Regulatory freeze could change or delay implementation aspects of FSMA, Nutrition Facts rule

By Elizabeth Crawford

- Last updated on GMT

Regulatory freeze could change or delay implementation aspects of FSMA, Nutrition Facts rule

Related tags Nutrition facts label Nutrition Food and drug administration

The Trump Administration’s regulatory freeze announced last week could significantly impact how the Nutrition Facts Label final rule and regulations related to the Food Safety Modernization Act are interpreted and enforced even though they passed well before the memo, food and drug attorneys warn.

The memo released Jan. 20 freezes new and pending regulations, with some notable exceptions, until an official designated by the president reviews and approves them if they have not yet been published in the Federal Register, and if they have but are not effective yet temporarily postpones them for at least 60 days “to allow for a review of questions of fact, law, and policy that the regulations raise​.”

And while the Nutrition Facts Label final rule and regulations published in 2015 and 2016 related to FSMA fall outside of these bounds, pending guidance documents related to them do not. Nor do any other agency statements “that set forth a policy on a statutory, regulatory or technical issue or an interpretation of a statutory or regulatory issue,”​ lawyers with Covington & Burling’s Food & Drug Practice group note in an alert issued Jan. 23.

The inclusion of guidance and interpretive documents in the memo is where Trump’s directive differs from an otherwise similar one issued by the Obama Administration in 2009, and as such creates “other avenues through which the administration could change or delay or impact documents that have been issued or that the food industry expects to be issued,”​ said Jessica O’Connell from Covington & Burling.

She told FoodNavigator-USA that the memo could impact draft guidance documents recently issued related to how fiber and added sugar will be handled in the implementation of the Nutrition Facts Label final rule for which FDA currently is collecting comments.

The administration also could consider pushing back the compliance deadline for the new Nutrition Facts label from its current date of July 26, 2018, O’Connell suggested, noting the industry has been vocal about claims that the two-year timeframe was insufficient given all the requirements in the final rule.  

Additional guidance expected on FSMA also could be delayed, she said.

In the dietary supplement world, the draft new dietary ingredient guidance issued in August could be detoured once again, she warned.

She explained the “huge number of comments submitted”​ on the NDI guidance will now be viewed through the lens of the new administration and it is difficult to know if it the new leadership will reevaluate some of the positions and policies in the guidance and re-issue another draft, which would be a lengthy process, or simply revise the first draft and stay the current course until it is finalized.

Other potentially impacted food regulations

Beyond the potentially delayed guidance documents, the freeze could impact USDA’s final rule on animal welfare and avian living conditions under the organic program, even though it was published the day before Trump took office because its effective date is until March 20, according to Covington & Burling’s alert.

FDA’s proposed rule to remove GRAS affirmation for partially hydrogenated menhaden oil and partially hydrogenated rapeseed oil, which have been stuck at the Office of Budget and Management since July 2016, also could be impacted, although O’Connell says it is a “peripheral”​ as FDA already decided PHOs are no longer GRAS.

An advance notice of proposed rulemaking on implementing the national bioengineered food disclosure standard from USDA also could be impacted, although it could be spared as it is subject to a statutory deadline, which was one of the exceptions to the freeze, the Covington & Burling alert notes.

Other exemptions include regulations related to emergency situations or other urgent health, safety, financial and national security matters. The memo also does not stop agencies from working on new regulations or impact open comment periods.

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1 comment

Timing of things...

Posted by Brandon Griffin - Ingredient Identity,

Lots of unknowns to be sure. However, two years to update a nutritional facts panel for a given product is plenty of time, whether you do it manually or have some software to generate it. Even if you have a lot of SKU's and even if additional testing is going to be required, food laboratories can accommodate capacity for larger batches of samples to be certain, but there is cost to that. The planning and cost of printing re-printing labels is something to consider for certain. And while the new NDI draft guidance is only still a draft, the different proposed parts identified are being noted already as requirements for any will be interesting to see over the next two years if Self-determined GRAS ingredients are increasingly targeted.

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