate documentation to the FDA, and the cGMP regulations require well-documented justification of all processes, including the writing of label claims. DSHEA requires preapproval of all new dietary supplement ingredients with an eye to proving safety, though manufacturers are allowed to use existing ingredients if they first submit their new label claims to the agency. All new drugs need pre-approval, as do all new supplement ingredients, but drugs are approved for specific uses (though often used for other unapproved “off label” conditions) while supplements are not allowed to make any disease claims, with very few exceptions for FDA-approved health claims. (http://www.cfsan.fda.gov/~dms/supplmnt.html) 3. Some physicians warn that “supplement use can be associated with death”. My response: Supplements, foods and drugs are all associated with death risks, with supplements statistically being the safest of them all, by far. Some have chosen to focus on a very few cases of dietary supplements possibly linked to deaths, but other readers have mentioned the very large death toll from both properly prescribed drugs and drug errors as a way to counter the thinking that drugs are somehow more tightly regulated, and thus presumably safer, than dietary supplements. I agree. In the annals of our peer-reviewed literature, dietary supplements are rarely responsible for accidental deaths other than by illegal adulteration, making this class of products far safer than less-regulated foods or even more regulated drugs. And, just as in the case of prescription drugs, the FDA does not test for purity and safety. Regulators routinely require industries to have quality controls in place to do such testing themselves, with penalties for non-compliant products that come to the attention of the regulatory agencies. And it is appropriate that regulators focus on the products with the most potential to cause injuries, illnesses and deaths. The routine collection of serious AERs will serve to focus the regulators on problem areas. (For more discussion and literature citations, see #6 below.) 4. There are claims that “We cannot easily know” what’s really in supplements. My response: cGMP manufacturers must test their ingredients, so responsible manufacturers do not allow the use of adulterated ingredients and have means to avoid them. It is likely that the adulterant in this case was deliberately added to ensure a noticeable effect. By definition, an adulterated supplement actually becomes an unlabeled illegal drug, not a dietary supplement. There are already penalties for such adulteration under current regulations, and the FDA has forcefully removed these products from the market. The solution is for cautious consumers to purchase their dietary supplements from responsible brands that have third-party quality certifications, and it is likely that only those individuals seeking foolish shortcuts will be involved with mail order brands of questionable integrity. The vast majority of supplement manufacturers wish to promote natural health and will not risk their companies on such questionable unlawful schemes. 5. Regarding the relative use of pharmaceutical drugs (OTC and prescription) versus dietary supplements, related to a comment that fewer people use supplements and that explains their apparently greater safety compared with drugs: My response: A recent survey reports that, “43 percent of Americans say they take a daily multi-vitamin for cancer protection. 21 percent take some other form of nutritional or dietary supplement.” (http://www.icrsurvey.com/Study.aspx?f=Supplement_survey_release.html) This indicates that a majority of Americans, about 2/3, take dietary supplements. In the case of prescription drugs, about 45% of Americans take a prescription, with the percentage rising sharply with age. (http://www.cdc.gov/nchs/fastats/drugs.htm) And Americans also take non-prescription OTC drugs, with a combined rate of drug use estimated at about 2/3 of all Americans...about the same percentage of the population as uses dietary supplements. So the argument that the use rates are sharply different is not substantiated by the data, meaning that the dramatically lower death and adverse event rates for dietary supplements are indeed a valid testimony to their relative safety versus drugs. 6. Some have commented that just because something is "natural" doesn't mean it's safe. My response: There are no foods or dietary supplements that are unregulated by the FDA, and most natural products are far safer than artificial ones. Most synthetic substances, including drugs, have a far greater risk of side effects and deaths in the clinical literature. Still, we make choices every day and do not stop consuming most foods, drugs or supplements because most have such a tremendous reward-to-risk ratio. We obviously can’t stop eating. And since our diets are known to be deficient in essential nutrients, dietary supplements do have an important role to play in ensuring adequate nutrition. (Nutrition and Your Health: Dietary Guidelines for Americans. USDA. 2005. also Fairfield KM, Fletcher RH. Vitamins for chronic disease prevention in adults: scientific review. JAMA. 2002 Jun 19;287(23):3116-26. Review. Erratum