“This is a case of regulatory mission creep,” said Daniel Fabricant, PhD, president and CEO of NPA. “Why are we required to provide more and more information, but we can’t find out if a company, say a competitor in China, is selling from a registered facility?”
“If we can’t use the information FDA collects to protect our own industry, why should we comply with a requirement that could disadvantage US industry?” Fabricant told NutraIngredients-USA.
NPA made its views known via comments filed on the federal docket. The call for comments on the proposal opened in mid November and closed January 14. The proposal, titled “Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of U.S. Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products,” can be viewed here.
While the deadline has passed, the comments docket itself has not been populated as a result of the federal government shutdown.
Which countries are asking for info?
In the proposal, FDA mentioned that it maintains lists of companies seeking to export such products, which include dietary supplements, to China and the European Union. NPA said FDA should be transparent about which countries specifically are asking for information on US exporters, and precisely what information is shared with those governments.
“It is our guess that not all European nations require this information, and U.S. companies have a right to know, out of transparency, which countries are asking for this list and which ones are not. NPA would also like to know what other information FDA is sharing in its own databases with foreign governments. U.S. companies have a right to know what information is being communicated to foreign entities as it relates to administrative actions (e.g. warning letter), inspection outcomes (NAI, VAI or OAI status) from FDA’s Compliance Management System (CMS), or enforcement actions (e.g. injunction or seizure),” NPA stated in its comments.
NPA also noted that some information FDA is proposing to collect from companies under this procedure is already in FDA’s possession, such as facility registration numbers, date of last inspection and so forth. Asking manufacturers to resubmit such data is a waste of time, the organization maintained.
NPA: FDA would act as screening service for other countries
NPA also argued that the FDA proposal amounts to the agency acting as an eligibility screening service for foreign governments. This goes beyond the agency’s regulatory remit, NPA said.
In the proposal, the agency said that in addition to the information it is calling for to be included on the lists, foreign governments may require additional information.
“NPA requests FDA release the documents and requests submitted to the Agency from each foreign government entity as to new implementing requirements for that importing country. Furthermore, there are numerous third-parties performing certifications for foods and dietary supplements. FDA should provide a list as to what third-party certifying bodies and certification programs each foreign government is looking for as well as FDA’s criteria for what it determines to be an eligible third-party certification that can be used toward inclusion of a company’s name in a list for foreign governments,” NPA said in its comments.
And in its comments, NPA noted that US industry cannot access information collected under the 2002 Bioterrorism Act (see Fabricant’s comment above) but will willingly share this information on US companies with foreign governments.
”This appears that FDA is catering to the wishes and demands imposed on it from foreign governments while being less than transparent with non-government organizations (NGOs), associations, other stakeholders, and the public within the U.S.,” NPA’s comments stated.
Fabricant noted that the proposal seems to run counter to the Trump Administration’s overall goal to lessen the burden of regulations on US industry. It’s unclear how long this registry proposal has been under development, so it could be a legacy of the previous administration, he said.
“Some of these might be hangover issues, or it might be a case of unintended consequences,” he said.