FDA faces barrage of criticism over plans to assess safety of supplementsBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e583 (Published 25 January 2012) Cite this as: BMJ 2012;344:e583
A plan by the US Food and Drug Administration to assess the safety of nutritional supplements is facing criticism for being not enough to protect the public from harm.
The latest complaint arises in an article in the New England Journal of Medicine (doi:10.1056/NEJMp1113325) in which Pieter Cohen, an assistant professor at Harvard Medical Schools, warns, “If the FDA succumbs to industry pressure, the public health consequences will be significant.”
While applauding the agency for acting “before a public health crisis forces it to do so,” Professor Cohen cautions against the FDA’s intended reliance on documented history of an ingredient’s use instead of experimental data. By insisting on scientific evidence to demonstrate the expectation of safety, the FDA would not only improve the safety of new supplements but also create a database of evidence to guide regulators and consumers, he writes.
A report from the Institute of Medicine in 2004 noted that “even widespread historical use without documented ill effects is no guarantor of long-term safety” (http://www.nap.edu/catalog.php?record_id=10882).
Food additives can face tougher regulatory hurdles than supplements. “A chemical preservative sprayed inside a can of tomato soup or the purple die in Jell-O requires much more evidence of safety than ingredients used in supplements,” writes Professor Cohen.
US citizens spend more than $28bn (£18bn; €21bn) a year on multivitamins, herbal tablets, pills to improve sexual performance, and other such supplements, which are currently regulated more like foods than pharmaceuticals. They are deemed safe unless shown otherwise, with no requirements for clinical trials or marketing approval.
After much delay the FDA proposed its guidance on new dietary ingredient notifications six months ago. Comments on the plans have swollen to more than 146 000 pages, with the supplements industry, consumer groups, and researchers all complaining about the plan’s scope and procedures for assessing the safety of ingredients.
The industry has successfully prodded the agency into extending a period for public comment to a year. Judy Blatman, a senior vice president of the Council for Responsible Nutrition, told the BMJ, “The proposed guidelines are unreasonably burdensome without providing true extra protection for consumers.”
Many manufacturers are concerned about the costs of compliance. One industry estimate is that companies could spend between $450 000 and $6.6m for each ingredient in a product. Scott Polisky, a lawyer for the Los Angeles based company Jarrow Formulas, warned in a letter to the FDA that such costs would result in “a chilling effect on dietary supplement innovation with an attendant effect on the public health.”
The FDA plan is about 17 years behind schedule. The 1994 Dietary Supplement Health and Education Act created the regulatory framework, but the agency failed to iron out details and enforce a requirement that manufacturers provide evidence supporting a “reasonable expectation of safety.” Under the act, dietary supplements with ingredients sold in the United States before 1994 can be legally marketed without any evidence of safety or efficacy. As a result, many of the estimated 51 000 dietary supplements sold in the US contain ingredients that have never been assessed for safety.
The chief authors of the 1994 act, the senators Orrin Hatch and Tom Harkin, urged the FDA’s commissioner, Margaret Hamburg, on 22 December to withdraw the blueprint because it would “undermine” the law they championed. Many supplement companies operate in Mr Hatch’s home state of Utah, and he has long aided the industry in Congress and by intervening with regulators. His son and some former aides have been lobbyists for the industry, which spent $2.1m on lobbying in Washington, DC, in 2011, says the non-partisan Center for Responsive Politics.
Some limited policing of dietary supplements exists. The FDA investigates consumer reports of serious illnesses, of which there have been thousands over the past three years, including dozens of fatalities. Further investigation sometimes underscores the broader concern among health authorities about unexamined ingredients.
Professor Cohen cites a sexual enhancement supplement recalled by the FDA on 11 August last year as an example of the potential peril of supplements. Zotrex was sold to nearly 14 million customers under trade names such as Stiff Nights, Size Matters, and OMG. It contains sulfoaildenafil, a drug similar to the FDA approved sildenafil (marketed as Viagra). But sulfoaildenafil has never been tested on humans, and it may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels, said the FDA.
The supplements industry argues that its products have a wider margin of safety than pharmaceutical drugs, with none of the same immediate and dramatic effects on the body.
Cite this as: BMJ 2012;344:e583
The draft FDA guidance is at http://1.usa.gov/w6SJ8c.