There has certainly been a lot of regulatory upheaval thus far this year. But beyond the personnel reductions and changes, it seems that there has been a great deal more proposed regulatory change than actual change.
In fact, much of the actual change that is occurring has more to do with industry voluntarily taking steps than any regulation coming down. Let’s take, as an example, the “MAHA Report” from the Presidential Commission to Make America Healthy Again. The report goes into great detail on factors determined to be food or drug root causes of childhood chronic disease, but it sets no concrete action steps or recommendations beyond that of further research needed. In fact, only 15 of the 70 pages focused on food at all, and the areas that had seemed to have heavy focus from U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., such as chemical residues, heavy metals and food coloring, held little mention in the report.
Food dyes.
Food colors have taken on more prominence since the report. The initial focus began in March, when RFK held a meeting with top company executives asking the industry to be proactive in removing artificial dyes from foods. However, even with FDA announcement of a series of actions it was taking to phase out synthetic dyes from foods, the process was intended to “work with industry” to do so.
It is commendable that many large manufacturers have made very public statements about removing artificial colors from foods, and I thoroughly believe they are doing so. But there also are companies looking at the cost of natural colors, which are significantly more expensive than synthetic, and deciding to wait until a regulation comes out. So, while this is, thus far, the largest change occurring in the food industry this year (excluding personnel reductions), it is voluntary and being conducted primarily by those who can afford to do it and/or see consumer relationship value in doing so.
Ultra-processed foods.
Let’s jump back to the report and the food area on which it did focus: ultra-processed foods (UPFs). The report states that while UPFs play a key role in keeping people fed, their availability and typically lower prices have led to an over-reliance. The report provides no solid definition of ultra-processed nor recommends specific actions, though an FDA/USDA request for data and information to help develop a uniform definition was launched. With all the attention UPFs are getting from both the federal government and consumers, the food industry needs to closely watch and provide input whenever possible to help guide the definition and potential regulation.
GRAS.
Alot of attention was briefly placed on GRAS (FDA's Generally Recognized as Safe designation) in March, with HHS requiring that FDA review the process, particularly for self-affirmation. But we’ve not seen any further focus on that, or anything coming out about an alternative. Will self-affirmation be discontinued? Will all current GRAS substances have to get some sort of FDA review? Or will the initiative gradually sink lower and lower in the pending file?
Chemicals in food.
FDA did publish a proposed method for ranking chemicals in the food supply to prioritize post-market assessments for public comment. There has been some thought put into that, but it really is just the beginning of what will likely be a long process. The proposed tool only lists, and requests discussion on, criteria (both science-based and subjective) for scoring chemicals to set the priority of each for post-market review. The method does not go further to discuss the actual post-market review; it does not state the potential consequences of unsatisfactory reviews; and it does not appear to consider how all this will be conducted with continuing reductions in personnel and budgets.
Keeping health top of mind.
All this said, we know government momentum is generally slow — and a lot of other balls have been hefted into the air as well. While I don’t have high hopes that we’ll see much in the way of final deliverables before year end, we are seeing a singular focus on health and on “making America healthy again.” And as long as RFK is at the helm, that is not going to decline.
I recommend keeping health top of mind, staying in the know on what is being discussed and being proactive — while staying prepared for curveballs. In short: stay on your toes. This administration can — and does — pivot fast.
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