BY MICHAEL JOHNSEN
As much as there is the stigma that dietary supplements are unregulated or underregulated, nothing could be further from the truth, noted Andrew Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition. “It continues to baffle me why the industry is still referred to as an unregulated industry,” he said last month, during the Drug Store News Pharmacy Development Series on vitamins, minerals and dietary supplements. “There [are pre-market] notification, labeling requirements, mandatory adverse-event reporting, supplement-specific [good manufacturing practices], facilities must be registered, and the [Food and Drug Administration] and the [Federal Trade Commission] review healthcare claims and advertisements,” he said.
Perhaps the most illustrative example of the FDA’s active policing of the dietary supplement industry was the removal of the thermogenic ephedra from the market in 2004. “This is one of several incidences that moved the [adverse-event] legislation forward,” he noted. In 2004, the FDA had queried Metabolife, the lead marketer of ephedra products at the time, on whether it had any adverse-event reports, Shao said. And while there was some debate between Metabolife and the FDA on the actual definition of adverse events, it turned out that Metabolife had thousands upon thousands of reports that it initially withheld from the FDA, he added.
Specifically with the GMPs, which go live for the largest of manufacturers this summer, supplements will be regulated for the identity of ingredients, the purity of product, the strength of formulation and the composition of the supplement. The dietary supplement GMPs are an amalgamation of both food GMPs and nonprescription drug GMPs, as food GMPs, for example, have historically concentrated on the cleanliness and sanitation in the production of food products.
“The supplement GMPs are sort of a hybrid of all these different regulations that came before,” Shao explained. “They are based basically
on food [GMPs], but there are aspects of drug GMPs that are in supplement GMPs. … Part of the reason why supplements are a blend of all these [regulations] is because of all the time that passed between 1994 [when the Dietary Supplement
post-GMPs, necessarily, he said. But, arguably, those higher standards ought to make it more difficult to criticize the industry as unregulated, as well as materially improve the quality of products reaching the shelf, which should correlate to
ing to improve its image by submitting advertising challenges to the National Advertising Division through a program supplemented by CRN. Self-regulation also can help influence public perception of the industry, Shao noted, because it
Andrew Shao of the Council for Responsible Nutrition said new dietary supplement GMPs will make it more difficult for the industry to be criticized as “unregulated.”
Health and Education Act was enacted] and the time [GMPs] were issued last year.”
The only shortcoming of dietary supplement GMPs, thus far, is that the GMPs only extend to the dietary supplement manufacturers—the raw ingredient suppliers are still beholden to food GMPs. “The onus is really on the manufacturer to ensure the quality of product,” Shao said, which could prove problematic for a specific manufacturer if it isn’t diligent in screening its raw ingredient manufacturers. “[This is] perhaps the most critical component of the GMPs,” Shao stressed. “Garbage in, garbage out. If you source the right raw materials, then the chances are the product at the end is going to be the right quality product.”
However, the dietary supplement GMPs are expected to improve the reputation of the industry, he noted, with the implementation of higher standards and a better range of accountability, which in turn is expected to increase consumer confidence in the category.
It’s not that consumers will notice the difference between pre- and
fewer negative stories and more efficacious products resulting from the better quality control of ingredients.
Another expected boost to dietary supplement confidence is the Adverse Event Recording Act that was passed in December, which requires dietary supplement manufacturers, along with manufacturers of monographed OTC medicines, to turn any serious adverse-event reports over to the FDA. “This is really the right thing to do for consumers,” Shao said. The value in an established adverse event recording system is that it enables the FDA to detect trends in the use of products as a sort of post-marketing tool.
The expected added value for the dietary supplement industry, he explained, ought to be the lack of those serious adverse events associated with supplements. “Dietary supplements are very safe and associated with relatively few serious adverse-event reports … so there is nothing to hide,” he said. “It reinforces the safety of [dietary supplement] products—or it will, ultimately, once the system is fully implemented.”
Finally, the industry is also look-
brings more scrutiny of dietary supplement claims in an appropriate third-party forum.
Self-regulation is important because the regulators, from both the FDA and the FTC, are under tremendous resource restraints, he said. “We’d like to see more enforcement as long as there are infomercials [airing] at 2 a.m. [advertising] a cure for AIDS and a cure for cancer,” Shao said, “or a supplement that can help you lose 50 pounds in three weeks without you doing anything. … This all has the effect of eroding consumer confidence.” Which in turn negatively impacts the sales of dietary supplements, Shao added.
In the past year, the NAD has reviewed more than 30 claims and has issued more than 25 recommendations, he said. In those cases where the NAD recommendations were not adopted by the supplement companies in question, they were referred directly to the FTC and the FDA, Shao noted. “[And the] FTC puts a lot of stake into what NAD does,” Shao said, suggesting that those NAD reports become a high priority for FTC enforcement.
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