By Megan Fanale Engel
The OIG’s report entitled Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements analyzed structure/function claims that manufacturers may use on dietary supplement labels to promote their products.
A structure/function claim describes how an ingredient in the dietary supplement will affect or maintain a structure or function in the human body.
Manufacturers must ensure that the structure/function claims they make are truthful and accurate, but the FDA does not preapprove such claims.
Although the FDA does not require manufacturers to submit documentation substantiating the claims to the agency, some manufacturers voluntarily disclose this information. However, manufacturers are required to notify the FDA when they use a structure/function claim on the product’s label and include the text of the structure/function claim.
In addition, manufacturers must include a disclaimer on the product’s label stating that the claim has not been reviewed by the FDA, and “the product is not intended to diagnose, treat, cure, or prevent any disease.”
The OIG’s study reviewed 378 structure/function claims on the labels of 127 dietary supplements to determine whether the claims complied with current FDA regulations.
The OIG found that 66 of the 104 manufacturers voluntarily submitted documentation substantiating the claims on their products’ labels.
According to FDA guidance, most of the information consisted of background information. In addition, of the 34 percent of documentation that involved human studies, none met the FDA’s guidance regarding reliable scientific evidence.
The OIG also found that seven percent of the supplements in the sample (nine supplements) did not have the required disclaimer regarding structure/function claims on their labels. Last, 20 percent (26 supplements) in the sample had claims on the labels stating that the supplements could treat diseases, which is prohibited by the FDA.
The OIG provided three recommendations to the FDA:
- that the FDA seek explicit authority from Congress to require dietary supplement manufacturers to submit documentation substantiating their structure/function claims.
- that the FDA improve the system through which manufacturers notify the agency regarding structure/function claims.
- that the FDA increase its surveillance activities over the dietary supplement marketplace to ensure that disclaimers are included on all dietary supplement labels and to discover any prohibited disease claims.
The blog was prepared by Megan Fanale Engel, an attorney in Fulbright's health care practice.