About GMP standards

Please read this entire page carefully, with special attention given to this statement: "NNFA is clearly not representing the best interests of all its members, and CFH is clearly a controlled opposition group that is not truly representing the best interests of consumers in a consistent fashion. Like any controlled opposition groups, NNFA and CFH appear on the surface to be representing their members interests, but when you look BENEATH the surface, another picture emerges. By paying memebership dues to NNFA, health food stores and small manufacturers are unwittingly participating in their own destruction, but they're too busy to realize it."

Then read this excerpt from an article titled "Making Sense of GMPs"

Currently, there are no federal good manufacturing practice regulations specific to dietary supplements. In general, the Food and Drug Adminstration (FDA) defines the term good manufacturing practices (GMP) as procedures in manufacturing of foods, drugs and medical devices that are designed to ensure production consistency.

GMPs are about maintaining manufacturing standards--they are not necessarily a guarantee that a product is safe. "GMPs are supposed to ensure that only what is supposed to go in a product is actually what goes into it," said attorney Marc Ullman with Ullman, Shapiro and Ullman. "They also ensure that the product has been manufactured in a sanitary environment." . . .

 . . . . The Dietary Supplement Health and Education Act of 1994 (DSHEA) authorized but did not require the FDA to adopt new federal regulations for GMPs for dietary supplements. Under DSHEA, the FDA can issue GMP regulations for dietary supplements that are modeled after food GMPs. A number of organizations developed a model for the regulations and passed it to FDA in late 1995. The sponsors were the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA) and the Utah Natural Products Alliance (UNPA).

"In DSHEA, Congress ordered FDA to model any specific GMPs for supplements on food GMPs," Ullman said. "The food GMPs [as opposed to pharmaceutical GMPs] had less rigorous steps to take against impurity--not every batch needs to be tested and record retention isn't as rigorous."

 . . . .Rather than waiting for federal GMPs, NNFA rolled out a GMP program in January, 1999. When its GMPs were put in place, NNFA required all of its members to comply; that policy is no longer enforced. According to the NNFA, the policy changed because its bylaws require that a new condition of membership cannot be created without the full vote of the NNFA membership, which had not been done. It has also added a disclaimer this year, which is used in conjunction with the NNFA GMP seal, that reads, "This seal certifies that the manufacturer of this product uses quality systems and procedures that comply with NNFA's Dietary Supplement GMP standards. The quality of individual ingredients, however, has not been certified." . . .

. . . "In a sense, the GMP that NNFA is promoting is simply a process for documenting the production process with no regard for the quality of the ingredients so long as they meet the company's written specification," said Stephen Ashmead, head of research and development at Clearfield, Utah-based Albion Labs. "I am concerned that there is no enforcement policy associated with the audit, and that certification is good for three years. Also, it is not known how FDA's guidelines will differ from NNFA's."

Another question is what does the presence of the GMP seal on a product mean to consumers? Some note that a lack of consumer education about the seal may confuse consumers about what it actually represents. "While the program is sound in theory, the implementation has left quite a bit to be desired," Sorkin said. "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 which help to ensure consistency. So if a product is of low quality, GMPs only ensure that it will be low quality every time."

According to Jarrow Rogovin, president of Jarrow Industries Inc., the NNFA's program blurs the distinction between "quality" and "raw material." The solution, he said, is to eliminate the logo. "As far as the NNFA having a GMP program goes, even the FDA hasn't convinced itself that it needs GMPs [for dietary supplements]," Rogovin said. It takes a great deal of time and money to meet the NNFA's standards, he added, and he believes that having NNFA's GMP seal on a product insinuates that the product is "co-branded." In addition, he said, some companies have standards that are higher than the NNFA's, so having NNFA's logo on all products makes them all look the same. . .