Making Sense of GMPs

Making Sense of GMPs

Currently, there are no federal good manufacturing practice (GMP) regulations specific to dietary supplements. In general, the Food and Drug Administration (FDA) defines the term GMP as procedures in manufacturing of foods, drugs and medical devices that are designed to ensure production consistency. The idea is to maintain manufacturing standards, not necessarily to provide a safety guarantee."

GMPs are supposed to ensure that only what is supposed to go in a product is actually what goes into it," said Marc Ullman, a partner in Ullman, Shapiro & Ullman. "They also ensure that a product is manufactured in a sanitary environment."

While the Dietary Supplement Health & Education Act of 1994 (DSHEA) authorized FDA to adopt federal regulations for GMPs for dietary supplements, it did not require that the agency do so. Under DSHEA, such GMPs would be modeled on food, rather than drug, GMPs. "Food GMPs vs. pharmaceutical GMPs have less rigorous steps to take against impurity," Ullman said. "Not every batch needs to be tested and record retention isn't as rigorous." DSHEA mandated that FDA's GMPs would require companies to ensure quality control through written record keeping and the faithful monitoring of manufacturing operations. Written records would validate safety, purity and potency of ingredients.

Currently, dietary supplement companies are required to follow food GMPs, and many manufacturers have set up their own internal GMPs to use as a template for quality standards. Such set ups can feature in-house labs, scientific and technical staff, and testing capabilities.

Also, the National Nutritional Foods Association (NNFA) in January 1999 rolled out its own GMP program. While it was mandatory for all members when the program began, it has since become a voluntary program and has a disclaimer for use with its seal to let consumers know that GMPs ensure quality procedures, not the quality of individual ingredients. The program has been surrounded by controversy since its implementation and continues to be a subject of heated discussion.

Companies that have become certified tout the benefits of the certification. "We've needed this for a long time in the industry," said Jodi Drexler with Country Life. "[Certification] is a grueling process. It's more than having clean floors and machines. It's making sure that what you say is in the product is actually in it."

Other companies have questioned the implementation of the program and use of a logo. "While the program is sound in theory, the implementation has left quite a bit to be desired," said Harlee Sorkin with Traco Labs/SKW. "The NNFA GMP program indicates that products bearing its logo are safe, and that implies a certain level of quality. In fact, GMPs provide no assurance of the quality or safety of a product; they simply set guidelines for production that help ensure consistency. So if a product is of low quality, GMPs only ensure that it will be low quality every time."

Finally, there has been the question of why an internal industry program is needed if there is no federal program in the works. "The FDA hasn't convinced itself that it needs GMPs for dietary supplements," said Jarrow Rogovin, president of Jarrow Industries Inc. Rogovin said an industry GMP seal may only confuse customers about quality levels of different supplements. "A logo from an organization that represents small, independent health food stores could be seen on the shelves of mainstream drugstores and supermarkets," he said.

The federal program may be moving forward at last; according to a spokesperson at FDA, issuing a proposed rule on GMPs for dietary supplements is a "priority for this fiscal year." According to industry members, on Nov. 8 the proposed GMPs reached the White House Office of Management and Budget to receive one more review before they were to be published in the Federal Register. Because of their importance, the regulations were drafted by FDA and have been reviewed by the Department of Health and Human Services. After receiving word that OMB had the proposal, several industry trade associations promptly wrote to the agency urging that the proposal be published. Many of these associations said they have been in discussion about GMPs for dietary supplements and are hopeful the agency will come forward with a program similar to the 1995 industry draft GMPs.

In the meantime, it is the responsibility of retailers and manufacturers to question up the chain of supply about the quality procedures being followed. "A GMP is a baseline," said Michel McGuffin, president of the American Herbal Products Association. "Quality control is a part of that, [but] there is still no 'right' way to ensure internal quality control."

Excerpted from the Sept. 18, 2000, issue of Natural Products Industry Insider. For the complete version, visit www.naturalproductsinsider.com/articles/091gmpfoc1.html.

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