Regulatory Watch

Pay close attention to current and impending regulatory developments, even if they don’t specifically mention supplements.

By Douglas Kalman

Is the FDA changing the way it evaluates research in support of the efficacy (effectiveness) of weight loss products? Does your company stay abreast of changes or announcements coming from FDA or CDER (Center for Drug Evaluation and Research)?

Some companies in the natural products industry may believe there is no need to respond or offer public comment if FDA or any federal agency puts forth a “draft guidance” or “final guidance.” This is a mistake and here’s why. You can often tell what regulatory agencies are thinking in terms of what areas they have concerns with or want to move into. They often use the word “signals,” and right now I strongly believe that FDA/CDER is clearly communicating their thoughts about products for weight loss, adverse events and the need for Institutional Review Boards/Ethical Review Boards (IRB/ERB) in the research process. Thus, if your company develops or markets a weight loss product, actively engages in human clinical trials or collects “adverse events” (real or potential side effects that may or may not be related to the product), then you will be interested in the following developments.

Weight Loss Products

FDA and CDER have announced an interest in updating the 1996 “Guidance for Weight Loss Drugs.” FDA used to call pharmaceuticals for weight loss “weight control drugs,” but in February it decided to call this category “…Products for Weight Management.” The expansion in this definition should alarm those in the natural product industry—what were once “pharmaceuticals” are now “products.” This could be considered a signal from FDA that it is moving in the direction of natural products (i.e., dietary supplements) in the context of weight loss.

The FDA does note what it specifically defines as obese—a Body Mass Index (BMI) of 30 or higher. Meanwhile, the pharmaceutical giant GlaxoSmithKline (GSK) has petitioned the FDA to disallow dietary supplements marketed for weight loss to people that have a BMI of 30 or higher. This is the point at which every regulatory/legal department should be getting involved. What they should do is make a public comment to FDA about the apparent shape-shifting of who can sell products for health promotion and to what specific segment of the population the products can be targeted to.

FDA has also further defined what it considers proof of efficacy (effectiveness) for weight loss. This is important to know if you have or are planning to gather or obtain clinical support for your product. The FDA definition states that the mean absolute or percent change in body weight between the active (treatment) group and placebo group must be 5%. The second part of the definition requires that the proportion of subjects that lose more than 5% baseline body weight in the treatment group be greater than those in the placebo group. Simply stated, more people in the active group need to lose at least 5% baseline body weight than those in the placebo group. So if your treatment/active group has greater mean (average) weight loss and more people in the treatment/active group lose 5% of baseline body weight or more, then your product is deemed effective for weight loss. The FDA notes that the latter part of the definition for efficacy is strengthened if the proportion of subjects who have lost 5% baseline body weight is at least two-times that of the placebo group (this is so because more likely than not the results will be real and not be by chance, and thus it will be strongly statistically significant).

If you sponsor a study on a product and those studies meet FDA’s current definition of efficacy, then you are in a good position to defend the product if you receive a query from the FDA, FTC, BBB, NAD or NARC (all governmental or non-governmental agencies that may work together in enforcing fair trade, honest advertising and regulation of safety).

FDA’s draft guidance also details how it performs a general safety assessment of your product. It also discusses how long a study should last in order to obtain general safety data. Do all of these FDA recommendations fit the natural products industry paradigm? Not necessarily, but at least the draft guidance provides a peek into what the agency considers a minimum threshold. It is interesting to note that the FDA purposely calls for weight loss studies to include DEXA (dual-energy x-ray absorptiometry) measurements (or a suitable alternative) in order to determine weight loss from lean body mass versus from fat. Therefore, if you sell a weight loss product or are looking to retail one, you have a pretty precise guide as to what the FDA considers worthwhile to look for in terms of weight loss, safety and where weight loss occurs (fat vs. muscle).

Adverse Events, OTCs and IRBs

As is well documented by now, there is a legal framework for the over-the-counter (OTC) and natural products industry to collect consumer reported adverse events (reported side effects) and how to turn them over to the FDA. In case you missed it, companies retailing OTC medications and dietary supplements are now required to report to FDA all serious adverse events reported to the company. If you or your company is unaware of this law or how to implement it into your business, it is highly recommended that you find out all you can as soon as possible. (More information on the basics of the new AER law can be found in this month’s “Capitol Comments” column, which starts on page 28.)

The FDA also recently released a draft guidance for researchers, sponsors and IRB’s on reporting adverse events. This draft guidance is also important for the dietary supplement industry in that it is another avenue where you can collect side effect information on the use of your product under controlled conditions. This information can also provide guidance on what real or potential side effects may occur with the use of your ingredient or finished product.

Remember, an FDA draft guidance is a preview of current thinking on a particular issue, a signal as to where it is headed in enforcing laws related to the topic in the future.NW

References furnished upon request.