The U.K. steps up enforcement on DMAA. Will this inform future FDA action?
Last week, news broke that the United Kingdom–based Medicines and Healthcare products Regulatory Agency (MHRA) had instructed sports nutrition & weight loss marketers to cease selling products containing the controversial ingredient 1,3 dimethylamylamine (DMAA).
Because the ingredient has no EU medicine or novel food ingredient status or Traditional Herbal Medicinal Products Directive (THMPD) registration—and because, according to MHRA guidance, an ingredient like DMAA has a “pharmaceutical action”—the regulator bears the authority to remove the product from the market.
I corresponded with Luca Bucchini, PhD, EU food expert and managing director at Rome-based Hylobates Consulting, on this topic. “The U.K. MHRA has found in the past that products presented as supplements, including sports supplements, are, under U.K. and EU law, in fact, unauthorized medicines.”
With so many rules to enforce, it becomes a matter of which ingredients regulators choose to take action on—for the U.K., the forthcoming Summer Olympics are a definite motivation to clear out controversial products.
Novel food enforcement, Bucchini argued, has been especially weak in terms of enforcement in the U.K. As the controversy over DMAA grows, EU member states looking to nix the ingredient are likely to come at it from a medicine angle.
"I am aware of enforcement action against DMAA containing products in Italy (under food law), Spain (under medicine law), and Germany (under food law),” Bucchini said. “The general impression is that most countries will—if they do—deal with DMAA under medicine law, with few exceptions.” Other ingredients under scrutiny include ephedrine, yohimbine and DHEA.
“There is little doubt about products with DMAA being illegal in the EU,” Bucchini said. “The issue is about enforcement priorities.
“As for the FDA, I can speculate that the MHRA is in touch with them about DMAA. However, the regulatory environments are very different. Some EU regulators are hoping that the FDA steps would solve the problem for them. Still early, I believe. In the end, I am afraid that the occurrence—or lack of occurrence—of further serious adverse events will determine the future of DMAA.”
Nutrition Business Journal argues here—in the cover story of our February 2012 Sports Nutrition & Weight Loss issue—that DMAA could become an important U.S. regulatory touchstone sometime soon.
What do you think should be done about DMAA in the U.S.? Share in the comments.