GMP Proposed Rule Released

COLLEGE PARK, Md.--The Food and Drug Administration (FDA) finally released a proposed rule today to require current good manufacturing practices (cGMPs) for dietary supplement companies regarding the manufacture, packaging and holding of products. The proposed rule includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. Under the cGMP proposal, manufacturers would be required to evaluate the identity, purity, quality, strength and composition of their dietary ingredients, as well as dietary supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints related to cGMPs. The 547-page proposed rule, to be published March 13 in the Federal Register, is currently under review by industry stakeholders.

"Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels," said Secretary Tommy G. Thompson of the Department of Health and Human Services (HHS). "Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products they're paying for."

In FDA's press release, it used findings from ConsumerLab.com reports to discuss the labeling discrepancies of various dietary supplements: five of 18 tested soy and/or red clover-containing products were found to contain only 50 percent to 80 percent of the declared amount of isoflavones and, of 25 probiotic products tested, eight contained less than 1 percent of the claimed number of live bacteria.

FDA's release also cited numerous recalls in the industry due to mislabeled products, such as those with excessive amounts of lead or not enough folic acid.

"This has been on our A list for some time," said Joseph Levitt, the director at FDA's Center for Food Safety and Applied Nutrition (CFSAN), at a press conference held March 7, " and this is a very important step forward. This will provide for the first time new, industry-wide standards governing the standards of the manufacture of dietary supplement products."

Under the proposed rule, if adopted as proposed, certain quality problems would be addressed, including those products that are superpotent, subpotent, have the wrong ingredient, have a contaminant (e.g., drug, bacteria, pesticide, glass, lead), has a color or tablet size variation from batch to batch, or are mislabeled.

The proposed cGMPs would apply to all firms that manufacture, package, or hold dietary ingredients or dietary supplements, including those involved with the activities of product testing, quality control, packaging and labeling, and distribution. The proposed regulations also would apply to both domestic firms and foreign firms that manufacture, package, or hold dietary ingredients and dietary supplements for distribution into the U.S.

"What this regulation is trying to do is to ensure that these products are made in a consistent way--consistent quality, strength and composition," Levitt said. "This regulation is not designed to do everything, just one thing--to make sure that dietary supplements are well-made and that the list and quantity of ingredients are accurate."

According to FDA, the cGMPs would assist manufacturers in producing unadulterated and properly labeled dietary supplements. Manufacturers would also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading. With this proposed rule, FDA would have the authority to determine standards that firms should apply in production and labeling.

Under the cGMP proposed rule, manufacturers would also be required to employ qualified employees and supervisors; design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, and holding; establish and use a quality control unit and master manufacturing and batch production records; keep a written record of each consumer product quality complaint related to cGMPs; and retain records for 3 years beyond the date of manufacture of the last batch of dietary ingredients or dietary supplements.

In terms of consumer complaints related to cGMPS, companies must turn over these complaints to FDA if asked during facility inspections.

"Too often, consumers purchase dietary supplements based on inaccurate or incomplete information on what they are getting. This proposed regulation would require that dietary supplements provide accurate information on the type and amount of ingredients they contain and that dietary supplements are produced using safe methods, " said Mark B. McClellan, M.D., Ph.D., commissioner of food and drugs. "Consumers should have access to dietary supplements that are accurately labeled and are free from contaminants."

According to Stephen Straus, director of the National Center for Complementary and Alternative Medicine (NCCAM), the natural products research arm at the National Institutes of Health (NIH), "Since credible research studies cannot be performed using many of the current, highly variable products, these practices will also speed our ability to provide the public with more definitive data about the safety and effectiveness of popular dietary supplements."

To help small businesses ease into the proposed cGMP regulations, FDA is proposing a three-year phase-in of a final rule for all businesses. For those companies who do not become GMP-compliant within the proposed three-year period, they will be subject to product seizure and injunction.

What about those organizations that offered GMP services when federal GMPs were on the back burner? The National Nutritional Foods Association (NNFA) is one such group. "The government is not going to certify anybody [in terms of being GMP-compliant]," said David Seckman, executive director and chief executive officer of NNFA. "It will more or less be `this is the standard you have to meet to be in accordance with FDA's cGMPs.'" In the March 7 press conference, Levitt reported these organizations would still be instrumental in an advisory capacity to those companies needing to become cGMP-compliant. Levitt told INSIDER that those organizations-such as NNFA-"should be applauded" for their efforts in the face of stalled federal GMPs.

Seckman added, "We're appreciative that the proposed cGMPs finally came out, and if it results in making a more level playing field among dietary supplement companies, that's great." During the week of March 10, NNFA plans to have a Webcast regarding the proposed rule, where legal representatives and FDA are expected to attend.

FDA plans to hold two public meetings later this spring to discuss the proposed rule. The first will happen on the East Coast in College Park, Md., on April 29; the second will be in Oakland, Calif., May 6. "These meetings are for us to be able to describe what's in the proposal and get feedback, as well as to meet with small businesses [for their input]," Levitt said. "We want to make sure [the proposed rule] is communicated well." He added he hopes the proposed rule will help answer such questions as "Are the requirements adequate?" and "Are they well-focused?"

The proposed rule can be found at www.fda.gov/OHRMS/DOCKETS/98fr/96n-0417-npr0001-01.pdf. Written comments will be received for 90 days after the publication date of the proposed rule in the Federal Register and may be addressed to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.