GMPs could boost OTC credibility, but do proposals go far enough?

Drug Store News, April 7, 2003 by Michael Johnsen

The Food and Drug Administration last month officially proposed new Good Manufacturing Practices for the manufacture of dietary supplements. It is an idea the FDA has kicked around for the past couple of years, since a coalition of manufacturer associations partnered to draft the proposed GMPs, which were modeled after similar standards for the food processing industry. And upon implementation, which is expected to happen as soon as next year, the new standards might just provide a much-needed credibility to the category.

Under the FDA's GMP proposal, manufacturers will be required to evaluate the identity, purity, quality, strength and composition of all dietary supplement products. "This will provide for the first time new, high-quality, industrywide standards governing the manufacturing of dietary supplement products," commented Joseph Levitt, director of the FDA's Center for Food Safety and A p plied Nutrition center.

The boon for the industry will be in forcing a level playing field for all participants, noted Gale Bensussen, p resident of Leiner Health Products. "We're constantly ratcheting up the QC standards to make sure we comply with every known standard. ... What we are enthused about is that now there are rules, and everybody needs to play by them."

Indeed, nearly all participants in the dietary supplement industry welcome the new rules as a much-needed solution to the industry's image problems. "The events and what has transpired in the media since [the 1994 passing of the Dietary Supplement Health Education Act] only highlight all too well what can happen when an industry doesn't have the type of guidance that it needs, remarked Pharmavite's Paul Bolar, vice president of regulatory and legal affairs.

However, GMPs may not be the magic-bullet ingredient that will shift consumer press coverage positively. Indeed, there are many who feel the GMPs as put forth by the FDA aren't quite stringent enough.

Currently, the proposed dietary supplement GMPs address personnel, physical plants, equipment and utensils and are akin to the standards set for food production, which basically make sure the equipment's dean and there's no mold growing, observed Patrick Dunn, senior vice president of quality and regulatory affairs at Leiner. "We feel those areas could be strengthened because that does not address the issue of adulteration, whereas in drugs you have to go through validation to make sure that you never adulterate your drugs," he said.

But the new GMPs do not speak to the efficacy of dietary supplements. "It is perfectly possible to have something that is well-made that still doesn't do what it's supposed to do or could raise safety problems because the ingredient itself causes adverse reactions. This regulation is not designed to do everything," Levitt said.

That means the consumer press still will be able to question ingredients on issues of efficacy. Two articles in The all Street Journal, published the week after the FDA announcement, purported that the "so-called good manufacturing processes" would not do "much to help the consumer sort through the marketing hype of the $19 billion industry."

The biggest challenge posed by the proposed GMPs may fall squarely on the shoulders of smaller manufacturers as they bring their manufacturing practices into compliance.

For instance, Dunn cites an FDA estimate of the record-keeping burden that implementation of the GMPs creates for the industry, which amounts to 500,587 labor hours per year.

Understanding the realities of this added cost, a three-year window for implementation of the new regulations. "For other companies that take a less strict approach to their manufacturing controls, it's going to be a rude awakening," Bolar said.