in: JAMA 2002 Oct 9;288(14):1720. PMID: 12069675) It was reported in JAMA that, “Most people do not consume an optimal amount of all vitamins by diet alone. Pending strong evidence of effectiveness from randomized trials, it appears prudent for all adults to take vitamin supplements.” (Fairfield KM, Fletcher RH. Vitamins for Chronic Disease Prevention in Adults: clinical applications. JAMA. 2002;287:3127-3129.) Regarding food safety, a medical journal report concluded that, “We estimate that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year.” (Mead PS, et al. Food-related illness and death in the United States. Emerg Infect Dis. 1999 Sep-Oct;5(5):607-25. Review. PMID: 10511517). This indicates that eating food is a far riskier activity than taking dietary supplements, since the risk for the 2/3 of food eaters that are also supplement takers is literally orders of magnitude lower than 2/3 of the known risk of eating food (which everyone does). There are few human activities with lower odds of causing death or serious illness than taking dietary supplements. In fact, even lipsticks and cosmetics are typically responsible for more annual accidental deaths than vitamins. Looking at the categories of deaths reported by the American Association of Poison Control Centers from 2002-2004, only 5 accidental deaths were reported linked to dietary supplements, 7 from cosmetics and personal care items, over 600 related to acetaminophen use, 117 related to aspirin use, and 66 from ordinary household cleaners. By far, dietary supplements are probably the safest category of products that we put into our mouths, and are demonstrably getting safer with the new regulations now being implemented. 7. Let’s talk about the real dangers of drugs, which exceed the risks of supplementation by mind-boggling amounts. That is the main reason why drugs are controlled substances. A JAMA report documented the large death toll for properly prescribed drugs: “We estimated that in 1994 overall 2,216,000 (1,721,000-2,711,000) hospitalized patients had serious ADRs and 106,000 (76,000-137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.” (Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. PMID: 9555760) Also, the 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: "At least 1.5 million Americans are sickened, injured or killed each year by errors in prescribing, dispensing and taking medications, the influential Institute of Medicine concluded in a major report released yesterday. Mistakes in giving drugs are so prevalent in hospitals that, on average, a patient will be subjected to a medication error each day he or she occupies a hospital bed, the report by a panel of experts said. Following up on its influential 2000 report on medical errors of all kinds, the institute, a branch of the National Academies, undertook the most extensive study ever of medication errors in response to a request made by Congress in 2003 when it passed the Medicare Modernization Act. The report found errors to be not only harmful and widespread, but very costly as well. The extra expense of treating drug-related injuries occurring in hospitals alone was estimated conservatively to be $3.5 billion a year." Prescription drugs were named as one of the largest causes of American deaths, perhaps the second largest, as noted in another report by CDC, also published in JAMA: "IN 2004, POISONING WAS SECOND ONLY to motor-vehicle rashes as a cause of death from unintentional injury in the United States. Nearly all poisoning deaths in the United States are attributed to drugs, and most drug poisonings result from the abuse of prescription and illegal drugs. Previous reports have indicated a substantial increase in unintentional poisoning mortality during the 1980s and 1990s. To further examine this trend, CDC analyzed the most current data from the National Vital Statistics System. This report summarizes the results of that analysis, which determined that poisoning mortality rates in the United States increased each year from 1999 to 2004, rising 62.5% during the 5-year period." (FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION: Unintentional Poisoning Deaths—United States, 1999-2004. JAMA, March 28, 2007; 297: 1309 - 1311.) As you see, the fuss about dietary supplement safety is in reality a tempest in a teapot, as the risks of eating normal foods and using pharmaceuticals are each far more dangerous, in turn. This is not to minimize the need for strict controls of dietary supplements…but to a large degree, these controls already exist or are currently being implemented. Enforcement has been slowly tightening over the past 15 years. But, looking at these authoritative death and injury statistics, is anyone really surprised that the FDA properly chooses to focus its enforcement actions on products that are proven to be dramatically more dangerous to public health than dietary supplements? Some form of triage is appropriate, given the large number of deaths and injuries from food and drugs. But dietary supplements generally do not significantly contribute to these risks, and therefore do not deserve to be singled out as especially dangerous when they are comparatively very safe. Neil E. Levin, CCN, DANLA

