The Food and Drug Administration (FDA) will begin sorting through industry's comments on its proposal on good manufacturing practices for dietary supplements, with closure today of the comment period.
The proposal, published in May, has been welcomed in general, but trade associations say numerous changes need to be made to prevent new regulations from presenting huge financial pressures on supplement makers.
The National Nutritional Foods Association (NNFA) says that while the guidelines will help to build consumer confidence by setting standards, the proposed rule would place undue burdens on suppliers as a whole and smaller dietary supplement manufacturers in particular. While the FDA estimates costs to be up to $100,000 (€88,320) to bring a firm into compliance, the industry suggests this is a significant underestimation.
The final GMP rule will put up to 250 supplement manufacturers out of business because they will not be able to afford to comply, said NNFA, which submitted its final comments last week.
"This is unacceptable as products supplied by these companies are vital to the diversity, quality, and affordability of dietary supplements," said a NNFA release.
Other areas that have to be addressed in the proposal include when analysis of a product should occur - at the raw material or finished product stage? While it is likely to be closer to the end product, some raw materials suppliers, such as soybean processors, are also closely involved in production of soy and other health ingredients.
The Council for Responsible Nutrition has in turn carried out a comparison of the current report, the GMPs for food, those for drugs and the industry draft GMPs submitted to FDA in November 1995 and published by the FDA in 1997 as the ANPR on dietary supplement GMPs.
The comparison identifies those portions of the rule that are virtually identical tothe food GMPs and so could be omitted from the document,and some areas in which the drug GMPs or other provisions appear to have served as themodel. The comparison also points to some provisionsincluded in the industry draft published as the ANPR that have been omitted from the current FDAproposal, including a number of provisions that would have required written proceduresfor key operations and that would have provided for expiration dating or other featuresconsidered essential to the marketing of today's dietary supplements.
Some of these should berestored to the proposal on the grounds that they are essential to a company's ability todevelop and maintain a well-controlled production process or to manufacture and marketproducts acceptable in today's business environment, says CRN, which publishes the report on its website.
NNFA's comments on the GMPs are in the Members Only section of its website.