The American Herbal Products Association is asking FDA to amend seven elements in its current good manufacturing practices for dietary supplements final rule, including clarifying that an ingredient manufacturer or supplier cannot be made subject to the rule based on how its customers use its ingredients.

"AHPA is not aware of, and believes that there has been no prior federal regulation for current good manufacturing practice for any type of food that includes a mechanism whereby a company that provides food ingredients can be required to conform to a specific finished food product cGMP depending on how its customers use its supplied ingredients," the trade group says in a ¹ petition submitted July 25.

The sections of the rule addressed in the petition are "potentially confusing," fail to "provide adequate insurance of finished product integrity or traceability," which impedes "the rule's intention to ensure dietary supplement quality," or "are unnecessarily prescriptive in a manner that could create substantial damage to manufacturers with no corresponding benefit," AHPA President Michael McGuffin and the group's general counsel, Tony Young, say.

AHPA also asks FDA to remove a potential loophole in the rule published June 25 that would allow companies which package products made by other firms to avoid some parts of the rules on verifying that product specifications are met (² Also see "Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing" - Pink Sheet, 25 June, 2007., p. 3).

Additionally, AHPA asks FDA to add definitions to the rule for the terms "manufacturing," "packaging," "labeling," and "holding;" to allow master manufacturing records to include a range of batch sizes rather than a specific batch size; and require batch, lot or control numbers that must be assigned to dietary supplements to actually appear on finished products.

The association also addresses elements of the rule concerning responsibilities required of supplement firm operators or employees. The petition asks FDA to remove language from the rule that would effecttively bar any single-employee companies from being in the supplement business and add appropriate options to ensure product quality even in such firms.

AHPA also asks FDA to amend the rule to allow personnel to conduct examinations, which the rule currently limits to electronic or electromechanical examination, for correct labels to qualify for an exemption to label reconciliation.

McGuffin and Young explain ingredient suppliers for food and beverage product manufacturers must comply with GMPs for manufacturing, packaging, or holding human food, because FDA's relevant regulation states the definition of food "includes raw materials and ingredients."

These suppliers are not required to comply with specific GMP elements applicable to their customers that manufacture food products, such as GMPs for thermally processed low-acid foods or for acidified foods, McGuffin and Young state.

However, "under FDA's interpretation," these same ingredient suppliers would be subject to the supplement GMPs if they have customers that "simply package" their ingredients "for sale as a dietary supplement," they say.

"AHPA disagrees with this interpretation, however, and believes that an ingredient supplier should have the same obligation to comply with [GMPs for manufacturing human food] regardless of the class of foods in which its customers use or package its ingredients," according to the petition.

McGuffin and Young acknowledge a "significant difference between" special food categories and dietary supplements is that a dietary ingredient can be packaged and labeled as a supplement product without any further processing.

"But this fact does not, in and of itself, provide a reasonable argument to transform an ingredient company into a dietary supplement manufacturer, or to establish its identity as a dietary supplement manufacturer after the fact of its customer's packaging of its ingredient as a dietary supplement," they say.

Further, they point out FDA's interpretation "will have the effect of requiring an ingredient company to conform to two different federal cGMP rules if it has some customers that package one of its ingredients as a dietary supplement and others that use that same ingredient in another food class - even though their various customers are using the exact same substance, and potentially the exact same lot of the substance."

- Malcolm Spicer (m.spicer@elsevier.com)

AHPA Petitions FDA To Amend “Potentially Confusing” GMP Rule Elements

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