Functional Ingredients Challenge Food Industry, Elevate Need for Public Standards

Functional ingredients can easily cross the line when it comes to the regulatory scrutiny they attract. Over the years, the FDA has issued myriad warnings for ingredients that are either illegally marketed as drugs or are used in unsafe ways. For the agency, the effort to rein in unacceptable claims is a never-ending battle as marketers and food scientists continually push the boundaries, prompting regulators to take a closer look at novel products and the health benefits suppliers claim.

Regulating new ingredients and monitoring and assessing their health claims are difficult tasks as claims often blur the line between nutritional benefits and drug functionality. Additionally, concerns have been raised about commodity ingredients used in new products at levels that may exceed what is generally recognized as safe (GRAS) – such as the concentration of caffeine in new energy drinks.

Further adding to the regulatory complexity is a movement by some local authorities to limit GRAS ingredient intake. Two examples are a recent congressional inquiry into the safety of energy drinks when taken by children and New York City’s ban on large containers of sugary drinks. So even when the FDA has clear guidelines on what is acceptable and not, consumer and political pressures may lead the agency to take a second look.

But where does the agency draw the line on the benefits a functional ingredient can claim without violating the definition of a drug? In its guidance on complementary and alternative medicine (CAM) products, the FDA provides examples of how a functional ingredient may fall under the definition of CAM. For example, the guidance states:

“…if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for foods in the [Federal Food, Drug, and Cosmetic] Act and FDA regulations, including the hazard analysis and critical control point (HACCP) system requirements for juices in

21 CFR part 120. If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act.”

Similarly, the Act also makes clear how additives are defined as CAM products.

For instance, botanicals or enzymes added to foods may fall within the “food additive” definition under section 409 (21 U.S.C. 348) of the regulation, which makes it subject to premarket approval by the FDA. However, if it is considered GRAS by qualified experts, it is exempt. Any claims associating the substance with the reduction of a disease risk are considered health claims (defined in 21 CFR 101.14(a)(1)) that require premarket review by FDA.

The guidance also provides examples of how dietary supplements would be treated by the agency. It cites the example of a cranberry extract tablet used for urinary tract health. “…the cranberry tablets generally would be regulated as ‘dietary supplements’ under section 201(ff)(1) of the Act if they were labeled for use to ‘maintain the health of the urinary tract’ rather than ‘prevent urinary tract infections.’ The cranberry tablets would be regulated as ‘drugs’ under section 201(g) of the Act if they were labeled for use to ‘treat urinary tract infections’ even if they were labeled as dietary supplements.”

Although the guidance document provides several concrete examples of how ingredient manufacturers can market their products, the FDA also acknowledges it is unable to provide “detailed” guidelines for all food products. That means companies wanting to bring new functional ingredients to market must toe a blurry line that may or may not draw the scrutiny of the agency.