FDA offers to help industry draft guidance following Trump’s regulatory freeze

“FDA is not the only source of guidance documents on best practices for compliance with regulatory requirements”​ the agency notes in a Jan. 31 constituent update. “Associations or organizations associated with a specific industry and universities also draft guidance documents to capture the best practices to produce food, feed and other regulated products in a way that helps to ensure their safety in accordance with federal regulations.”​

The agency adds in the update that it “can be involved in a number of ways”​ in the creation of these guidance documents, “including providing technical advice, looking out for potential conflicts with federal regulations and sharing its experience and insights.”​

The agency’s offer could be a way for industry to glean insight into how FDA interprets the regulations and standards it enforces, despite the 60-day freeze on pending regulations and draft guidance documents signed by Trump Jan. 20. It also could be a way to advance progress on guidance documents even during the freeze.

While industry guidance might not hold as much water as those issued by FDA, USDA or other agencies, FDA notes in the update that they can influence the government’s policies in the long-term.

“Developing industry standards and best practices … can ultimately become part of an FDA guidance in the future,”​ the agency explains in the update.

5 tips for involving FDA​

While FDA is open to working with trade groups and association to create draft guidance documents, the agency still has a full plate and will not have the resources to help with every proposal.

To increase the likelihood FDA will become involved in an association’s guidance process, it recommends associations first define the scope of the guidance document. How broad the guidance is, the extent of the industry’s need for the information and the usefulness of the guidance to FDA down the line in addressing topics not currently or planned to be covered by the agency, all factor into FDA’s decision to become involved, according to the memo.

Next it recommends creating a working group of diverse experts who have relevant interest or expertise on the matter, such as food industry representatives, consumer advocates, researchers, retailers and others in the state of federal government.

At this stage, before the guidance document is drafted, associations can reach out to FDA’s Center for Food Safety and Applied Nutrition for technical assistance, which the agency emphasizes is not mandatory but can take many forms, including reviewing and commenting on draft guidance, participating in webinars and joining face-to-face meetings.

When drafting the guidance, FDA recommends authors make the recommendations “as specific as possible and be science and risk-based.”​ Quantitative and qualitative risk assessments should be used as well as advice from subject matter experts. Participants also should brace for multiple rounds of review, the agency says.

Once the core group of advisers and authors are happy with the draft, it should then be circulated to a wider audience for evaluation, including to state and federal regulators, before it is finalized, FDA recommends. After this larger group’s comments are reviewed the guidance likely is ready for distribution and could be linked on FDA’s website for all stakeholders, if appropriate.

When all is said and done, this process generally takes about a year, which is notably longer than the current regulatory freeze, but it is a way to engage with the agency and other stakeholders during the freeze and in the period of likely uncertainty following.