For brewers exploring new paths to growth, the rapidly expanding “functional beverage” market has potential. This category is evolving from a niche segment to a mainstream phenomenon.  

A functional beverage is a drink that promises health benefits beyond hydration. Energy drinks being a trailblazing example. Others may offer benefits around gut health, stress relief, and mental clarity. These benefits are achieved by intentionally adding bioactive compounds, nutrients, or botanical ingredients designed to target certain bodily functions. 

While consumer interest in functional beverages is high, significant regulatory challenges exist for companies considering competing in this growing market.  

First and foremost, health claims are not allowed on beverages containing alcohol and regulated by the United States Tax and Trade Bureau (TTB) or the Food and Drug Administration (FDA). There are currently alcohol-containing beers in the market that consumers may perceive as healthier by the nature of their ingredients, but making explicit health claims on products containing alcohol is strictly forbidden. 

The FDA strictly regulates health claims on all other food and beverages to ensure that all claims are truthful, substantiated, and not misleading. Functional beverages are not required to have a health claim ,but if you plan to make a health claim, a thorough understanding of FDA regulations regarding such claims is critical to avoid the FDA’s legal authority to levy fines or require recall of misbranded products. 

The FDA considers a health claim as a statement that links a food or beverage or an ingredient with a disease or health related condition. The FDA categorizes health claims into four buckets: 

• Authorized Health Claims provide a link between food or ingredients and the risk of a disease. These types of claims must meet strict criteria and be authorized by an FDA regulation or based on an authoritative statement from certain scientific bodies. 
• Qualified Health Claims are based on emerging evidence of a relationship between a food or ingredient and a disease or health condition, but do not meet the strict standards of an authorized claim. In this case, the manufacturer can petition the FDA to use the claim. Qualifying language addressing the claim is required on the label.
• Nutrient Content Claims describe the level of a nutrient in a food. They’re allowed only when the FDA has authorized the claim and the label follows the agency’s regulations.
• Structure/Function Claims address general well-being or effects on the normal structure and function of the human body. For conventional foods, these types of claims do not require preapproval by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading. For conventional foods, disclaimers are generally not required.  

It is also important to be familiar with FDA regulations regarding nutritional fortification of food and beverages, informally known as the “Jelly Bean Rule.” These rules prohibit food and beverages that are considered unhealthy to make health claims because of being low in certain ingredients, such as fat or sodium, or fortified with certain levels of vitamins and nutrients. In general, carbonated and non-carbonated beverages are affected by the Jelly Bean Rule, depending on sugar content, caloric thresholds, and legal categorization. 

Lastly, producers of non-alcoholic beverages must comply with subparts A, B, D, E & F of 21 C.F.R. § 117 ; including cGMP and record keeping requirements, as well as FDA ingredient and labeling requirements. It is important to note that nutrient content claims, such as “free,” “high”, or “low” have strict quantitative definitions and must be authorized by the FSA. 

As stated above, health claims are not required on functional beverages, but if health claims are made, it is critical to understand the rules and regulations. 

• A Food Labeling Guide – Guidance for the Industry 
• Label Claims for Conventional Foods and Dietary Supplements 
• Guidance for Industry: Questions and Answers on FDA’s Fortification Policy 

Watch for a follow-up to this communication which will detail some of the production challenges involved in the manufacturing of functional beverages. 

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