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

More evidence of vitamin E safety!

More evidence of vitamin E safety! According to a new study published in the American Journal of Clinical Nutrition1, male smokers in a study population who had the highest blood levels of vitamin E suffered significantly fewer deaths than comparable male smokers who had lower blood levels of this essential vitamin. Researchers from the National Cancer Institute at the National Institutes of Health teamed up with their counterparts in Finland to review the relationship of blood levels of vitamin E (alpha tocopherol) and all-cause mortality in male smokers age 50-69 in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study. The study included 29,092 men, with follow-ups continuing over a period of up to 19 years. For those in the groups with the highest blood levels of alpha-tocopherol, there was an 18% lower risk of deaths from all causes. Included in this figure are results relating to specific causes of death, including a 21% reduction in deaths from cancer, a 19% reduction in deaths from cardiovascular disease and a whopping 30% reduction in deaths from all other causes. The report reached this conclusion: “Higher circulating concentrations of alpha-tocopherol within the normal range are associated with significantly lower total and cause-specific mortality in older male smokers.” A non-reproduced meta-analysis6 warning of the largely theoretical dangers of taking vitamin E supplements has generated a lot of concern and a large decline in vitamin E usage, though this flies in the face of other, more rigorous studies showing that higher levels of serum vitamin E are associated with lower mortality numbers.1, 3-4, 7 These largely unsubstantiated warnings may be doing a disservice to figures showing that “93% of men and 96% of women in the United States do not consume the recommended daily amount of dietary vitamin E”.2, 5 In another study, ALS (amyotrophic lateral sclerosis) mortality was 62% lower among long-term users of vitamin E than among nonusers.8 Also, in a study of cancer patients done for the US Dept. of Health and Human Services, “Subgroup analysis did identify a statistically significant 9% reduction in all cause mortality” and “13% reduction in all-cancer mortality associated with supplemental vitamin E in combination with other micro-nutrients.”9 REFERENCES: Margaret E Wright, Karla A Lawson, Stephanie J Weinstein, Pirjo Pietinen, Philip R Taylor, Jarmo Virtamo and Demetrius Albanes. Higher baseline serum concentrations of vitamin E are associated with lower total and cause-specific mortality in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. American Journal of Clinical Nutrition, Vol. 84, No. 5, 1200-1207, November 2006. (Researchers were from the Nutritional Epidemiology and the Genetic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, and the Cancer Prevention Fellowship Program, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, and the Department of Health Promotion and Chronic Disease Prevention, National Public Health Institute, Helsinki, Finland) Maras JE, Bermudez OI, Qiao N, Bakun PJ, Boody-Alter EL, Tucker KL. Intake of alpha-tocopherol is limited among US adults. J Am Diet Assoc2004; 104 :567 –75. Traber MG. How much vitamin E? ... Just enough! Am J Clin Nutr. 2006 Nov;84(5):959-960. PMID: 17093143 Wright ME, Lawson KA, Weinstein SJ, et al. Higher baseline serum concentrations of vitamin E are associated with lower total and cause-specific mortality in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Am J Clin Nutr2006; 84 :1200–7. Food and Nutrition Board, Institute of Medicine. Dietary reference intakes for vitamin C, vitamin E, selenium, and carotenoids. Washington, DC: National Academy Press, 2000. Edgar R. Miller, III, MD, PhD; et al. High-dose vitamin E supplementation may increase all-cause mortality, a dose response meta-analysis of randomized trials. Annals of Internal Medicine: Online: Nov. 10, 2004: Print: 4 January 2005 Volume 142 Issue 1 John N Hathcock, et al. REVIEW ARTICLE: Vitamins E and C are safe across a broad range of intakes. American Journal of Clinical Nutrition, Vol. 81, No. 4, 736-745, April 2005. Vitamin E intake and risk of amyotrophic lateral sclerosis. Ann Neurol. 2005 Jan;57(1):104-10. PMID: 15529299 Shekelle P, et al. Effect of the supplemental use of antioxidants vitamin C, vitamin E, and coenzyme Q10 for the prevention and treatment of cancer. Evid Rep Technol Assess (Summ). 2003 Oct;(75):1-3. Review. PMID: 15523748

Cleveland Clinic makes untrue statement regarding natural vs synthetic vitamins

On August 17, 2006 I submitted this request to the Cleveland Clinic for a correction to its web site, specifically regarding their claim that "There is no difference between natural vitamins and synthetic vitamins". My reference relates to a known difference between natural and synthetic vitamin E (to date, no correction has been made): On your web page (http://www.clevelandclinic.org/health/health-info/docs/0900/0955.asp?index=5429 regarding Diet, Exercise, Stress, and the Immune System) you make a false statement that "There is no difference between natural vitamins and synthetic vitamins." On the NIH Office of Dietary Supplements website (http://ods.od.nih.gov/factsheets/vitamine.asp) they clearly state that "The synthetic form is only half as active as the natural form [4]. [4} U.S. Department of Agriculture, Agricultural Research Service. 2004. USDA National Nutrient Database for Standard Reference, Release 16-1. Nutrient Data Laboratory Home Page, http://www.nal.usda.gov/fnic/foodcomp Please correct this error.