Bioterrorism education vital for industry and FDA , says AHPA
changes to the way the FDA is implementing regulations against
bio-terrorism. Since then, several other food organisations,
including the American Herbal Products Association (AHPA), have
voiced their concerns about this legislation, reports Philippa
Nuttall.
Michael McGuffin, president of the APHA, supported demands by the GMA for an extension of the educational period - granted to allow companies time to get used to the workings of the new system, while making sure that there was minimum interruption to the flow of trade - but wanted the FDA to go even further.
"The points that the GMA makes are all valid,» he told NutraIngredientsUSA. "It is important to the industry that the educational elements of the revised system are only maintained but enhanced."
Furthermore, he believed that the education process should not be limited to the food industry, but extended to the FDA.
"Because the rules have changed so quickly and because many additional inspectors have been hired or reassigned, many of the agency's personnel have not been properly trained in how the import regulations should be enforced," said McGuffin.
To back up this assertion he cited that fact that: "Numerous AHPA members have had their import shipments of herbal ingredients detained because the inspector had misclassified the product."
McGuffin gave two examples of this happening. First, the "misclassification of lobelia as a 'new dietary ingredient'". Hence, suggesting it was not marketed in the US before 1994 and that a "significant body of scientific information" would have to be submitted before the herbal could be brought into the country, "even though this ingredient was sold here for many decades before 1994".
The second example was the «misclassification of a heat-processed powdered extract of citrus peel imported for use in foods as an unprocessed medicinal product and therefore subject to rejection for import."
McGuffin clarified that neither of these issues was directly related to the new bioterrorism rule, "but because the level of scrutiny has increased markedly many more import lots are subject to review".
The FDA issued the interim final rule for prior notice in December 2003 and full enforcement of the bioterrorism act is expected to begin on 13 August.
Last October, when the bioterrorism act began to come into force, the AHPA prepared a document to help members understand registration requirements and prepared a draft template communication for companies to use to inform their foreign suppliers of the need to register. The association also offered - for a fee - to act as the US agent for international members and foreign suppliers to domestic members.
