WASHINGTON— The Natural Products Association (NPA) has submitted comments to FDA about the agency’s proposed information collection on the procedure for petitioning the agency for exemption from 100-percent identity testing of dietary ingredients under the dietary supplement Good Manufacturing Practice (GMP) regulations. FDA issued the notice on information collection on Nov. 28, 2014 and invited comments. NPA sent the agency a letter this week, applauding the agency’s decision to extend the information collection activities for future exemption petitions.
Late last year, FDA published a 30-day notice requesting comment on its proposed information collection activity. Specifically, the agency asked for comments on four topics:
- How collecting information (e.g. reports, records, etc.) from dietary supplement firms might provide a practical benefit and improve the agency’s handling of petitions;
- How accurate FDA’s assumption of the burden of collecting information would be;
- Ways to enhance the quality, utility, and clarity of the information to be collected; and
- Ways to minimize the burden of the collection of information on respondents, such as automated collection and other technologies.
However, the agency noted only three comments were submitted, and none addressed any of the four topics. The comment period expired—FDA said it was unable to issue public notice of the pending expiration—so the agency requested last month that the Office of Management and Budget (OMB) reinstate the proposal for collection of information on 100-percent identity testing exemption petition.
In its notice FDA reported receiving no such petitions for exemption and said it expects, if any, no more than one petition per year going forward. It further estimated companies working on such a petition could expect to take about eight hours to prepare all the necessary factual and legal information. Despite the lack of interest in petitioning for exemption of 100-percent identity testing of dietary ingredients, FDA reasoned extending the information process would help companies who decide to file a petition in the future.
“While the FDA has not received any new petitions to request an exemption from 100 percent identity testing of dietary ingredients, we expect the petition process to be used in the future," wrote Lauren Cohen, VP of public relations and communications for NPA, in the association’s letter to FDA.
Cohen further outlined key points NPA made in its comments to FDA on the petition process and oversight.
The letter stated NPA believes a consistent definition and goal of identity testing is critical to any guidance written for this petition process and will ensure the burden of the petition process is well understood. “We also ask that any discussion in the guidance on identity include the minimum ingredient identity characteristics and parameters that must be addressed and monitored in the petition process and what degree of variability in these areas is acceptable, and what systems to determine the variability are viable," Cohen wrote.
NPA further emphasized its steadfast belief GMPs are essential to ensuring the quality of dietary supplements for consumers and identity control procedures are a key part of assuring consumers what is on the supplement label is true and accurate. NPA noted it support of FDA’s interim final rule provisions that allow for an alternative to 100-percent identity testing, but the association stressed any exemption would have to be specific to supplier, manufacturer and ingredient in order to uphold the intent of the final GMP rule.
“We do not believe submitting a petition to request an exemption from 100 percent identity testing of a dietary ingredient is something that should be taken lightly, nor should such exemption be granted without exhaustive demonstration of both the supplier’s/vendor’s and manufacturer’s quality systems, specifically that knowledge of a given firm’s operating procedures could be used to provide such assurances comparable to 100 percent identity testing," the NPA letter stated.
NPA also acknowledged most of the supplement industry would not be able to take advantage of alternative testing via an exemption petition, due to expected set-up costs and liability issues.
Read NPA’s letter here.