The Council for Responsible Nutrition (CRN), the dietary supplement industry’s leading trade association, today issued concern on behalf of responsible companies with government findings that an unacceptable number of companies are not following the law. The two reports were issued today by the Office of the Inspector General (IOG) at the Department of Health and Human Services (HHS).
According to CRN President & CEO Steve Mister, “We are disappointed that despite the fact that the large majority of dietary supplement companies in this industry are holding up their end of the bargain with consumers, there are still some companies that are not meeting their obligations under the law. Further, we are concerned by FDA’s apparent lack of enforcement against problems that are easily visible and clearly illegal. Both the industry and FDA should do better on behalf of the more than 150 million Americans who take dietary supplements.”
The first report, “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” dealt specifically with label claims, finding that approximately two dozen companies (selling weight loss and immune function products) were illegally labeling products, making claims that are prohibited for dietary supplement labels. Consumers need to be aware that dietary supplements cannot be sold with labels that specifically promise to treat, cure, prevent or mitigate a disease. Mr. Mister said, “We hope that FDA will take immediate action against these companies whose mislabeling makes those products adulterated under the law.”
In response to another finding in the report, Mr. Mister stated, “We are also dismayed at the lack of supporting science provided by some of the companies whose products were reviewed—one even using a handwritten college term paper to support its structure/function claims. Companies selling legitimate products need to have in their possession reputable scientific literature to support claims, and we believe our member companies do. Handwritten papers, your own advertisements, or your mother’s blessing just don’t cut it. What is acceptable for structure/function claims under the government’s regulations is a variety of credible evidence including results from animal, observational, and randomized clinical trials.” CRN added that the requisite evidence is dependent upon the nature of the claim.
CRN pointed out that the IOG report is not a representative sample of the industry’s products.
The second report, “Dietary Supplements: Companies May be Difficult to Locate in an Emergency,” pointed out that some companies are still not including their phone number or address on the product label; and the report was critical of FDA’s inability to collect, manage and access the registration information it already receives. Our advice to consumers—read the label, and if there is neither a phone number nor an address on the product label, don’t purchase the product.”
CRN views this report as a reminder to consumers to be savvy about the dietary supplements they purchase. “CRN has a tip sheet on its website to help ensure consumers are able to identify and purchase legitimate products from legitimate companies. The government reports are not a cautionary tale about the entire industry, but rather a cautionary tale for consumers to choose wisely.”