What is pharmaceutical grade (USP)?

The US Pharmacopeia (USP) publishes official monographs for certain substances. These monographs include specific assay methods and product specifications to assure identity and potency. Material that is tested by these methods to meet those specifications is then eligible to be called pharmaceutical grade, or USP. The key concept is "standards and verification" http://www.usp.org/aboutUSP/ Many natural ingredients do not have published USP monographs, so cannot be called USP grade (as there are no USP specifications or standards to test against). Also, the testing is often a bit imprecise, so a test result for purity may be acceptable within a narrow range (from 98% - 101% of label potency, for example) and still be considered good. Another standard monograph is that found in the Food Chemicals Codex, desribing FCC food grade materials. A product with an FCC monograph can be tested to meet the food grade specifications that are typically less rigorous than those in a pharmaceutical monograph, but do provide standards for purity and identity. http://www.usp.org/fcc/ Some substances have both USP and FCC monographs and can claim both grades. For example, the amino acid l-arginine has monographs in both compendia, as do some other aminos.

Should cancer patients take vitamins?

Regarding the article “Should cancer survivors take supplements?” (14:34 ET, Thu 21 Feb 2008, http://features.us.reuters.com/wellbeing/news/FA7141DA-E0B3-11DC-91C7-1D7C8A14.html), I had written a rebuttal to a letter in CA: the Journal of the American Cancer Society, addressing these issues. (1) It is available on the journal’s web page, posted after editorial review. I cite numerous studies in which dietary supplements were used with cancer therapies, with no apparent problems. Additionally, since 40% of cancer patients actually die of malnutrition, please consider that it is wise to try to devise strategies to nourish the patients…they can’t live solely on chemotherapy and radiation, or surgery. Soon after, a review article addressed the same issue, reaching a similar conclusion: it is possible to mix dietary supplements with cancer therapies, in many cases improving results, though the timing is important. “CONCLUSION: None of the trials reported evidence of significant decreases in efficacy from antioxidant supplementation during chemotherapy. Many of the studies indicated that antioxidant supplementation resulted in either increased survival times, increased tumor responses, or both, as well as fewer toxicities than controls; however, lack of adequate statistical power was a consistent limitation.” (2) Science Daily reported that, “There is no evidence that antioxidant supplements interfere with the therapeutic effects of chemotherapy agents, according to a recent systematic review of the use of antioxidants during chemotherapy, available in the May, 2007 issue of the peer-reviewed journal Cancer Treatment Reviews. In fact, they may help increase survival rates, tumor response, and the patient’s ability to tolerate treatment.” (3) REFERENCES: 1. Cancer patients may very well tolerate the use of certain dietary supplements http://caonline.amcancersoc.org/cgi/eletters/55/5/319#176 2. Block KI, et al. Impact of antioxidant supplementation on chemotherapeutic efficacy: a systematic review of the evidence from randomized controlled trials. Cancer Treat Rev. 2007 Aug;33(5):407-18. Epub 2007 Mar 23. Review. PMID: 17367938 [PubMed - indexed for MEDLINE] 3. Antioxidants May Aid Chemotherapy Patients. ScienceDaily. Retrieved February 22, 2008, from http://www.sciencedaily.com/releases/2007/04/070426132954.htm Neil E. Levin, CCN, DANLA http://www.honestnutrition.com/

