In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding the regulatory authorities that oversee your product. This is not always as straightforward as it might seem, but we're here to guide you through it.
When it comes to regulating food and beverages on the federal level, several agencies are at the forefront: the Food and Drug Administration, ("FDA"), the United States Department of Agriculture ("the USDA") and the Alcohol and Tobacco Tax and Trade Bureau ("TTB"). The Federal Trade Commission ("FTC") is responsible for regulating the advertising and promotion of food products. Finally, state regulators also play an important role, and many states require licensure to manufacture, distribute or warehouse food products.
Most of the Time FDA is the Lead Agency . . .
The definition of "food" under the Federal, Food, Drug, and Cosmetic Act ("FDCA") is quite broad and as a result, the FDA regulates most food products. The FDCA defines food as:
- articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
As a result, FDA's jurisdiction is broad and much of the time, it will be straightforward that FDA is responsible for regulating your product. However, for products containing meat or alcohol (like beef or turkey jerky, or a fermented kombucha), it gets more complicated. Likewise, products that are regulated by FDA but that also make organic claims or non-GMO claims will also be subject to USDA jurisdiction.
. . . Unless the Product Is Meat or Poultry
In most cases, if a product is meat or poultry, the USDA, not FDA, will have primary jurisdiction over the product. However, this can vary based on the type of meat or poultry.
For example, under the Poultry Products Inspection Act ("PPIA"), poultry is defined as any domesticated bird. This includes domesticated chickens, turkeys, ducks, geese, and guineas. USDA also inspects some exotic species like ratites and squab, including emus! However, non-specified birds, such as wild turkeys, wild ducks, and wild geese, are all under FDA jurisdiction, with the result that turkey jerky will be regulated by USDA unless it is sourced from wild turkeys – in which case it regulated by FDA.
USDA is also responsible for regulating cattle, sheep, swine, goats, horses, mules, and other equines under the Federal Meat Inspection Act ("FMIA"). Non-specified red meats, such as bison, rabbits, game animals, zoo animals, and all members of the deer family, including elk and moose, are under FDA jurisdiction. Note that cultivated meat (aka cell cultured meat) is regulated both by FDA and USDA.
What About Mixed Products (e.g., Soups or Flatbreads with meat)?
For products containing poultry with other ingredients, the amounts matter. Products with less than 2% cooked poultry meat and less than 10% cooked poultry skins, giblets, fat, and poultry meat (limited to less than 2%) in any combination are regulated by FDA. Those with 2% or more cooked poultry and more than 10% cooked poultry skins, giblets, fat, and poultry meat in any combination are regulated by USDA.
This is similar for products containing other meats. Products with less than 3% raw meat, less than 2% cooked meat, alone or in combination, are under FDA jurisdiction. Those with more than 3% raw meat, 2% or more cooked meat, alone or in combination, are under USDA jurisdiction.
Wait, My Kombucha is an Alcoholic Beverage?
Alcoholic beverages are generally under the jurisdiction of the Alcohol and Tobacco Tax and Trade Bureau ("TTB"). Under the Federal Alcohol Administration ("FAA") Act, the TTB has regulatory jurisdiction over distilled spirits, malt beverages, and wine with a 7% or more alcohol content. This also includes denatured alcohols used for foods and other purposes. However, FDA regulates the labeling of some beers and wines that are under 7% alcohol by volume ("ABV").
Kombucha is an interesting example because it can cross between FDA regulation and TTB regulation. The name "kombucha" generally refers to a fermented beverage produced from a mixture of steeped tea and sugar, combined with a culture of yeast strains and bacteria. Some kombucha products may also have fruit juice or other flavors added during production. The combination of sugar and yeast triggers fermentation, which may produce a kombucha with an alcohol content. Importantly, regardless of the alcohol content of the finished beverage, when kombucha reaches 0.5% alcohol or more by volume at any time during the production process, when bottled, or at any time after bottling, the kombucha is an alcoholic beverage and is subject to TTB regulation. So be aware when developing fermented products, even if intended to be low alcohol.
Finally, determining who has jurisdiction is important here because if a product is regulated by TTB, the beverage maker must submit the label to TTB for approval before selling the product. On the other hand, FDA does not require pre-market label approval.
What About Claims?
Claims on product labels are generally regulated by the agency with product jurisdiction. However, there are exceptions for both organic and non-GMO claims which are regulated by USDA regardless of the type of product. And keep in mind that label claims are distinct from advertising and promotional claims, which are regulated by the FTC. Keep an eye out for a subsequent blog that will focus on regulation of product claims.
Why does this all matter? Because knowing who's in charge is a crucial first step. It's the foundation upon which you build your business, navigate the regulatory landscape, and ensure your product's success. With this knowledge, you'll not only conquer the regulatory maze but also ensure your new healthy food or beverage thrives in the market. Foley & Lardner's Food and Beverage Industry Team can help you get there.
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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.