On July 26, the American Herbal Products Association submitted a petition to the U.S. Food and Drug Administration requesting reconsideration of seven points on the current good manufacturing practices rule. The requests and accompanying recommendations were made on points that AHPA considered confusing, contrary to public interest or damaging to dietary ingredient manufacturers with no corresponding benefit.
"It's important that everyone understand that the rule is the rule, and if you are in the business, you need to know it," said Michael McGuffin, president of AHPA. "We were careful not to say the final rule should be repealed."
However, AHPA's petition outlines several areas that, if modified, would better support the herbal industry.
"Some of the rule is contrary to public interest," McGuffin said. "For example, not requiring a packager of supplements to verify the identity of the products fails to provide adequate evidence of traceability."
AHPA recommended that packagers be required to either verify that the specifications for the product have been met or visually examine the product.
Similarly, under the current rule, no batch or lot number is required on the product packaging. AHPA also requested a revision of this part of the rule to increase traceability.
Other parts of the rule directly impact manufacturers, such as the requirement of two or more people — one to weigh or measure ingredients and the second to verify — to constitute a legal manufacturer.
"This came to my attention through a sole proprietor, a manufacturer of tinctures, who went out of business," said McGuffin. "There are other ways to double-check ingredients without two people in the room."
In the petition itself, McGuffin writes, "…it is inappropriate for this regulation to limit the firms that are allowed under federal regulations to manufacture dietary supplements in any way that immediately excludes any firm that employs only one person, even if such a firm is in complete compliance with every other element of the Final Rule."
Other requests include adding definitions for "manufacturing," "packaging," "labeling" and "holding" to the rule, as well as allowing for people to check label accuracy in addition to electronic or electromechanical examination.
"If I pull out a crystal ball and guess which points the FDA will give us, they will probably support us on the issues that are contrary to public interest," said McGuffin. (See Items 1-3 in the petition.) "As far as the others, we're confident the FDA will at least give us a good hearing."
McGuffin also said the rule is an important step in the evolution of herbal regulation.
"I think it had to happen," McGuffin said. "And given the other options that we've seen, both the industry draft that started this conversation and the FDA's proposed rule in 2003, this strikes some balance. We'll be working over the coming months to support implementation throughout a range of companies, from small tincture makers to manufacturers of hundreds of products, while staying in communication with the FDA."
Herbal manufacturing companies with more than 500 employees must comply with the final rule by next June, while most other companies will have until the end of 2008.