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

My second letter to Reader's Digest about vitamins

Subject: Re: Vitamin Hoax Thank you for your reply. But your statement that "supplements are unregulated" is completely untrue, and is contradicted by the FDA itself on its own official Web page [“FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter).”]. Are your experts completely unfamiliar with the Dietary Supplement Health and Education Act prohibiting new dietary ingredients without FDA pre-approval and regulating adulterated products and label claims, the Serious Adverse Event reporting act passed last year, the mandatory federal current Good Manufacturing Practices (cGMP) that are now being implemented requiring quality controls and identity testing of ingredients, and currently operational GMP-audited manufacturers? That inflammatory falsehood is exactly the kind of media myth that evidences bias or abject misunderstanding. You have represented a misguided opinion as fact, when it is clearly contradicted by official records of the FDA, FTC and the Congressional Record in both law and regulations. As a watchdog for clinical studies that are misrepresented or poorly done, it is obvious to me that your writers cherry-picked negative studies that were heavily criticized, some contradicted by more robust data or not able to be replicated, and some done with very sick people where the results were admittedly not applicable to healthy populations. Many scientists simply fail to understand the topic of nutrition, thinking that nutrients should be taken just like drugs: in isolation and in high potencies to treat disease in their studies. That is pharmaceutical medicine, not basic human nutrition, which is an all-too-common mistake that creates a lot of confusion when applied to the moderate dietary supplements used by ordinary people to enhance their vitamin-starved modern diets. Using examples of potential side effects from taking amounts far above commonly available supplement potencies as the main reason to avoid taking them entirely is intellectually dishonest, in my opinion, when no one was actually suggesting that everyone take those mega dose amounts in the first place. When you say that, “Food (especially locally farmed food) is the only way to get your vitamins that's absolutely proven to be safe and effective”, you are only partially right. I am a nominee to the Illinois Local and Organic Food Task Force, on a slate approved by the state Department of Agriculture, so I do understand your point and empathize. But you forget the tens of thousands of people affected annually by food poisoning. This makes vitamins orders of magnitude safer than food, especially fresh foods, and are thus more deserving of your praise for safety and efficacy. You also seem to forget that vitamins are regulated as a special, highly regulated food category by the federal government (by law), and not as drugs. If it is so 'easy' to "get what you need from food" then why does your own report admit that only 3% of us get the minimal nutrient levels from our diet? That really disproves this tired old mantra, doesn't it? It is pure institutional bias that prevents the NIH from recommending multiple vitamins, when even the mainstream medical journal JAMA has done so years ago. If you remember (I do), it took the federal government 20+ years to endorse the use of folic acid to fortify foods denatured of that essential vitamin, during which entire time the evidence was already strong that it could prevent birth defects; with a request in to the Nixon administration that it was time to take action. The March of Dimes recommended this fortification long before the government finally caved in (during the Clinton administration!), but meanwhile thousands of children were born each year with potentially preventable and predictable birth defects while waiting for the perpetually elusive 'more conclusive evidence'. But there never seems to be enough evidence when we're talking about dietary supplements. Even a multiple vitamin taken by the mothers should have been enough to spare these children, but the government still to this day won't fully act to protect people's health by recommending that the 97% of us not eating even minimally right take a simple and safe daily multivitamin, as many doctors already recommend. Are we so set on forcing people to eat right, when they clearly won't, that we should all just pretend that taking a multivitamin as nutritional 'insurance' is somehow fundamentally wrong? In good conscience, I can't do that. I know better. And so do most Americans, who have opted to take vitamins and do so without much risk. Perhaps you haven’t noticed the reports that our food supply has dramatically dropped in nutritional value over the past half century due to factors such as chemical farming, less nutritious plant varieties, changes in storage and handling, etc? The nutritional content of U.S. fruits and vegetables has declined over the past 50 years, according to a researcher at the University of Texas. Cited in an article by Scripps Howard News Service, biochemist Donald Davis said that of 13 major nutrients in fruits and vegetables tracked by the Agriculture Department from 1950 to 1999, six (protein, calcium, phosphorus, iron, riboflavin and vitamin C) all showed noticeable declines. Declines ranged from 6% for protein, 20% for vitamin C, and 38% for riboflavin. [February 2006, official meeting of the American Association for the Advancement of Science in St. Louis, MO] Data from the Department for the Environment, Food and Rural Affairs (DEFRA) showed that, between 1940 and 1991, trace minerals in UK fruits and vegetables fell by up to 76 per cent, and United States Department of Agriculture (USDA) figures showed similar declines. [McCance and Widdowson 1940–1991, The Composition of Foods, 1st to 5th editions, published by MAFF/RSC] [Mayer AM, 1997, ‘Historical changes in the mineral content of fruits and vegetables’, in Lockeretz W (ed.), Agricultural Production and Nutrition, Tufts University School of Nutrition Science and Policy, Boston, MA, p 69–77. See also British Food Journal 99(6), p207–211] [Bergner P, 1997, The Healing Power of Minerals, Special Nutrients and Trace Elements, Prima Publishing, Rocklin, CA, p 312] Neil E. Levin, CCN, DANLA www.honestnutrition.com

