Cockroach Killer or Food Ingredient?

Linalool is considered Generally Recognized as Safe (GRAS) for use in human foods as a synthetic flavoring substance by the FDA under 21 C.F.R. § 182.60. This means that linalool can be used in foods and is considered safe by the Agency. In fact, linalool has widespread application from foods to cosmetics and other FDA-regulated products.

The ingredient’s alleged use in insecticide does not in itself make the ingredient dangerous or inappropriate for use in food. If it did, then even water, which has numerous applications outside of food uses, including insecticides, would be considered dangerous. In short, it’s a good headline and it would probably make any company wish they had already entered into a settlement, but that does not mean the ingredient is unsafe.

But is it “Natural”?

Although there is no current FDA regulation defining “natural”, the Agency has stated that it considers the term to mean nothing artificial – which isn’t saying much. The Plaintiffs best argument is probably that the GRAS regulation specifically notes that linalool is synthetic, which may well disqualify it from use with “all natural” claims. However, with no actual regulation to violate, the case may be somewhat more complex. For more information on “Natural” claims and FDA regulations, visit our previous article here.

In sum, La Croix is faced with a difficult situation, as the intricacies of food and drug law are not well understood leaving emotional headlines like “La Croix Sued Over Use of Ingredient Found in Cockroach Insecticide” to dominate the conversation. If you have any questions about labeling or ingredient regulations, please feel free to contact us at contact@sglawfl.com.

Beverages are considered a type of conventional food, which differ from dietary supplements in both labeling and the ingredients that are permitted. For example, beverages differ from dietary supplements in that the labels of these products bear nutrition facts panels, as opposed to supplement facts panels, and the products are also distinguished by claims made in labeling. For example, the Guidance document notes that beverages are intended primarily to “to quench thirst or otherwise provide a source of fluids (e.g., water, soda), provide nutritive value (e.g., milk, orange juice), or provide taste and aroma (e.g., hot cocoa).” Guidance at 6. By contrast, dietary supplements are products that are intended to supplement the diet and promote health in various ways. Accordingly, the claims that may be made in the labeling of beverage products are somewhat more limited than those made for dietary supplements.

In addition to differences in labeling, including claims, beverages differ from dietary supplements by the ingredients that are permitted. Under federal law, dietary supplements must contain one or more dietary ingredients, which include vitamins, minerals, herbs and amino acids. 21 USC § 321(ff)(1). As explained in the Guidance, “to be lawful for use in a conventional food, [an] ingredient must be used in conformity with a food or color additive regulation prescribing the conditions of its use in food, be GRAS for its intended use in food, or qualify for one of the other exceptions to the food additive definition.” Guidance at 7. Accordingly, the ingredients permitted in foods are more limited than those that may be used in dietary supplements.

In sum, whether a product is properly marketed as a beverage or a dietary supplement will depend on a number of factors, including labeling, intended use, and ingredients, among other things. Thus, when developing a product to bring to market or importing a product into the United States, it is important to ensure that these factors are considered to ensure that the product is properly regulated. If you have any questions about the differences between beverages and dietary supplements or how you can successfully market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

If the determination is finalized, PHOs, and in turn trans fat, would be considered a food additive subject to pre-market approval by the FDA. Specifically, pursuant to Sections 201(s) and 409 of the U.S. Food, Drug, and Cosmetic Act (“FDCA”) any substance that is intentionally added to food is a food additive that must be reviewed and approved by the FDA prior to its being added as an ingredient, unless the substance is GRAS. To be GRAS, there must be either a consensus among qualified experts, based on scientific evidence, that the substance is safe under conditions of its intended use or a common use of the substance in food prior to 1958. Pursuant to FDA regulations, the agency may determine that a substance is not GRAS and is thereby a food additive when it believes there is no longer a consensus about its safety.

Although PHOs have been commonly used as an ingredient in processed food since the 1950s and are considered GRAS by the food industry, the FDA has tentatively determined that PHOs should not have GRAS status because trans fat, an integral component of PHOs, is associated with serious health risks such as heart disease. According to the FDA, the common use of a food prior to 1958 is insufficient to support continued GRAS status if there is no longer a scientific consensus that the substance is safe for its intended use in food. Thus, common use of a substance in food prior to 1958, alone, is not enough for a substance to maintain GRAS status.

In conclusion, the notice is available for public comment for 60 days. The FDA has especially requested comments regarding the impact of the removal of PHOs on small businesses and the time it would take businesses to phase out the use of PHOs. For example, the removal of PHOs, and accompanying trans fat, may impact businesses by requiring companies to undertake product reformulations and relabel affected products in order to comply with the FDA’s determination, if finalized. If the FDA does make a final determination, the next step will be a notice in the Federal Register.

If you have any questions about this notice or compliance with food additive regulations or regulatory compliance generally, please contact us at contact@sglawfl.com.