Despite being led by a lame duck commissioner, the FDA ended 2024 with a flurry of regulatory activity that carried over into January. USDA was busy earlier in the year. Food & beverage processors in the year or two will have to deal with ingredient bans, new labeling rules and a long-discussed change to the FDA’s pre-market ingredient approval process, Generally Recognized As Safe.
That is, if the sweeping changes across the federal government being undertaken by the Trump administration do not reverse these initiatives. In their defense, most of the regulatory actions and plans had bipartisan support and had been demanded by Congress for years.
One partial reversal has already occurred. The FDA’s new definition of “healthy” originally had an effective date of Feb. 25, 2025, but on that date the Health and Human Services Dept. (HHS), FDA’s parent, delayed the rule until April 28 to abide by Trump’s freeze on all new federal regulations, so the new administration can review its necessity.
Will the new administration revisit and change things that the previous administration finalized? “That has to be considered in a case-by-case way,” says David Joy, a partner in law firm Keller and Heckman, who spent nearly 15 years at FDA. “It’s difficult to picture the ban on Red 3 getting changed for several reasons. In the event that the new administration wants significant new restrictions on foods that can be called ‘healthy,’ they would most likely need to put them through notice and comment rulemaking.”
So, with that caveat, here are the key regulatory changes scheduled to be enforced this year or next. Consider this a to-do list or at least a to-start list for 2025.
FDA ingredient bans
Going back to July of last year, the FDA revoked the authorization of brominated vegetable oil (BVO) in food. “The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health found the potential for adverse health effects in humans,” the agency wrote.
BVO is a vegetable oil that is modified with bromine. It was used in small amounts to keep the citrus flavoring from floating to the top in some beverages. Few beverages in the U.S. still contain BVO, the FDA said, so the deadline for enforcement comes up more quickly than other regulatory changes, with enforcement beginning this Aug.2.
California was responsible for forcing the FDA’s hand on BVO, as the stabilizer was included in a list of ingredients that will be banned in the Golden State effective Jan. 1, 2027. Potassium bromate, propylparaben and infamous Red Dye No. 3 also are on that list, so start removing or looking for replacements for those if you plan to sell in California.
On Red 3, FDA reacted a little more slowly but still came up with a ban of the colorant, effective Jan. 15, 2027. The federal agency dragged its heels a bit, citing studies that showed the mechanism that caused cancer in rats after ingesting Red 3 was not present in humans, but public sentiment and Congressional pressure won out.
California also passed a ban on Red 40, Blue 1 & 2, Yellow 5 & 6 and Green 3, as well as Red 3, from all foods served in state schools, effective Jan. 1, 2028. The old FDA administration indicated it was at least reconsidering those ingredients, and an RFK Jr.-led HHS may provide the final push. We have a useful guide to natural replacements for all those color additives here.
The FDA on Jan. 6 released voluntary limits on maximum allowable lead levels in baby foods to reduce potential developmental and neurological issues in infants and young children. The limits are 10 parts per billion for fruits, vegetables, grain- and meat-based mixtures, yogurts, custards or puddings, and single-ingredient meats, packaged in jars, pouches or tubs. Dry cereal and single-ingredient root vegetables thresholds will be 20 ppb.
The voluntary limits are called “action levels,” limits beyond which “the FDA may regard the food as adulterated under the Federal Food, Drug, and Cosmetic Act,” according to the agency announcement.
Only lead was covered, not other heavy metals such as arsenic, mercury and cadmium, and the guidance is only voluntary. But with a heightened sense of urgency from leadership at FDA, HHS and Congress, rules for the other heavy metals could come this year.
USDA’s war on pathogens
The Agriculture Dept. continued its war on salmonella with a declaration the pathogen’s presence in poultry – both chicken and turkey – is an adulterant. The nuance of that means the agency can immediately demand a recall once it detects the pathogen, not go through the pleasantries of discussing a potential recall with the processor.
Similarly, USDA’s Food Safety and Inspection Service (FSIS) last April declared salmonella an adulterant in raw, breaded, stuffed chicken products, such as chicken kievs, which consumers have a bad habit of not cooking properly (they’re not microwavable!). Enforcement of that rule starts May 1.
