If you’re a probiotic supplier or manufacturer in the United States, you may be feeling uncertain about the state of the human health market. Unpredictable tariff adjustments and shifting regulatory guidelines on topics like self-affirmed GRAS status are just a couple of the challenges affecting U.S.-based probiotic companies today. While conditions are always subject to change, it’s useful to have a baseline awareness of current market happenings so you’re prepared to navigate the road ahead—here’s what you need to know.
Potential Elimination of Self-Affirmed GRAS Status
If you’re not already familiar, there are currently two pathways to GRAS (generally recognized as safe) status for probiotic ingredients: self-affirmation and FDA review. If a company’s ingredients have self-affirmed GRAS status, the ingredients have been reviewed by internal experts, but the FDA has not been notified of their use in food, beverage, or probiotic/supplement products. An FDA-reviewed GRAS affirmation, on the other hand, occurs if the FDA is alerted via a GRAS notice and subsequently approves the ingredient.1
In early March 2025, the Department of Health and Human Services (HHS) released a statement sharing Secretary Robert F. Kennedy Jr.’s directive for the organization to “enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers”. The press release advocates for the implementation of required FDA notification in order for a new ingredient to be granted GRAS status. HHS says it aims to work with both Congress and the FDA on “completely [closing] the GRAS loophole” by ensuring current and future policy alignment with Secretary Kennedy’s stated goal.2
However, experts have speculated that eliminating self-affirmation of GRAS status would take a significant amount of time, if it happens at all, as the change would require congressional approval. Removing the self-affirmation option could also “slow industry innovation” and “add to the backlog at the FDA” that is forming due to staffing cuts, according to a statement made at the 2025 SupplySide Connect trade show by Devon Gholam, vice president of the wellness product consulting firm Step Change Innovations.3
Although there is reasonable doubt surrounding the plausibility of self-GRAS elimination, some companies are beginning to conduct an audit of their ingredients, identifying which are self-affirmed and submitting notices to the FDA to get ahead of potential slowdowns. Others are opting to replace self-affirmed GRAS ingredients with alternatives that have already been reviewed by the FDA.1
Tariff Adjustments and Exceptions
The recent tariffs set in place by the Trump administration are also affecting the human health market. Cal Bewicke, CEO of Ethical Naturals Inc., an ingredient supplier, says that “supply chains these days in almost all industries are multi-national… [As] long as these tariffs are in place, costs will be higher”. Indeed, many dietary supplement ingredients are imported from outside of the U.S., so probiotic manufacturers may face difficult decisions related to rising costs and the potential need to select new suppliers. Probiotic ingredient suppliers are in a similarly tough spot as they reckon with the possibility of losing customers due to the costs associated with tariff implementation.4
Not all human health ingredients will be affected by tariffs, though. In early April 2025, President Trump signed an executive order that included an annex of items designated as exempt from tariffs. This annex lists certain vitamins, amino acids, and minerals commonly used in probiotics and dietary supplements, such as Vitamin A, Vitamin C, and multiple B vitamins, including folic acid, niacin, and niacinamide. However, the majority of common probiotic ingredients may still be subject to a tariff-driven cost increase.5
In Times of Uncertainty, Choose a Trusted Partner
When the market landscape for probiotic suppliers and manufacturers is facing such turbulence, working with the right partner is crucial to business success. When you choose MDG as your probiotic provider, we’ll help you navigate changes in the marketplace so you can move your business forward with confidence, no matter what lies ahead. Check out our market page to learn more, and contact us today to speak with an expert.
MDG is the probiotic provider that helps you differentiate faster without the added risk of investing your own resources in the development process.
References
- Burdick, C. (2025, March 12). Is the FDA ending self-affirmed GRAS? What you need to know. Select Ingredients. https://selectingredients.com/blog/is-fda-ending-self-affirmed-gras-what-food-beverage-brands-need-to-know
- Department of Health and Human Services. (2025, March 10). HHS Secretary Kennedy directs FDA to explore rulemaking to eliminate pathway for companies to self-affirm food ingredients are safe [Press release]. https://www.hhs.gov/press-room/revising-gras-pathway.html
- Gelski, J. (2025, April 9). Dismantling self-affirmed GRAS faces uphill battle. Food Business News. https://www.foodbusinessnews.net/articles/28051-dismantling-self-affirmed-gras-faces-uphill-battle
- Schultz, H. (2025, April 14). Companies fumble for best course through stormy tariff waters. SupplySide Supplement Journal. https://www.supplysidesj.com/business-resources/untitled
- Schultz, H. (2025, April 4). Vitamins, some other ingredients exempted from tariffs. SupplySide Supplement Journal. https://www.supplysidesj.com/business-resources/vitamins-some-other-ingredients-exempted-from-tariffs
Note: This blog was published on June 12, 2025.
