Dietary Supplements: HHS’ Office of Inspector General Raises Concerns on Mislabeling
By Mike Rozembajgier
Whether its products for weight loss or immune system support, dietary supplements in the U.S. are used by 80 percent of adults.
With this number on the rise, several public interest groups, stakeholders and even the Government Accountability Office (GAO) have raised concerns in recent years over the lack of federal oversight of this $20 billion-a-year industry.
Most recently, the Department of Health and Human Services’ (HHS) Office of Inspector General took issue with structure/function claims made by dietary supplement makers.
Currently, makers of dietary supplements are held liable for ensuring the accuracy and truthfulness of such claims. But they are not pre-approved by the U.S. Food and Drug Administration (FDA), leaving many concerned about consumers being potentially misled by claims that lack scientific backing.
So what exactly constitutes a structure/function claim?
According to a recent HHS report, structure/function claims are statements that:
- Describe the role of a dietary supplement in the structure and function of human bodies; or
- Claim a benefit related to a classical nutrient deficiency disease and disclose the prevalence of such a disease in the U.S.; or
- Characterize the document mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or
- Describe general well-being from consumption of a nutrient or dietary ingredient.
In its recent analysis of structure/function claims of 127 dietary supplements marketed for weight loss or immune system support, the HHS’ Office of Inspector General found that 20 percent included labeling that made illegal claims to cure or treat a disease. Also substantiation documents submitted for the sampled supplements were, overall, inconsistent with FDA guidance on competent and reliable scientific evidence.
These results led the HHS’ Office of Inspector General to identify three recommendations for FDA’s consideration:
- Seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading;
- Improve upon the notification system for these claims to make it more organized, complete and accurate; and
- Expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims.
In its comments on the report, FDA agreed with the second and third recommendations but disagreed on the first recommendation.
Are you surprised by the HHS’ Office of Inspector General’s report findings? Do you believe the dietary supplement industry needs to be further regulated by FDA? We welcome your thoughts below.
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