Perhaps motivated by the late-2024 deaths of two infants from listeria, FSIS on Dec. 17 announced several steps to strengthen the agency’s oversight of food processing facilities that make ready-to-eat products. This Jan. 17, the agency was to add broader listeria species testing to all samples of ready-to-eat product, environmental and food contact surfaces and to increase testing of facilities.
Long-term initiatives
Processors should be in the final stages of preparation for the January 2026 enforcement of the FDA’s Food Traceability Rule (FSMA 204(d)). The final act of the landmark Food Safety Modernization Act of 2011, it requires enhanced tracking and tracing systems for classes of foods. Although it does not mandate electronic traceability, it will be difficult for processors to prove they have effective tracking and recalls without computerized records.
The rule was finalized three years ago, so all food & beverage processors should be preparing for it. But the food industry has been urging FDA to delay its implementation. With the effective date in the past but the enforcement date in the future, it’s hard to say if this regulation could be undone by the new administration.
The FDA on Nov. 21 sent a proposal to the White House’s Office of Management and Budget that would require front-of-package nutrition labels for foods and beverages, part of an effort to make it easier for consumers to choose healthier products and hopefully reduce chronic disease in the U.S. – a priority for new HHS Secretary Robert F. Kennedy Jr. and his Make American Healthy Again campaign.
The proposed rule was just published in the Federal Register on Jan. 15, and the wording says the requirement would not take effect until at least three years after approval. The agency is still accepting comments at www.regulations.gov.
Called the Nutrition Info box, it would detail the relative amounts of three nutrients—saturated fat, sodium and added sugars—in a serving of food and would appear on the package’s front. The proposed label looks a lot like the black-and-white Nutrition Facts box carried on the back of most foods.
It's only a proposed rule at this point; its compliance date would be three years after the final rule’s effective date for businesses with $10 million or more in annual food sales. Businesses with less than $10 million in annual food sales would have an additional year to comply.
The FDA in December tackled an issue it’s been asked to do for years: What exactly is a “healthy” food? The voluntary rule, at least as of this writing, has just two components. To use the “healthy” claim, a food product needs to:
- Contain a “certain amount” of food from at least one of the specified food groups (such as fruits, vegetables, fat-free and low-fat dairy etc.) recommended by the Dietary Guidelines.
- Adhere to specified limits for saturated fat, sodium and added sugars.
Those "certain amounts" and limits, in terms of "food group equivalents" include:
- 1/2 cup of vegetables or fruits (with less than 2% of the daily value [DV] of added sugar, 10% of the DV of sodium and 5% of the DV of saturated fats.
- 2/3 cup of dairy (with less than 5% of the DV of added sugar, 10% of the DV of sodium and 10% of the DV of saturated fats).
- 3/4 oz. of grains (with less than 10% of DV of added sugar, 10% of the DV of sodium and 5% of the DV of saturated fats). Servings of meat, seafood, eggs, legumes and nuts or seeds also are recommended.
There are many more specific foods and limits in the Federal Register notice.
Two interesting inferences from the rule: Some products that have been considered healthy in the past no longer qualify. Those include fortified white bread, highly sweetened yogurt and highly sweetened cereal. And there are a handful of foods that did not qualify for a healthy claim before but now can – generally, foods that have “good” fats (monounsaturated), such as “nuts and seeds, higher fat fish such as salmon [and] certain oils. In a bow to household budgeting and practicality, some peanut butters and canned fruits and vegetables also qualify.
Last December, the FDA and USDA released a joint Request for Information (RFI) about food date labeling, primarily usage of terms such as “Sell By,” “Use By” and “Best By.” Both food processors and the public can submit comments. But this subject has been debated occasionally for 10 years, so it’s questionable any rule will be formed this year.
One of the oddities that surfaced in recent scrutinies of the FDA is its difficulty in banning an ingredient or additive once that chemical was certified as safe, or at least acceptable – even if that safe finding occurred decades ago.
In a public hearing last Sept. 25, agency officials said they’re developing a “systematic process” for conducting post-market assessments of chemicals in food. This involves ingredients considered generally recognized as safe (GRAS), such as food additives and color additives, as well as food contact substances and naturally occurring contaminants such as lead and arsenic.
Since that initiative is just in its formative stages, it remains to be seen how the new administration will affect it.
