FDA Begins Addressing GMP Concerns

NEWPORT BEACH, Calif.--The Food and Drug Administration (FDA) was bombarded with industry questions today about meeting the proposed standards for the federal good manufacturing practices (GMPs). Panelists representing FDA, law firms and industry consultants were on hand to answer stakeholders' questions during the National Nutritional Foods Association's (NNFA) Webcast and conference call, "FDA Dietary Supplement GMPs: What You Need to Know." Approximately 100 industry stakeholders listened in, including representatives from Arizona Nutritional Supplements, Indena, Cardinal Nutrition, Rainbow Light and NSF.

The meeting began with Scott Bass, of the law firm Sidley Austin Brown & Wood, reporting that those who will be most impacted by federal GMPs are raw material suppliers and private label manufacturers. "Another big impact these GMPs will have is for manufacturers to put in the bottles what the bottles say they have--which has not been the practice over the last few years," Bass said, adding it would be wise for companies to meet these federal GMPs now rather than three years down the line when they are supposed to go into effect.

Bass highlighted certain hot spots manufacturers and suppliers should be aware of when incorporating GMP practices. For example, at least one company employee may have to oversee quality control at a given facility. Also, relying on certificates of analysis for ingredient quality may not be as influential as they once were in terms of quality. Additionally, FDA will allow a manufacturer to label their products as GMP-compliant, but a manufacturer cannot say or imply that being GMP-compliant makes a product safer or more efficacious. Interestingly, FDA does not require expiration dates on supplements under the proposed GMPs.

Bass suggested FDA underestimated the costs that will bring a small company (500 employees or less) into GMP compliance. Currently, FDA reports the cost to be $100,000. Many disagreed with the cost assessment of testing ingredients and finished products. As one industry member said, he was going to write up exactly how much it would cost to test one of his products containing 35 ingredients. FDA encouraged others in the industry to do the same thing, and to submit comment on their findings.

Carl Reynolds, another panelist and a senior consultant at AAC Consulting Group, said, "These GMPs have the potential for being more rigorous than what was proposed by industry. They will be analytically intensive."

A Q&A session followed the presentation, and most questions covered what constitutes "scientifically valid" methods, which should be used when testing products under the new GMPs. Karen Strauss, consumer safety officer at the Office of Nutritional Products, Labeling and Dietary Supplements at FDA, as well as a primary writer and project manager for the proposed GMPs, stated methods reported in peer-reviewed journal articles and in various pharmacopoeias would be acceptable. However, some industry members brought up the fact that certain methods which may be scientifically valid are not necessarily industry-accepted. Strauss stated that was a valid concern, and to include that in comments for this rule.

Another point that many callers questioned was when analysis of a product should occur--at the raw material or finished product stage (especially since many ingredients do not have a scientifically valid testing method currently on the books). The answer from FDA was vague, since the agency is awaiting industry comment before setting many of these GMP guidelines in stone, but Strauss said, "Whatever you can test in the final form, do it then."

Concerns were also voiced regarding records and certificates of analysis. A question regarding FDA's authority to have access to company records was addressed since, under food GMPs, these records do not have to be accessible. However, Strauss stated that records for certain food areas--such as baby food--are. Strauss also reiterated the point that just having certificates of analysis will not meet GMP standards for ingredient quality.

For those who could not attend the conference, FDA mentioned four other events that will address GMP concerns. The first will be a public meeting April 29 in College Park, Md.; the second will be held May 4 in Secaucus, N.J., at SupplySide East; the third will be in Oakland, Calif., May 6; and a satellite teleconference is scheduled for May 9. More details on these meetings can be found at www.fda.gov.