Suppliers the world over will soon feel the economic and bureaucratic squeeze when dealing with US manufacturers, thanks to the long-awaited good manufacturing practices (GMP) proposal, unveiled by the US Food and Drug Administration in March and open for comment until June 11.
The rule would establish manufacturing guidelines and ensure accurate labeling—validating identity, purity, quality, strength and composition—and guarantee that ingredients are not adulterated with contaminants. It will also require record-keeping for consumer complaints about adverse reactions to supplements.
"Globally, this will have a major impact," said Loren Israelsen, president of the LDI Group in Utah, who helped draft the seminal DSHEA regulation in 1994. "US manufacturers will expect more of suppliers, they will be asking for more information on quality and source purity of raw materials."
Large supplement 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 with fewer than 500 employees will have up to three years to comply.
"If you're a high-end company who for years has felt disadvantaged and not rewarded, this will be your chance to take advantage of this opportunity," said Israelsen. "If you haven't been as rigorous in your GMP procedures, now's the time to get with it or find something else to do."
The 547-page proposal should help eliminate guesswork for consumers trying to determine which dietary supplements are of high quality. However, the rule does not address whether dietary supplements are efficacious or safe.
The regulations will push supplements closer to drug GMPs, despite the fact that DSHEA spells out that supplements should be treated more like food-grade products.
The GMPs are also clearly aimed at botanicals. Those suppliers will see the cost of doing business increase, predominantly from more rigorous quality-control record-keeping. This is likely to lead to a sharp increase in demand for third-party certifiers.
"We asked for these record-keeping rules," said Michael McGuffin, president of the American Herbal Products Association. "It tightens the threshold, but it's not going to be hard to comply with them."
Others are less confident. "If you have a boatload of botanicals, you had better know if it has herbicides, pesticides or heavy metals in it," said Israelsen. "The cost to ensure raw material quality will go up across the board and it will echo through the supply chain right to the shelf. It will also put people out of business, but if we're thoughtful and sensible we can manage it."