The Institute of Medicine (IOM) is calling on Congress to give the U.S. Food and Drug Administration (FDA) increased authority for regulating health claims on food and dietary supplements. Specifically, the IOM wants FDA to hold food and supplement health claims to the same standards as it uses for drugs.
Right now, the scientific evidence for enabling drugs, foods and supplements to carry a health claim varies. According to the IOM, FDA reviews the safety and efficacy of an entire drug product, but for foods, only evaluates the safety of individual ingredients. “FDA has been hampered in its ability to assess the proliferation of health claims being made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid and appropriate measurements to substitute for clinical outcomes,” the IOM commented.
The IOM said in a recent report (viewable at http://national-academies.org/morenews/20100512.html) that there is no good scientific reason for using different standards since they share the goal of improving one’s health. The IOM suggested a new system for judging the appropriateness of studies that back up health claims for drugs, medical devices, biologics food and supplements “consistently and fairly.” The framework includes using reliable biomarkers, validating that the biomarkers can be used accurately and confirming there is strong enough evidence to use such markers.
Of interest to this industry, the IOM wants Congress to give FDA the ability to study how consumers understand claims on foods and supplements. And, it wants to encourage the collection and sharing of data about biomarkers for drugs, biologics, medical devices, foods and supplements.
Regulatory expert Vincent Annunziata of Nutritional Supplement Compliance Solutions, LLC feels that this is inappropriate. “The current process gives the FDA significant authority. Harmonizing the standards will not offer any additional benefits. Could the IOM be addressing the issue of structure function claims?”
He adds that Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)) already requires supplement makers to have substantiation that a claim is truthful and not misleading. If food or supplement makers claim a product has drug-like benefits, FDA can take enforcement action, he says.
Regarding endpoints, FDA uses two endpoints with which to identify disease risk reduction when evaluating health claims, Annuziata explains: disease incidence reduction and beneficial changes in surrogate endpoints (biomarkers) for the disease. Surrogate endpoints are only used in certain cases (such as for colon cancer, coronary heart disease/stroke, osteoporosis, diabetes and dementia). “Why would a food or supplement manufacturer go through the complex petition procedure to secure a health claim for macular degeneration if the National Institutes of Health (NIH) and ultimately FDA, do not recognize surrogate endpoints? In fact, the FDA would probably agree that they are receiving very little if any health claim petitions these days,” Annunziata states.
The Natural Products Association issued a comment in response to the report saying that the review of FDA’s regulatory authority for food claims is outside IOM’s area of expertise.
Published in WholeFoods Magazine, July 2010 (published ahead of print on May 27, 2010)