OCA Nutri-con Campaign Full of Errors

Dear OCA (Organic Consumers Association), I am personally concerned about the misleading and inaccurate statements made regarding the OCA’s Nutri-Con program (http://organicconsumers.org/nutricon.cfm). The lack of accurate scientifically valid information and the application of misleading science within inappropriate examples will only serve to put the whole program in a questionable light. Don’t get me wrong, it is preferable to get nutrients from food. But as government studies have shown that up to 95% of the public suffer from deficiencies below RDA levels of vitamins and minerals (not the 99% stated in your article), it is important to have a cost-effective and simple means to correct nutrient deficiencies and enhance healthy homeostasis. Ten of thousands of scientific studies have shown that the common forms of nutrients used in today’s dietary supplements are safe, suitable and effective for this purpose. Your web page seems to promote specific brands, which calls the integrity of the information into question. For example, Neo-Life is touted as good and other brands seem to be bad. You post an article taking us to a commercial webpage (http://www.nutriteam.com/natural.htm) Why are explicit commercial endorsements being made? Here are some specific problems with the accuracy of the information: Synthetic vitamins: This term is misleading unless you are speaking about vitamins with separate natural and synthetic forms, like alpha tocopherol (vitamin E). For most other vitamins the term is meaningless because most synthesized B vitamins (many are actually naturally grown by a fermentation process) are identical to the forms found in food. This is called a natural form or a nature-identical form. When a vitamin is synthesized, it is not called a synthetic form unless it is chemically/structurally different from the natural form. You will only cause confusion if you refuse to follow this important distinction that is essential to a common understanding of chemistry and biology. You simply should not just make up terms for nutrient forms that are confusing to scientists and laypersons alike. Your terminology should be true and accurate and not likely to confuse the reader; but so far, I fear that you have failed to accomplish this. The author claims that “synthetic” vitamins cause disease. Please provide some real proof. I have read hundreds of studies to the contrary and toxicology records also indicate a good margin of safety for conventional vitamins. To claim that a synthesized nature-identical B vitamin produced by fermentation will provoke the same immune reaction as an invasive organism is simply incredible (as in not credible). He also claims, “Certain studies on natural vs. synthetic vitamins have shown that synthetic vitamins are 50 to 70% less biologically active than natural vitamins,” without making it obvious that he is only referring to vitamin E, which is the only one that has a “dl” form, not to other vitamins. I see it as intellectually dishonest to falsely imply that all synthesized vitamins share this problem. Regarding beta carotene: Your statement: “It's no wonder that some of the testing done with the synthetic form of beta-carotene has produced mixed results, and in one study on smokers, produced a negative result.” In fact, the problems with beta carotene were largely the result of other confounding factors and poor science, not the synthetic production of the nature-identical pro-vitamin. I certainly prefer the complexes to the isolates, but the fact is that the beta carotene molecule itself is the same exact form and molecule, whether produced from food or by synthesis. It is actually the presence or absence of total antioxidants that is the determining factor for people’s health in these studies. Some years ago an antioxidant study in Finland was halted early because of a widely reported increase in cancer rates among male smokers taking beta-carotene. (1) Headlines associated this supplement with cancer risk. Despite objections that the study was flawed, beta-carotene use dropped. A later analysis published in July 2004 took another look at that exact same Finnish smokers' study data, but now taking into account total antioxidant intake, which cleared away the scientific controversy. The smokers’ risk of getting lung cancer was inversely associated with total antioxidants in the diet, with more total antioxidants meaning fewer cancers. (2) A composite antioxidant index was generated for each of the 27,000 men over 14 years. The calculated amounts of carotenoids, flavonoids, Vitamin E, selenium and Vitamin C were compared to actual lung cancer rates, with a clear result: the combination of antioxidants lowered lung cancer risk in male smokers. Another large study has noted that high beta carotene intake, confirmed by measures of blood levels, was associated with lower mortality rates among the elderly over a ten year period. (3) The dietary level of antioxidants is an independent predictor of plasma beta-carotene, especially in moderate alcohol drinkers. A more recent study reports, “This may explain, at least in part, the inverse relationship observed between plasma beta-carotene and risk of chronic diseases associated to high levels of oxidative stress (i.e., diabetes and CVD), as well as the failure of beta-carotene supplements alone in reducing such risk.” (4) Still, news reports continue to refer to beta-carotene as harmful, largely because of the original study reports. The “media myth” continues long after the science has moved on. Nutra-con seems to have bought into the myth. The same beta-carotene molecule is produced either synthetically or as a food extract, with the exact same optical rotation and measured by the exact same blood tests. Beta Carotene REFERENCES: 1. 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. http://content.nejm.org/cgi/content/full/330/15/1029?ijkey=bd47b716724d0dad4cad0fb19337308753658337 2. Wright ME, et al. Development of a Comprehensive Dietary Antioxidant Index and Application to Lung Cancer Risk in a Cohort of Male Smokers. July 2004 American Journal of Epidemiology http://aje.oupjournals.org/cgi/content/abstract/160/1/68?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=1&andorexacttitle=and&andorexacttitleabs=and&fulltext=beta+carotene&andorexactfulltext=and&searchid=1100534768534_1530&stored_search=&FIRSTINDEX=0&sortspec=relevance&fdate=7/1/2004&tdate=7/31/2004&journalcode=amjepid 3. Buijsse B, et al. 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). Am J Clin Nutr 2005;82:879–886. 4. Brighenti F. The total antioxidant capacity of the diet is an independent predictor of plasma beta-carotene. European Journal of Clinical Nutrition (2007) 61, 69–76. doi:10.1038/sj.ejcn.1602485; published online 12 July 2006. 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. Regarding “Biological Activity Reduced 50%”: This is certainly true for vitamin E, but your website inaccurately implies that this is true for many other vitamins. In fact, it is only true for vitamin E, but it is also true that some vitamins and minerals are absorbed better from dietary supplements than from food. This is the case for non-heme iron from plant sources, which is poorly absorbed, while chelated iron supplements are relatively well absorbed. This is also the case for folic acid, which is demonstrably less well absorbed from food than from supplementation. REFERENCES Heme iron is absorbed better than nonheme iron, but most dietary iron is nonheme iron. [8]. Absorption of heme iron ranges from 15% to 35%, and is not significantly affected by diet [15]. In contrast, 2% to 20% of nonheme iron in plant foods such as rice, maize, black beans, soybeans and wheat is absorbed [16]. Nonheme iron absorption is significantly influenced by various food components [1,3,11-15]. Dietary Supplement Fact Sheet: Iron, Office of Dietary Supplements • NIH Clinical Center • National Institutes of Health Bioavailability of food folates is 80% of that of folic acid. RM Winkels, IA Brouwer, E Siebelink, MB Katan, and P Verhoef Am J Clin Nutr 2007 85 (2): p. 465 Regarding Polarized Light and Optical Rotation: The difference is certainly true for Vitamin E, but not at all true for B-Vitamins. Your article has falsely implied that this is true for all “synthetic” vitamins. Finally: This is just a sampling of data - not a complete list of all issues of sloppy or incorrect science - to show that OTC Nutri-con's program is not accurate in:

