FDA recently announced a recall that could have a significant indirect effect on the manufacturers of many dietary supplements currently on the market. On May 1st, 2009, the agency recalled 14 Hydroxycut brand products based on adverse event reports of serious liver injuries. Iovate Health Sciences, Inc., the manufacturer of the Hydroxycut brand of products, has agreed to recall all Hydroxycut products with the exception of Hydroxycut Cleanse and Hydroxycut Hoodia. In its recall announcement, FDA took the additional step of warning consumers to discontinue use of Hydroxycut products immediately.

In view of this recent recall, companies in the dietary supplement industry need to reevaluate and strengthen their policies on safety. FDA’s announcement indirectly affects the manufacturers of dietary supplements containing the same or similar ingredients as those used in Hydroxycut products, but it will also likely raise questions at the agency, in Congress and among consumers about the safety of dietary supplements in general, and weight loss supplements in particular. Recent events underscore the fact that investments in monitoring of safety are necessary for any successful dietary supplement manufacturer, and may be even more important in the days to come.

Need for Increased Safety Testing and Monitoring

Under the Dietary Supplement Health and Education Act (DSHEA), dietary supplement manufacturers shoulder the responsibility for substantiating the safety of their products. However, while the cGMPs require manufacturers to confirm that their products are unadulterated and properly labeled, they do not address the safety of the ingredients themselves, the safety of ingredients in combination with other ingredients, or the safety of the ingredients in combination with widely used medications. In fact, substantiating these elements of safety is a responsibility that goes beyond compliance with cGMPs.
The general public, Congress and FDA may see the most recent recall as an indication that there has been too little emphasis on safety testing in recent years. The need to demonstrate a serious concern for safety, and the ability to ensure safety, is even more important given the fact that FDA is poised to make a critical decision regarding the regulatory status of weight loss supplements. On April 17th, 2008, in an effort to protect its market share for the FDA-approved weight loss drug alli, GlaxoSmithKline (GSK) submitted a Citizen Petition asking FDA to reclassify all weight loss support claims for dietary supplements as disease claims. FDA has yet to act on this petition, but should the agency determine that weight loss support claims are indeed disease claims, then weight loss supplements as we know them would disappear from the market altogether. Moreover, while nothing has been introduced in the current session of Congress to date, this body’s very negative current view of FDA may lead to some legislation addressing the safety of dietary supplements, if the industry is seen as unable to police itself in that regard.

Considerations for Industry

First and foremost, dietary supplement manufacturers should continually update and reevaluate the evidence of safety behind their ingredients and formulations. In the coming months, it will be particularly important to reevaluate safety data on ingredients and formulas that have any relation to those used in the recently recalled Hydroxycut products. In fact, dietary supplement manufacturers should be continually monitoring new and emerging data on their ingredients, and combination of ingredients, regardless of actual enforcement actions taken by FDA. Manufacturers are well advised to have a system in place whereby they regularly review all safety reports issued by FDA and industry groups, which might be related to their ingredients or formulations. Going a step further, manufacturers should also use the Freedom of Information Act to seek adverse event reports and MedWatch reports related to their ingredients, even if the adverse events reported were connected to a totally different dietary supplement.

Overall, manufacturers of dietary supplements should be proactive, rather than defensive, when it comes to safety. This is particularly true for manufacturers of weight loss supplements given the recent negative attention focused on such products. If a dietary supplement manufacturer does not already have a system in place designed to accept, analyze and facilitate action on consumers’ health-related complaints, it should move quickly to establish such a system.

In response to reports of adverse health events, whether pursuant to a notice from FDA or an individual customer, a dietary supplement manufacturer should engage a toxicologist in order to understand the scientific basis for the report, or lack thereof. Often, an adverse event report is unrelated to consumption of the dietary supplement at issue. However, a toxicologist will be in a better position to determine whether the adverse event in question is related to a particular dietary supplement. In cases where the dietary supplement is “very unlikely” to have been related to the adverse event, it will always be useful to have a toxicologist’s report confirming that fact. However, if the toxicologist determines that the dietary supplement might be related to the reported adverse event, he or she might also be helpful in assessing the percentage likelihood that consumption of the dietary supplement actually “caused” the adverse event, as well as assessing the likelihood of reoccurrence.

Manufacturers should consider developing long- and short-term safety testing for all of their marketed products, in addition to relying on studies demonstrating the safety of their ingredients. In some cases, it may be useful to identify regular users of certain products and monitoring their experiences with the products through online surveys, telephone surveys or other means. As the success and usage of a product increases, the risk of negative side effects associated with that product also grows exponentially. Therefore, manufacturers should view increased success on the market as going hand-in-hand with an increased obligation to test for safety, monitor safety reports, and take decisive action based on adverse event reports.