Federal government rules to establish formal Good Manufacturing Practices for dietary supplements should be finalized by early in 2003, according to government officials. Since passage of the Dietary Supplement Health and Education Act in 1994, the industry has been working from food GMPs.

Long awaited by the supplements industry, the GMP rules will standardize manufacturing and set clear guidelines for safety, record keeping, sanitation and ingredient handling. The rules also will help bring credibility to supplement makers that have been criticized in the media for product quality by health advocates and consumer groups. Criticisms center around the notion that the industry is "unregulated." Government-sanctioned standards could negate this charge.

In early February, a U.S. Food and Drug Administration official said that the agency will publish proposed rules in the Congressional Record by the middle of 2002 and then take public comments for 90 days. The agency will then review all comments and publish final regulations early in 2003.

In a letter to a congressional oversight committee, Melinda K. Plaiser, associate commissioner for legislation for the FDA, wrote, "Publication of this regulation is one of our top priorities." The FDA has been visiting manufacturers around the country to learn more about how supplements are made.

The natural foods industry has been pushing the agency to establish the GMPs since 1994 when Congress passed DSHEA.

"This is important for the industry; it will finally give us a set of quality standards," said David Seckman, executive director and chief executive officer of the National Nutritional Foods Association.

In 1995 a coalition of industry trade associations submitted a draft GMP proposal to the FDA. In 1997 the agency published that draft as an advance rule proposal and asked for public comment. Since that time, Congress and the industry have been waiting for FDA to finalize the rule.

By 1999 the NNFA decided it couldn't wait any longer for the federal rules, so the organization established its own voluntary manufacturing guidelines. Since then, about 40 manufacturers have received NNFA GMP certification and about 60 companies are in the evaluation process. It's estimated that 1,200 companies in the United States manufacture dietary supplements.

Other groups have joined the quality and GMP certification effort. The U.S. Pharmocopeia offers GMP and product testing; NSF has joined with the NNFA to test for quality as well as manufacturing standards; and ConsumerLab.com tests supplements ingredients but not manufacturing processes. (See "New Certification Programs Address Dietary Supplements," NFM, January 2002.)

The FDA has been pressured by the supplements industry and by Congress since passage of DSHEA to write rules for good manufacturing practices. A letter from Rep. Dan Burton, R-Ind., written in late January seems to have pushed the FDA into committing to action. Burton is the chairman of the House of Representatives Committee on Government Reform, which has oversight jurisdiction over the FDA.

Burton's letter was harsh.

"FDA has stood by far too long, citing either budgetary constraints or internal review as an excuse for not promulgating these regulations more quickly," Burton wrote. "Given the other issues on which FDA staff have expended substantial resources, I am disturbed that over the last seven years career FDA managers apparently lack the ability or the desire to manage their resources in order to fully and appropriately implement DSHEA."

On Feb. 1 Burton received notice from the FDA that the preliminary rules would be completed by mid-2002.

Marc Ullman, FDA and Federal Trade Commission expert and partner in the New York City-based law firm Ullman, Shapiro and Ullman, expressed doubts about the release of the GMP standards.

"I hope they do happen," he said. "It's about time. DSHEA was what, eight years ago? Eight years to do this. If a company I represented took eight years to comply with something FDA asked us to do, someone would end up in jail. It's been a disservice to the industry; it's been a disservice to consumers."

Ullman says he fears the rule will be much like the proposed rule the organic industry faced in 1997, which generated roughly 275,000 responses.

"I think we're going to see a proposal that's going to generate a vast number of comments; the final regs are still going to be months or years down the road," he said. "We're either going to see something that's so loose that it's useless or that mimics the prescription drug regulations too closely. There are some things in the OTC drug regulations about what [manufacturers] should do in assuring quality in raw material that probably belong in GMPs for supplements, but I suspect we're not going to see anything that resembles it. It's either going to be too lax or too stringent.

"I'd be pleasantly surprised if we saw a real quality working document."

Natural Foods Merchandiser volume XXIII/number 3/p. 17