Once again, the dietary supplement industry is fighting efforts to give consumers more information about the safety and effectiveness of dietary supplements.
Big Supp is very clever. It sells consumers on the phony idea that they need dietary supplements for good health. Even as the evidence continues to mount that consumers don’t need supplements and shouldn’t take them, the industry continues to convince the public otherwise. And in 2011 they raked in $30 billion.
The state and federal governments have served as handmaidens to the industry in this clever marketing strategy. Congress’s gift to the supplement industry, the Orwellian-named Dietary Supplement Health and Education Act (DSHEA) “effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs, and puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective,” as SBM’s Scott Gavura pointed out. DSHEA allows supplements to make “structure and function” claims, although no one seems to know what that means, including the FDA.
States have done their part in granting chiropractors and naturopaths the authority to give “nutritional” advice and recommend dietary supplements, sometimes on the basis of dubious diagnostic testing purporting to reveal imagined nutritional deficiencies. This gives them carte blanche to sell supplements to their patients, a clear conflict of interest.
And when proposed regulation threatens their profits, the dietary supplement industry and its surrogates enlist the very public it duped to join the battle. The industry convinces the public that someone is trying to take away their access to supplements they never needed in the first place. This threat is dressed up in terms designed to push all the buttons of a public already primed to be leery of “the government” – their “health freedom” may be taken away. Actually, freedom to choose among health care practices is most threatened by withholding readily-available information which would adequately inform health care decisions.
Sen. Durbin wants more information for consumers
Sen. Dick Durbin (D-IL) has (once again) introduced legislation with some perfectly reasonable requirements designed to help consumers make informed choices about whether to use supplements. (The Dietary Supplement Labeling Act, S. 1425) Sen. Richard Blumenthal (D-CT) joins him in this effort. I’ve criticized Sen. Blumenthal for his support of a Connecticut law forcing recognition of a disease that does not exist – Chronic Lyme Disease. I don’t know if he’s seen the scientific light and now wants to protect consumers or simply doesn’t realize that the dietary supplement industry and “Lyme literate” doctors are employing variations of the same marketing strategy: selling the public on a need and then selling the public products or services to fulfill that illusory need.
In support of the bill, Sen. Durbin refers to yet another government report on the health risks of supplements. A recent Government Accounting Office report noted that between 2008 and 2011, the FDA received 2,100 reports of health problems associated with dietary supplements. However, the GAO suspects underreporting of adverse events because most consumers call poison control centers, not the FDA. (To be fair, a reported adverse event may or may not be caused by taking a dietary supplement.)
The latest report is just one of many warnings about the dangers of supplements and pleas for adequate regulation. Recently, the American College of Medical Toxicology and the American Academy of Clinical Toxicology had this to say in a joint statement:
There is a lack of stringent quality control of the ingredients present in many herbal and dietary supplements. Reliable evidence that these products are effective is often lacking, but substantial evidence exists that they may produce harm. Indirect health risks also occur when these products delay or replace more effective forms of treatment or when they compromise the efficacy of conventional medicines.
Sen. Durbin’s bill would at least partially address some of these problems. Here’s what the bill would do:
- Beef up the registration requirements for supplement manufacturers. In addition to registering, manufacturers would be required to provide the FDA with a description of each dietary supplement they make, a list of its ingredients and a copy of the label. The companies already have all of this information – at least, I certainly hope they do. This information would be available to the public.
- Require the FDA to compile a list of dietary supplement ingredients (or blends of ingredients) it determines could cause potentially serious adverse events, drug interactions, contraindications or risks to subgroups such as children and pregnant or breastfeeding women. (But not to the general public.) The Institute of Medicine would evaluate dietary supplement ingredients and provide this information, at no cost to the supplement companies.
- Require dietary supplement manufacturers to provide substantiation for their claims of health benefits, such as “structure and function” claims. Currently, manufacturers are supposed to have substantiation but need not give it to the FDA. Again, information the companies already have in their records, or should have.
- Give the FDA authority to clear up the distinction between dietary supplements and food and beverages with additives.
Big Supp doesn’t want them to have it
In sum, the bill would give consumers some of the tools necessary to do a proper risk-benefit analysis in deciding whether to take a dietary supplement. It accomplishes this with information the companies already have or which the government will provide free of charge. But the supplement industry (once again) does not want consumers to have this information. Here’s what Michael McGuffin of the American Herbal Products Association (AHPA), an industry trade group, has to say about the bill:
There are numerous authoritative references already available to provide safety information on dietary ingredients, including AHPA’s Botanical Safety Handbook for herbal ingredients . . . Instead of using taxpayer funds to reinvent the wheel, the existing resources should be recognized.
Of course, consumers would need a paid subscription to access much of this research, if it exists, including the AHPA’s Handbook, which provides information only on botanicals. As pointed out by the toxicology experts, many of these supplements have never been fully researched. And one would need a background in pharmacy or medicine to fully understand the information provided in the Handbook.
Personally (if I took supplements, which I don’t) I’d rather have the Institute of Medicine doing my research instead of a trade organization. For example, let’s compare what the AHPA says about St. John’s wort to the analysis of St. John’s wort available from Natural Medicines Comprehensive Database, which also requires a subscription. (For brevity’s sake, I’ve omitted the references.)
Pregnancy and Lactation
Studies on the effect of prenatal consumption of St. John’s wort on pregnancy in mice and rats were generally associated with normal gestation and offspring development. A limited number of human case reports indicated healthy pregnancies and infants when St. John’s wort was used prenatally.
In studies of nursing mothers, the compound hyperforin was detected in low concentrations in mother’s milk while the compound hypericin was not detected in milk.
Natural Medicines Comprehensive Database:
PREGNANCY: POSSIBLY UNSAFE …when used orally. Anecdotal evidence suggests that St. John’s wort might be safe for use during pregnancy; however, animal model research has produced contradictory findings. Other preliminary research suggests that constituents of St. John’s wort might have teratogenic effects. Until more is known, St. John’s wort should not be taken during pregnancy.
LACTATION: POSSIBLY UNSAFE …when used orally. Nursing infants of mothers who take St. John’s wort can experience colic, drowsiness, and lethargy; avoid using.
Whose advice would you follow?
According to Steve Mister, from another industry trade group the Council for Responsible Nutrition, the supplement industry does not support legislation
that directs FDA to require warning labels for products or ingredients that ‘could cause’ adverse events or potential risks as this is a case of the precautionary principle run amok. While the premise may be well intentioned, in practice this requirement would lead to confusing and unnecessary label instructions likely to deter consumers from using beneficial dietary supplements based on uncommon or miniscule risks.
But that’s not what this legislation says. It plainly states that labels would have to warn only of “potentially serious adverse events, drug interactions, or contraindications, or potential risks to subgroups” like pregnant women and children. And “beneficial”? If the industry has good evidence that using dietary supplements is beneficial why not share it with the public?
In other statements, Mister seems to want to shift the focus to supplement manufacturers and sellers who aren’t complying with DSHEA and urges more resources for the FDA to address those problems. I certainly agree with giving the agency more resources, but that doesn’t really address the issues raised by this legislation: insufficient information about health benefit claims all manufacturers are touting and knowing the health risks of taking any dietary supplement, not just those sold by companies who are out of line.
Sen. Durbin’s bill has been referred to the Senate Committee on Health, Education, Labor and Pensions. Unfortunately, according to GovTrack, it has zero chance of passing.