Proposed GMP regs under fire

The three biggest industry trade associations have challenged the Food and Drug Administration (FDA) over what they characterise as ?redundant and punitive? requirements under proposed Good Manufacturing Practices (GMP) rules.

In particular, they are seeking to amend three requirements related to employee qualifications, facility equipment and testing of raw materials and finished products. The three groups—the American Herbal Products Association (AHPA), the Council for Responsible Nutrition and the National Nutritional Foods Association—presented the FDA with a dossier detailing their concerns in January.

The proposed rule includes requirements for designing and constructing physical plants, establishing quality-control procedures, and testing manufactured dietary ingredients and dietary supplements. Manufacturers would be required to test five areas: identity, purity, quality, strength and composition of ingredients and supplements.

The testing requirements are the area of greatest concern.

?It doesn?t make sense to us that we must test each finished batch of ingredients or supplements for all five things,? said AHPA president Michael McGuffin. ?We would rather shift the burden to the company bringing the raw material in—the supplier—rather than the manufacturer. It makes more sense for the supplier shipping it to 50 different companies to test rather than all the manufacturers each testing it. This is more reasonable and you still get the same outcome.?

Business impacts
?When it comes down to what?s going to affect the cost of your business, this GMP is as big as anything in DSHEA,? said Loren Israelsen, head of the Utah Natural Products Alliance, which helped the three groups draft their response. ?Small businesses in particular will really get blasted. It would kill small products in any company big or small.?

The FDA said its GMP proposal aims to help consumers get accurately labelled and unadulterated dietary supplements. ?Consumers should have access to dietary supplements that are accurately labelled and are free from contaminants,? said FDA commissioner Mark B McClellan.

The industry contends there isn?t a widespread adulteration problem, and points out the proposed testing standards to confirm unadulterated products are unnecessarily expensive.

?This industry requires novelty and innovation. We?re the nursery of the healthcare industry,? said Israelsen. ?We don?t want to become a Proctor & Gamble in a pharma model—they won?t even think about something if it doesn?t generate x-dollars a year. The FDA badly underestimated the cost and impact on businesses.?

Other disagreements
Another point of contention is the matter of employee qualifications, which for pharmaceutical companies require employees to have adequate training, education or experience, or any combination of the three, to reach the threshold standard for employment.

For dietary supplements, the qualification threshold does not mention the looser ?combinations thereof?. The supplements groups say this represents a higher standard for supplements companies than for pharmaceuticals companies.

The final disagreement is the proposal requiring calibrating instruments the industry says exceeds that for drugs.

?It could be an incredibly expensive additional expense without additional value,? said McGuffin.

The final GMP rule is expected to be published later this year.

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