UNITED STATES

Fortification of Foods
(Suzan Onel)

The U.S. Food and Drug Administration (“FDA”) policy on the fortification of conventional food products can be found at 21 CFR 104.20. This policy establishes a uniform set of principles that is intended to provide a framework to guide manufacturers in deciding whether and how to add essential nutrients to fortify conventional foods intended for sale in the United States. The principles of rational fortification expressed in the policy are to: (1) correct a dietary insufficiency, (2) restore nutrient levels to those prior to storage, handling, and processing, (3) provide a balance of vitamins, minerals, and protein in proportion to the total caloric content of the food, and (4) prevent nutrient inferiority in a food that replaces a traditional food in the diet. Under the FDA’s fortification policy, the indiscriminate addition of nutrients to food is discouraged, and the FDA considers it inappropriate to fortify certain foods, including fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. FDA continues to actively monitor and enforce its fortification policy against foods that are fortified inappropriately and those making inappropriate nutrient content claims that imply fortification.

Additional information on FDA’s fortification policy can be found in an FDA Guidance called, Questions and Answers Regarding Fortification Policy(2015). The FDA Guidance is not binding but provides useful information as to FDA’s current thinking.

Cannabis as an ingredient in food or supplements
(Suzan Onel)

Since 2018, cannabis and cannabis-derived ingredients have become increasingly common in food and dietary supplements sold in the United States largely due to the statutory removal of “hemp” from the definition of marijuana. However, “cannabis” is not a defined term or otherwise carved out of the Federal Food, Drug, and Cosmetic Act (“FDCA”). As a result, these ingredients remain regulated by the Food and Drug Administration (“FDA”) under its existing statutory and regulatory authorities for foods and dietary supplements, just like any other ingredient.

To date, FDA has stated it has “no questions” on GRAS notifications for specified uses of hulled hemp seed, hemp seed protein powder, and hemp seed oil. However, FDA has concluded that THC and CBD may not be added to conventional foods based on 21 U.S.C. § 331(ll), known as the “prior drug exclusion.” That provision prohibits the distribution or sale of food (including animal foods and feeds) containing the active ingredient in an approved drug product or a drug for which “substantial clinical investigations” have been undertaken and where the existence of such investigations has been made public. Other cannabis-derived compounds that have not been previously approved as drugs, or subject to “substantial clinical investigations,” are theoretically not prohibited from use in foods under the prior drug exclusion clause, but the food additive provisions of the FDCA pose significant barriers to entry.

FDA’s position regarding the use of cannabis and its derivatives in dietary supplements generally parallels its stance for use in food since the “dietary supplement” definition in 21 U.S.C. § 321(ff), contains a provision that is nearly identical to the above referenced prior drug exclusion clause.

In January 2023, after convening a high-level internal working group to explore potential regulatory pathways for cannabidiol products, FDA concluded that the existing statutory and regulatory framework for foods and supplements do not provide a path forward for most of these ingredients under the applicable safety standards and looked to the U.S. Congress for legislative assistance in this regard. Currently, the FDA is prioritizing its enforcement attention on products that are labeled or advertised for therapeutic or medical uses because: 1) they may induce patients to disregard approved therapies and 2) their safety and effectiveness have not been established.

Other authorities with jurisdiction over the production, sale, and marketing of cannabis and cannabis containing products include, on the federal level, the Drug Enforcement Administration (DEA), the U.S. Department of Agriculture (USDA), and the Federal Trade Commission. There is further complexity on the state level where there are differing, and in some cases contradictory, laws on testing, packaging, labeling.

 

Country-of-Origin Marking and Labeling Requirements
(Sarah Brew)

  • CBP Country-of-Origin Marking. The United States Customs and Border Protection Agency (“CBP”) regulates country-of-origin labeling with respect to all goods imported to the United States, including food. Specifically, Section 304 of the Tariff Act of 1930 (19 U.S.C § 1304), as implemented by 19 CFR Part 134 of the Customs Regulations, requires every good of foreign origin (unless excepted), or its container, imported into the United States, to be conspicuously marked in a manner that will indicate the good’s country of origin (“COO”) to the ultimate purchaser.
The COO is the country where the product is manufactured, produced, or grown prior to entering the United States. There are various rules governing COO markings. For example, for goods imported from a country that is a party to a preferential trade agreement (e.g., North American Free Trade Agreement (NAFTA) countries, such as Canada or Mexico), the framework to determine the COO relies on whether a “tariff shift” has occurred. See 19 CFR Part 102. Determining whether a “tariff shift” has occurred is an extremely fact-specific analysis that should be made on a case-by-case basis.
For goods imported from any other country that is not party to any applicable preferential trade agreement, the framework evaluates whether a “substantial transformation” of the product has occurred to determine the origin of the good. See 19 CFR 134.1(b); see also 19 CFR 134.1(d). A “substantial transformation” is based on a change in the name, character, and use of a good that differs from that which it possessed prior to processing and is applied on a case-by-case basis. Additional information on the tariff shift and substantial transformation processes is available here.
  • USDA Country-of-Origin Labeling. Additionally, the United States Department of Agriculture (“USDA”), through the Agricultural Marketing Act of 1946 (7 U.S.C. §1621 – 1638d), requires retailers (primarily gro-cery stores and supermarkets) to provide country-of-origin labeling (“COOL”) information for “covered commod-ities,” which include muscle cuts and ground portions of chicken, lamb, and goat meat; fresh and frozen fruits and vegetables; wild-caught and farm-raised fish and shellfish; raw peanuts, pecans, macadamia nuts, and gin-seng. Retailers must convey COOL legibly and in a “conspicuous location” where customers are likely to read and understand the COOL (e.g., “on a placard, sign, label, sticker, band, twist tie, pin tag, or other format that al-lows consumers to identify the country of origin of the product”). 7 U.S.C. § 1638a(c). Additional infor-mation on USDA’s COOL requirements is available here.

Vegan & Vegetarian (Sarah Brew)

  • Vegetarian. U.S. regulations do not currently define “vegetarian.” However, “vegetarian” products are com-monly understood to mean products that do not contain the flesh of any meat (e.g., pigs, cows, bison, exotic meats), poultry (e.g., chicken, turkey), fish, or shellfish. Unlike vegans (as discussed below), many vegetarians consume byproducts of animals, such as milk, eggs, and honey. Additional information on vegetarianism is available here.
  • Vegan. Veganism is a form of vegetarianism. As with “vegetarian,” U.S. regulations do not currently define “vegan” claims. Pursuant to guidance from informal vegan sources and third-party or private authorities, such as the American Vegan Society, however, “vegan” products do not contain any food products or by-products derived from animals or animal by-products, including meat, fish, shellfish, dairy, eggs, honey, etc. Cer-tain other ingredients that are typically considered non-vegan include ingredients such as vitamin D3, casein, certain types of non-vegan sugar, honey, by-products of the fishing industry, etc.

Suzan Onel

Suzan Onel
USA
KLEINFELD, KAPLAN & BECKER


SARAH BREW

SARAH BREW
USA
FAEGRE BAKER DANIELS LLP


 

This is general information rather than legal advice and is current as of 30 May 2024. We recommend you contact a specialised food lawyer for legal advice for your particular circumstances to support commercial decisions which could impact your product or business.