Consumer demand for health and wellness products continues to be extremely healthy, with the U.S. dietary supplement industry valued at nearly $70 billion by some estimates. While consumers and businesses grapple with high costs and economic uncertainty, innovation in the nutraceuticals industry could be under threat at a critical moment.

The lines between food and supplements have long been blurry, with companies fortifying snacks, bars, and beverages with all sorts of ingredients traditionally found in supplement formats, including protein, fiber, vitamins and minerals, as well as herbal and specialty ingredients that may offer more targeted health benefits.

Under federal law — the Dietary Supplement Health and Education Act (DSHEA) — dietary supplements are a subcategory of food, so this crossover of ingredients is intuitive.

Now, the current administration is considering changes to improve oversight of food ingredients. That effort is laudable. However, eliminating the self-affirmed Generally Recognized As Safe (GRAS) pathway without first reforming the New Dietary Ingredient Notification (NDIN) process would risk stifling innovation in the supplement market.

For decades, stakeholders in the nutraceuticals industry have been grappling with how to navigate the regulatory system for “new” ingredients and weighing the most appropriate path to market.

The regulatory system was designed to balance consumer safety with access to health products that are clearly in demand. Of course safety must be paramount. But in a healthcare system still dominated by reactive “sick care,” timely access to preventive solutions is equally critical.

Reputable companies continue to invest in R&D to deliver products that meet consumer expectations for safety, quality, and efficacy. For many, GRAS has become the most practical route to market. Blocking this pathway without opening a viable NDIN avenue would harm both businesses and consumers.

In September, FDA responded to separate citizen petitions from the Natural Products Association and the Council for Responsible Nutrition regarding Beta Nicotinamide Mononucleotide (NMN), confirming that NMN is lawful for use in dietary supplements. FDA had previously attempted to block NMN from the supplement market, claiming it was first investigated as a new drug.

As industry continues to contend with the agency’s interpretation of DSHEA’s drug preclusion clause — the recent decision fails to address core structural problems — losing the GRAS path would not only stifle innovation but also restrict consumer access to the very health products they are demanding, undermining the public health goals regulators seek to advance.