This isn’t from me, folks, but someone who is FAR more qualified: Dr. Corey Hilmas. Enjoy. Have a great Fourth of July weekend.
In the aftermath of the Consumer Protection Subcommittee hearing, “Protecting Consumers from False and Deceptive Advertising of Weight –Loss Products,” weight loss claims were thrust into the national spotlight. The Senate hearing was designed to solicit feedback on how to better handle weight-loss products marketed and advertised as quick-fix cures for a significant and widespread health problem in the United States. Consumers often look for the magic bullet to weight loss; but, ultimately, they want the marketing and advertising to be truthful and not misleading so they can make informed decisions among the available choices.
While the ideal diet pill may not exist, there are dietary ingredients with excellent data behind them. The challenge to manufacturers and suppliers of dietary ingredients is to sift through the mounds of scientific data available on ingredients and determine which ones have sufficient substantiation to support weight-loss claims. Even though the regulatory environment may seem to tip the scales toward the importance of ingredient safety, research on ingredient efficacy for substantiation is paramount to navigating the minefield of claims used on weight-loss products.
While many manufacturers want to extol the virtues of an ingredient’s benefits on weight reduction, we need to know the regulatory rules of the road regarding these claims. Federal programmatic initiatives are underway to crack down on unsubstantiated claims as well as disease claims made by weight-loss marketers. It is not always easy to draw a clear line between a structure/function and a disease claim, but weight-loss claims have a clear line of demarcation.
Claims for weight loss are permitted under the Federal Food Drug and Cosmetic Act (FFDCA), but claims related to obesity are not permissible. While the U.S. Food and Drug Administration (FDA) “weighs” in on claims that cross the line beyond allowable structure/function claims to disease claims, the Federal Trade Commission (FTC) focuses resources on claim substantiation.
The FTC is generally not concerned with whether the claim is a structure/function or disease claim because it looks at whether the marketer has a reasonable basis for the claim. An unsubstantiated disease claim may “weigh more heavily” into the FTC’s analysis of what cases to bring in, such as those affecting consumers’ health or safety (e.g., delayed treatment for a disease versus an unsubstantiated structure/function claim). In the case of claims made for dietary supplements or ingredients, they must be supported by “competent and reliable scientific evidence” to include tests, studies, or other scientific evidence evaluated by people qualified to review it. To meet this standard, manufacturers and suppliers of ingredients and supplements should give careful consideration to the following when substantiating structure/function claims:
- Totality of the evidence. If evidence is contradictory or shows inconsistencies among the available study data, substantiation will be questioned.
- Quality of the evidence. The paradigm shift of the early ‘90s in evidence-based medicine (EBM) made human randomized, double-blind, parallel group, placebo-controlled trials the “gold standard.” It makes us wonder what previously guided decision making in medicine before the era of EBM. Other human or nonhuman studies may be used to substantiate a weight-loss claim, but greater scrutiny will be placed upon factors in the studies’ methods. The FTC’s latest push to require two double-blind randomized control trials to support claims is not borne out of any current legal or regulatory authority.
- Meaning of the claim being made. If the study endpoints support an increase of metabolism but not actual weight loss, the substantiation does not support the meaning of a claim to promote weight loss.
- Relationship of the evidence to the claim. Does the evidence test the product itself or an amount/potency of the active ingredients similar to the product? Does the evidence support a direct effect on a structure or function of the body in a healthy population?
The Natural Products Foundation, in addition to facilitating research and education related to natural products for the benefit of consumers and industry, started a program to help manufacturers, suppliers, and others with substantiation and promote truth in advertising. For more information about the Truth in Advertising campaign, visit www.naturalproductsfoundation.org.
Corey Hilmas, M.D., Ph.D., oversees the development and implementation of all educational, scientific and compliance programs (cGMP, Natural Seal, TruLabel, and others) at the Natural Products Association (NPA) and provides guidance on clinical issues, public health, ingredients and regulatory compliance. Dr. Hilmas, a medical doctor with a degree from the University of Maryland School of Medicine and a doctorate in pharmacology and toxicology, joined NPA after having served as Chief of the Dietary Supplement Regulation Implementation Branch within the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA) for more than two years. In addition to managing enforcement related to cGMPs, labeling, claims, dietary ingredient safety, and imports/exports, he was a federal expert witness on label claims and dietary ingredient safety and received multiple FDA awards for enforcement initiatives. Dr. Hilmas also served as Senior Toxicologist for dietary ingredients at the FDA. Prior to his service at the agency, Dr. Hilmas was the Responsible Official for Biological Select Agent Toxins and principal investigator for the U.S. Army. Dr. Hilmas gained an interest in dietary supplements while investigating the efficacy of two dietary ingredients galantamine and huperzine-A. He earned his Bachelor’s degree from the University of Colorado at Boulder in biochemistry and molecular biology.