HHS Lambasts Dietary Supplement Companies and Weight Loss & Immune Support Dietary Supplements

The Department of Health and Human Services Office of Inspector General issued two reports lambasting dietary supplement companies, particularly over structure-function claims related to weight loss and immune support.

The government report on dietary supplements for weight loss and immune support stated:

We analyzed structure/function claims for a purposive sample of 127 dietary supplements marketed for weight loss or immune system support. We reviewed the claims to determine the extent to which they complied with FDA regulations. We reviewed substantiation provided by manufacturers to describe the quantity and nature of the evidence. We also assessed the accuracy and completeness of notification letters that manufacturers must submit to FDA for their structure/function claims.

Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.

We recommend that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading. We recommend that FDA improve the notification system for these claims to make it more organized, complete, and accurate. We also recommend that FDA expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In its comments on the draft report, FDA did not explicitly concur with our first recommendation, but said it would consider it. FDA concurred with our second and third recommendations.

The second report was critical of failure by many dietary supplement companies to register as establishments with the FDA:

Twenty-eight percent of contacted companies had facilities that failed to register with FDA as required. Of the companies with facilities that did register, 72 percent failed to provide the complete and accurate information required in the registry. Finally, 20 percent of dietary supplement labels in our sample did not provide the required telephone numbers or addresses.

We recommend that FDA: (1) improve the accuracy of information in the registry, (2) seek authority to impose civil monetary penalties on companies that do not comply with registration requirements, and (3) educate the dietary supplement industry about registration and labeling requirements. FDA concurred with all of our recommendation

The FDA and FTC have long been concerned with dietary supplement claims concerning weight loss, in particular.

See, for example:

• FDA raises legal issues re use of HCG for weight loss

• Dietary supplement claims & labeling

More recently, the FDA has been conducting a study of consumer perceptions of qualified health claims. No doubt the DSHEA was a huge consumer victory against FDA control of access to dietary supplements. The FDA now has many tools at its disposal to determine whether substantiation requirements and limitations on structure-function claims are truly being followed.

*

The Cohen Healthcare Law Group represents dietary supplement manufacturers, distributors, and inventors who need legal advice to aggressively market their dietary supplements without running afoul of relevant laws and regulations. Contact our dietary supplement and FDA attorneys for a legal consult.