Does the release of the final rule requiring current good manufacturing practices for dietary supplements plant the seeds for a strong, quality industry?
The answer from those hardy enough to read the 815-page tome is that it appears the US Food and Drug Administration produced a solid document that spells out a reasonable process that will improve quality and safety for consumers.
"Overall, I think it's a pretty balanced, fair regulation. I don't see too much in there that industry has to complain about," said FDA regulatory expert Marc Ullman, a partner with Ullman, Shapiro, Ullman law firm in New York.
Loren Israelsen, executive director of Salt Lake City-based United Natural Products Alliance, also gave the agency thumbs up after reading the whole regulation shortly after the FDA released it in June. He said its negative tone had changed dramatically since the last draft in 2003, when FDA received about 400 comments from the dietary supplements industry and others.
"I think FDA has to be commended — not for speed in this case — for being pretty thorough," he said. "They really did go through all the comments. They really did respond to many of the comments, and they said why they agree or disagree."
The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and finished products. It also includes requirements for recordkeeping and handling consumer complaints.
The FDA says the rule will prevent supplements from containing the wrong type or amount of ingredients, and will prevent contamination by substances such as bacteria, pesticides, glass and heavy metals. The GMPs would also help ensure products are properly labeled and packaged.
Most industry experts were surprised the rule does not encompass raw ingredient suppliers. Israelsen said there are likely a couple of reasons for that omission. First, some suppliers provide ingredients to a number of industries, particularly food, and were probably concerned about having to meet two different GMP regulations. Second, many ingredient manufacturers are overseas, and while the dietary supplement GMPs do apply to foreign business, there's no practical way the FDA could inspect and audit those facilities. The burden of quality and identification of ingredients falls on the supplement manufacturers, Israelsen said.
The regulation does have some wiggle room, according to Israelsen, when it comes to what scientific methods a company can use to verify identity, purity strength and composition of dietary supplements. "That's good news in that it gives a broader range of tools to work with. The challenge, however, is that you'll have the battle of the methods. We will now have to separate who is competent and capable and who is not," Israelsen added. "That is not easily done. A lot of companies are already following, or exceeding, these regulations. A number of companies have a lot of work to do."