• Implying that synthesized vitamins are all synthetic forms
• Stating that all natural source supplements are better utilized than all synthesized nature-identical materials
• Stating that synthesized material is less safe than natural material (in fact, the micro contamination from natural materials far exceeds that of synthesized ingredients)

OCA is not uniquely qualified to pass judgment on these matters after having produced such mixed-up nonsense as background material. Nutra-con seems to be a con job, in my opinion. I support OCA and do not understand why it would embark on a divisive campaign based on such highly questionable science that is so easily proven to be false or misleading. It is also questionable in promoting specific companies as providing better ingredients, even though they may not match the materials used in scientific studies that provide components that the public wants to use, in light of their proven safety and efficacy. Please allow me to ask you to reconsider your program, in the interest of truth in science. Your organization’s credibility will be challenged by the scientific community and will justifiably suffer if you proceed on this erroneous course of action in a field so far removed from your experience and expertise. This could be disastrous for OCA if all of your positions are dismissed by many people because of one seriously flawed program that could harm your reputation for integrity and scientific accuracy. It is one thing to promote naturally occurring nutrients from food sources, which is fine if the science is accurately presented. It is quite another to promote specific brands with poor scientific justification, as you seem to already be doing. This is just one man’s opinion, but I would hate to see OCA be isolated by pushing an untrue Truth campaign. I have spent a good part of my adult life defending the natural products industry, but there is no good defense for a misguided effort that misfires and winds up “shooting you in the foot”. Neil E. Levin, CCN, DANLA Certified clinical nutritionist with diplomate in advanced nutritional laboratory assessment Author of - or contributor to - many articles defending natural products:

• Say No To GMOs
• Bittter Harvest
• Benefits of herbs
• Cancer patients may very well tolerate the use of certain dietary supplements (CA: The Journal of the American Cancer Society)
• Childhood Obesity (Vitamin Retailer magazine)
• Europe Biotech
• FDA Scientists Report Political Interference in Their Work
• Green Foods (Whole Foods magazine)
• Grocery Headquarters: Biotechnology still hasn’t lived up to its promises
• LAND OF CONFUSION: HOW POOR SCIENCE AND MISLEADING MEDIA COVERAGE CREATE PUBLIC CONFUSION ABOUT HOW DIETARY SUPPLEMENTS AFFECT HEALTH (Journal of Applied Nutrition)
• Modified foods, modified truth
• More evidence of vitamin E safety!
• No appetite for biotech foods
• Organic Spices (Organic Products Retailer magazine)
• Raw Deal on Vitamins (Organic Style rebuttal)
• Reducing Healthcare Costs Naturally
• Sweeteners (Whole Foods magazine)
• The Case for Multiple Vitamins
• Who’s Afraid of GMO’s? –Me!

Neil E. Levin, CCN, DANLA Board Certified Clinical Nutritionist with Diplomate in Advanced Nutritional Laboratory Assessment www.honestnutrition.com