Initial Trade Association Response to Proposed GMP's

Two weeks ago, the FDA issued proposed Good Manufacturing Practices (GMP) Standards for the Dietary Supplements Industry, opening a 90 day comment period.

With this document so important to the industry as a whole, we asked the trade associations to comment, based on initial examination of the FDA document, and to identify what steps they were intending to take to communicate with their membership, to the FDA and with each other.

(Council for Responsible Nutrition response provided by , Annette Dickinson, Ph.D., President)

(American Herbal Products Association response from AHPA Update March 10, 2003.)

1. Regarding the GMP guidelines recently proposed by the FDA, what specific actions does your association have planned to a) inform members, b) educate members c) build a better industry in a general sense?

CRN: CRN is planning a series of conference calls and in-person meetings for our member companies for the dual purpose of reviewing what the GMPs will mean for companies, and for garnering member company feedback in order to develop a comprehensive set of comments to submit to the FDA. In addition, we are alerting our member companies to similar types of meetings which might be useful for them. We have been, and will continue to be, in close contact with the other industry trade associations as we move forward in this process in order to share strategies and comments as appropriate. We also have publicly commended the FDA in numerous media interviews as we believe that a federally-enforced standard for good manufacturing practices will raise the bar for the whole industry, and will ultimately help re-build consumer trust in our products.

AHPA: AHPA will promptly develop forums for its members to review this proposal and to communicate any concerns that can assist our association in formulating comments to FDA.

2. What comments does the association have based on a preliminary assessment of the FDA document?

CRN: First, we are delighted that the proposed rule has been issued as this is an important step towards improving product quality, and allowing for fuller implementation of DSHEA. Overall we think this is a set of GMPs that is largely consistent with the draft the industry submitted in 1997. We do however anticipate there will be some specific areas that we may question or make alternate suggestions and we fully intend to provide the FDA with a substantive set of comments. CRN and our member companies are vested in this process and want to ensure that we use our knowledge and practical expertise in ensuring that the FDA finalizes a rule that is feasible for companies to execute, workable for the FDA to enforce, and stringent enough for consumers to be assured that they are getting high quality products.

AHPA: "It is truly unfortunate that the federal agency that is responsible for the manufacturing oversight of our members' products has chosen to distort the facts and failed to acknowledge industry¡¯s role in developing the first draft proposal that served as their basis for dietary supplement cGMPs. FDA has not owned up to their own failure to enforce the current regulations and has distracted any attention from the fact that it has taken the agency almost eight years to develop cGMP for dietary supplements. While I know we all need to 'get over it' and address the proposed new rules, it is also important for companies in this industry to be aware of the tenor of FDA's communication."

3. How do the guidelines 'help' the industry?

CRN: Most, if not all, of our member companies already abide by similar GMPs, but there are some "bad actors" that are not producing good products. By having federally-mandated GMPs in place, the FDA will have additional "regulatory teeth" to ensure that high quality products are being produced. As an industry, we have not done a good job of letting the public know that reputable companies are already abiding by GMPs, and consequently, the entire industry has been pulled down publicly to the lowest denominator. Now that the FDA is stepping up to the plate, we have another opportunity to let the public know that our industry does produce products to high quality standards.

AHPA: This action was greeted by the dietary supplement industry with both relief and disappointment. "AHPA has communicated our support over the past several years, and even our impatience, for moving this process forward. FDA's press release and accompanying documents that announced this action unfortunately included gross misrepresentations as to the current regulation of dietary supplements, while we know that dietary supplement manufacturing is currently governed by cGMP for food, and products are already required to be free of adulteration and to be accurately labeled."

4. Are the trade associations working together in any capacity on GMP's or other quality initiatives?

CRN: We are in constant communication with the other trade associations, and GMPs are a prime example of how we work together. Our industry is a complex one and each association represents a different niche of the industry and offers its own set of benefits to its member companies. Consequently, while it is important for us to all cooperate and work together for the common good, it should also be recognized that there is strength in diversity, as each association provides a clear focus on its own members' particular concerns.

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