The U.S. Food and Drug Administration proposed a new regulation on March 7 that will require supplements makers to abide by good manufacturing practices. The proposed rule will establish manufacturing guidelines and will ensure accurate labeling—validating identity, purity, quality, strength and composition—and guarantee that ingredients are not adulterated with contaminants. It will also require procedures for records that address consumer complaints about adverse reactions to supplements.
The rule was published in the March 13 Federal Register; public comments will be taken for 90 days after the date of publication. "These standards are long overdue," Sen. Tom Harkin, D-Iowa, said.
The proposed 547-page regulation should help eliminate guesswork for consumers trying to determine which dietary supplements are of high quality. The rule does not address whether dietary supplements are efficacious or safe.
Mark B. McClellan, M.D., the FDA commissioner, said, "Millions of Americans use dietary supplements every day, and we need to make sure they're getting the products they pay for." The rule allows for civil and criminal prosecution for manufacturers and suppliers who violate GMPs.
Industry reaction to the proposed rule was positive. Large supplements companies welcomed the rule—they have voluntary manufacturing and purity standards and say the FDA regulations will flush out shoddy companies that detract from the market. Small manufacturers—defined by the Small Business Administration as having fewer than 500 employees—will have up to three years to comply with the rule.
"It is important that a good manufacturing practices rule be finalized and enforced in order to raise the bar for the industry as a whole," said Annette Dickinson, president of the Council for Responsible Nutrition.
Loren Israelsen, executive director of the Utah Natural Product Association, said the new regulations may help filter out companies that are causing problems for retailers and supplements manufacturers. "We need to walk our talk, and get rid of bad products," he said. "It may be that we have to get smaller to get better."
He also called for the FDA to advance the rule as quickly as possible, "or a great opportunity will be lost and the FDA will have failed in one of its most basic responsibilities, which is to enforce the law fairly and equitably."
Michael McGuffin, president of the American Herbal Products Association, said, "We asked for these record-keeping rules. It tightens the threshold but it's not going to be hard to comply with them."
"We agree with what the FDA has done," said David Seckman, executive director of the National Nutritional Foods Association. "Once the regulations are final, they will strengthen consumer confidence."
The NNFA hosted a Webcast March 13 to address the proposed FDA GMPs. Scott Bass, partner at the Washington, D.C.-based office of Sidley, Austin, Brown & Wood, said some small manufacturers or retailers who sell private label products may not face the financial burden some industry members predict. "If you are putting a label on a bottle, you won't be subject to the same strict requirements" that manufacturers or raw material suppliers face.