We often receive inquiries about whether the Food and Drug Administration (“FDA”) has control over alcohol beverage products. This is a pertinent question, and the answer is not always straightforward.
The FDA’s jurisdiction over alcohol beverage products depends on the type of product and the specific circumstances. For instance, the FDA can have labeling jurisdiction on some beer and wine labels, but it does not have primary authority over spirits labels. This is in contrast to food safety, where the FDA regulates all aspects of food products, regardless of whether they fall under the agency’s labeling jurisdiction.
Understanding the FDA
The FDA is a federal agency that oversees a wide range of consumer products. The FDA holds primary jurisdiction over traditional food products sold in the United States. Food is broadly defined and encompasses items such as cookies, bread, pasta, and juices. The FDA is empowered to ensure the safety and proper labeling of all food items available in the market. In short, the agency is responsible for the safety of foods and possesses the authority to take action regarding adulterated or misbranded food products, including alcohol beverages, whether they are domestically produced or imported.
A food product is deemed “adulterated” if it has been manufactured, packaged, or stored under unsanitary conditions, contains harmful substances that could endanger health, or includes unapproved food additives. The FDA can initiate actions such as seizing adulterated products, including alcohol beverages, and can seek injunctions against the introduction of these products into interstate commerce. In the case of imported products, the FDA can refuse entry to items that it deems adulterated or misbranded.
Are Alcohol Beverages Required to Comply with FDA Labeling?
Generally speaking, no (with some exceptions, such as ensuring ingredients are safe for use in alcohol beverage products).
However, there are specific situations where alcohol products are subject to FDA labeling regulations (i.e., where the FDA has primary jurisdiction over the labels of these alcohol beverages). In these instances, the product must carry labels similar to those found on traditional food products. For example, the label would be required to include a nutrition facts panel and an ingredients statement. Typically, items like the nutrition facts panel and ingredients statements are not mandated by the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) (although similar panels and ingredient statements can be voluntarily added to a label within TTB’s jurisdiction provided they adhere to TTB regulations). However, when the product falls under the FDA’s labeling jurisdiction, the situation changes.
Which alcohol products need to adhere to FDA labeling regulations? They typically fall into two categories:
- Wines with less than 7% alcohol by volume (ABV) which are often referred to as low-alcohol wines. This can also include hard ciders, meads, sake, etc. provided that the alcohol content is under 7% ABV.
- Beers made from substitutes for malted barley (e.g., sorghum, rice, sugar, or wheat) and beers made without hops.
How Does FDA Labeling Differ?
Apart from aesthetic differences and the requirement for a nutrition facts panel and other mandatory statements, FDA labeling significantly differs from TTB labeling. Notably, there is no pre-market approval for labels within the FDA’s jurisdiction. This means that the FDA does not review a product’s label before it enters the market. While this may expedite the product launch process, it also introduces a risk for food manufacturers and brand owners: the risk of having an incorrect label, the FDA discovering this label, and subsequently taking regulatory action, such as issuing a warning letter.
This underscores the importance of diligence for wineries and breweries whose products fall under the FDA’s labeling jurisdiction. Careful attention to FDA labeling requirements is essential to avoid potential regulatory issues and increased costs. We always advise manufacturers to have their labels reviewed by professionals familiar with FDA’s rules and regulations before the product goes to market. This can help preempt problems when selling the product.
Because the TTB requirements are fairly different from those of the FDA, it is advisable to work with an industry professional who can review proposed labels and advise on potential pitfalls and risks. Reach out to Lindsey Zahn P.C. at info@zahnlawpc.com or 929-ZAHNLAW for guidance.
How Can Lindsey Zahn P.C. Assist With FDA Labeling for Your Alcohol Product?
Lindsey Zahn P.C. can reviewing your product and label before you launch it into the market. We have worked with producers of low-alcohol wines and FDA-regulated beers as well as traditional food labels and advised them on proposed new products, labels, and routes to market.
Our experience stems from our work with both the FDA and TTB, giving us a comprehensive understanding of how each agency operates and overlaps, particularly in the realm of alcoholic products. We offer various types of label reviews for these products, from preliminary assessments to detailed label examinations.
If your alcohol beverage product falls under the FDA’s labeling jurisdiction, we highly recommend working with an industry professional who understand FDA regulations before bringing your product to the market. Reviewing FDA labeling rules can be a complex and time-consuming task. Contact Lindsey Zahn P.C. today for an initial discussion about your product and how we can assist: info@zahnlawpc.com or 929-ZAHNLAW.