The NAAG’s recent 2015 Fall Consumer Protection Seminar included an hour long discussion of herbal supplements, with the panel including Dr Pieter Cohen from Harvard Medical School, Maia Kats, director of litigation for Center for Science in the Public Interest, and Rend Al-Mondhiry, regulatory counsel at the Council for Responsible Nutrition (CRN).
Spiked products
CRN’s Rend Al-Mondhiry asked the assistant state Attorneys General to help the industry and its consumers by prosecuting companies that spike products with illegal drugs and market them as dietary supplements.
“These types of activities clearly violate the law and present real risks to public health,” she said. “This is where state AGs can be most effective in protecting consumers and can coordinate with FDA to target these illegal products.”
During the panel, Al-Mondhiry explained the important role of FDA and federal regulation, including extensive good manufacturing practices (GMPs) that mandate 100% identity testing for raw materials and specifications for purity and strength, among other requirements. The federal legal framework for dietary supplements also provides FDA with various enforcement tools to take action against illegal ingredients and illegal claims, from seizures and mandatory recalls to civil and criminal penalties.
“Another key piece contributing to consumer safety is mandatory post-market surveillance—a law the dietary supplement industry helped to pass,” she said. [The 2006 Dietary Supplement and Non-Prescription Drug Consumer Protection Act requires reporting of all serious adverse events to the FDA and recordkeeping of all adverse event reports a company receives about its products.]
Al-Mondhiry advised that, despite various self-policing efforts, the industry doesn’t have an enforcement hammer to bring down on companies that actively ignore the laws. FDA, working with state agencies, including state AGs, can target the intentional wrongdoers who introduce illegal products and pass them off as dietary supplements, she said.
“CRN wants to continue working with FDA and also with the state AGs to help address this issue,” said Al-Mondhiry.
Do botanicals represent the majority of the spiked product problem?
Also in attendance were representatives from the FDA and the FTC, said Loren Israelsen, President of the United Natural Products Alliance (UNPA), who attended as an observer.
Loren Israelsen, President of the United Natural Products Alliance (UNPA), who attended as an observer, told us there were a lot of shared talking points between Dr Cohen, Kats and the seven articles published this week in Drug Testing and Analysis.
“It was clear that spiked products, wherever they show up, are the number one target class of products. Within that, the panelists believe that botanicals represent the majority of the problem, so, in their minds, this is the part of the law that needs to be reformed.
“Look at the paper by Marcus in Drug Testing and Analysis; he states that botanicals do not supplement the diet, and they may cause severe adverse effects.”
Israelsen noted that that there were about 200 people in the room (including approximately 80 assistant state Attorneys General) and that the session was “beautifully orchestrated”. “The aim was to teach the assistant AGs the fundamentals, and both Cohen and Kats from CSPI were very emotionally engaged, saying that supplements are a real problem.”
“We’re all against spiking – in weight loss products or sports nutrition products or wherever – but it is clear that the execution required to remove these products from the market is challenging. The paper by Sharfstein offers a simple proposition, which is very attractive as a principle, but any serious consideration of it requires a great deal of discussion and deliberation by all of the stakeholders involved.”
Key papers
The meeting followed hot on the heels of the November 2 issue of Drug Testing and Analysis, which included seven articles related to dietary supplement issues. Links to the articles, all of which are open access, can be found below
Breaking the gridlock: Regulation of dietary supplements in the United States
Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ — Hawaii, 2013
Self-reported side-effects associated with use of dietary supplements in an armed forces population
History full circle: ‘Novel’ sympathomimetics in supplements
Dietary supplements: What's in a name? What's in the bottle?