Functional Mushrooms: The Difference Between Regulation as a Food, Food Additive, or Dietary Supplement

By Charles Alovisetti, Sahar Ayinehsazian

Mar 3, 2023

Consumers are increasingly interested in incorporating functional or adaptogenic mushrooms into their diets due to their potential health benefits, such as boosting immunity, reducing inflammation, and promoting overall wellness. As a result, the functional mushroom industry has grown significantly in recent years, with an increasing number of companies offering adaptogenic mushroom-based products in the form of capsules, powders, ersatz coffees, teas, broths, and other food products. Given the wide variety of available products, producers and consumers should be aware of the significant differences in regulation between food, food additives, and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Food, Food Additives, and Dietary Supplements Are Regulated Differently

Foods and food additives are subject to the general food safety requirements under the FD&C Act, which include pre-market approval, good manufacturing practices, and labeling requirements. On the other hand, dietary supplements are subject to separate regulations under the Dietary Supplement Health and Education Act (DSHEA). These include labeling requirements and good manufacturing practices, but not pre-market approval by the FDA (though some dietary supplements may require prior notice to the FDA before sales can occur).

Functional mushrooms marketed as food additives must comply with the general food safety requirements under the FD&C Act, whereas adaptogenic mushrooms sold as dietary supplements must comply with the regulations under DSHEA. Additionally, how a product is marketed and labeled can affect the types of claims that can be made about the product. Understanding the differences in product types and applicable regulations can help the functional mushroom industry ensure that its products are marketed and sold in compliance with applicable laws and regulations.

Functional Mushrooms Are Not Food Additives

Functional mushrooms can be used as a food ingredient but are not defined as a "food additive" under the FD&C Act. The FD&C Act defines food additives as substances that are added to food for a technological purpose and includes categories such as color additives, flavorings, and preservatives. In other words, these are substances added to food to enhance its taste, appearance or other qualities, or to preserve flavor. Food additives include sweeteners, coloring agents, stabilizers, and emulsifiers. Yellow dye No. 5, which requires a warning label in Europe ("may have an adverse effect on activity and attention in children"), is an example of a permitted food additive in the United States. 

What is a Food and What is a Supplement Under the FD&C Act?

Under the FD&C Act, “food” is defined as “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.” This definition encompasses all substances intended for human or animal consumption, including raw ingredients, processed foods, and beverages. 

A“dietary supplement” is defined as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The FD&C defines “dietary ingredient” as any of the following substances: a vitamin, mineral, herb or other botanical, amino acid, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above substances.

The Form of Functional Mushrooms will Determine Regulation as a Dietary Supplement or as a Food

Adaptogenic mushrooms would need to be sold as whole food products, such as fresh or dried mushrooms, to be considered food under the FD&C Act. As whole foods, they would not need pre-market approval by the Food and Drug Administration (FDA). They would also not be subject to the labeling requirements and restrictions applicable to food additives or dietary supplements. However, functional mushrooms sold as whole food products would still need to comply with general food safety requirements under the FD&C Act, including sanitation, labeling, and food adulteration. Additionally, the mushrooms would need to be free from harmful substances, such as toxic chemicals, and meet any other applicable food safety standards. 

On the other hand, functional mushrooms sold as powders or pills, are more likely to be considered to be dietary supplements and subject to a different set of regulations. Some of the other product types—like drinkable products—are subject to some debate, considering current regulatory regimes, as they can be seen as liquid dietary supplements or beverages. 

Compliant Producers and Informed Consumers Create a Win-Win Situation

As the functional mushrooms industry continues to expand, it is of the utmost importance for both producers and consumers to understand the nuances of product types and applicable regulations. A firm grasp of these concepts will allow manufacturers to create a proper plan for product types, including product labeling and affiliated marketing, which will lend to operational success. Likewise, in understanding the different categories of consumable functional mushrooms, consumers can make informed choices and get the utmost benefit from all that these products have to offer.  

Have questions about adaptogenic mushrooms or other innovative food ingredients? Contact our Food, Beverages & Consumer Packaged Goods attorneys and specialists. Supported by our corporate, regulatory, and compliance teams, CGP companies of all stages can rely on Vicente. We can help you set up your company, raise capital, get licensed, set up contracts and agreements, maintain regulatory compliance, and engage in M&A transactions.

The content and links provided on this page are for informational purposes only and not for the purpose of providing legal or tax advice. Viewing this page does not establish an attorney-client relationship. You should consult with a qualified legal professional for advice regarding any particular issue or problem. The contents of this page may be considered attorney advertising under certain rules of professional conduct.