Anthony Anscombe

Regulating Botanicals in Food
The Federal Food, Drug, and Cosmetic Act requires that food manufacturers ensure the safety of their products and the truth of label claims made for those products. Over the past several years, FDA has expressed concern that botanical ingredients, while possibly appropriate for dietary supplements, are not proper in conventional foods.

The agency has warned food manufacturers that certain botanicals cannot be used in food because they are neither approved food additives nor Generally Recognized As Safe (GRAS) substances. FDA has also cited a number of unauthorized or unsubstantiated health, nutrient, and structure–function claims.

For a substance to be considered GRAS, there must be reasonable certainty in the minds of scientists that it is not harmful under its conditions of intended use; the data and information to establish this conclusion must be publicly available; and there must be a basis to conclude that there is consensus among qualified experts about the safety of the substance for its intended use.

The Code of Federal Regulations sets forth procedures by which a manufacturer can obtain FDA affirmation of GRAS status or obtain approval for a substance as a food additive. In most instances, the two procedures will be equally rigorous, and require scientific consensus based on publicly available data. Even where a substance is GRAS, it still must comply with any applicable food-grade specifications of the Food Chemicals Codex; perform an appropriate function in the food; and be used in a concentration no higher than necessary to achieve its intended purpose.

In recent warning letters, FDA has given the manufacturers an opportunity to submit data to establish GRAS status. However, obtaining FDA pre-market affirmation of GRAS reduces the potential that FDA will later conclude that a botanical ingredient is a food adulterant. In certain situations, formal FDA approval of an ingredient as a food additive or GRAS affirmation could be required.

FDA has not authorized any claims that botanical ingredients positively affect any disease state or health-related condition. It has also disapproved “nutrient” claims that do not pertain to ingredients that contribute to the value of nutrients recognized by FDA, or do not meet a number of other regulatory requirements. Unless a nutrient claim has been authorized by statute or regulation, manufacturers must obtain prior approval for that claim.

FDA allows food manufacturers to make “structure and function” claims, but prohibits claims that the botanicals diagnose, mitigate, treat, cure, or prevent a disease. FDA also requires that the structure-function benefit derive from the food’s “nutritive value,” defined as “a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.”

Over the past few years, several federal courts have struck down FDA regulations that restricted commercial speech more onerously than necessary to advance the government’s purposes. On May 16, 2002, FDA requested public comment on whether it could or should treat claims about foods any differently than claims about dietary supplements. A possible result of this process may be some liberalization in the types of claims that food manufacturers can make, as long as those claims are truthful and not misleading.

The regulatory future should continue to evolve as outlined in FDA’s January 2000 “Dietary Supplement Strategy.” FDA has already begun implementing an adverse-event tracking system that will improve the availability of health-effect information relating to botanicals. FDA should also clarify boundaries between dietary supplements and conventional foods. This will help manufacturers know what claims they can make.

For a variety of reasons, botanical ingredients have not typically undergone the type of large-scale prospective clinical study that usually determines the safety and efficacy of pharmaceutical products. As consumer and regulatory interest in botanicals persists, however, the amount and quality of scientific research should increase. As it does, the safety and efficacy of botanicals will become more clearly established or refuted, and the clarity of regulatory guidance should proceed apace.

Manufacturers contemplating the use of a botanical ingredient should very carefully evaluate the level of scientific support for its safety and its label claims, and should consider obtaining expert scientific and legal advice on how best to comply with FDA requirements. Careful prospective evaluation could save later, more substantial compliance costs.

Partner in the law firm of
Sedgwick, Detert, Moran & Arnold
Chicago, Ill.