In the dynamic and highly regulated world of food and beverage production, ensuring compliance with federal laws is a cornerstone of successful operations. Among the key players in the regulatory landscape, the Food and Drug Administration (“FDA”) stands out as a pivotal agency that safeguards public health. While many alcohol producers—such as wineries, breweries, distilleries, and mead manufacturers—are more familiar with the Alcohol and Tobacco Tax and Trade Bureau (“TTB”), understanding the FDA’s role is equally critical.
The FDA’s oversight extends far beyond traditional food products, encompassing non-alcohol ingredients, food safety standards, and even certain aspects of product labeling for alcohol beverages. This guide provides a robust overview of what the FDA does, how it works, and its impact on the food and beverage industry, with particular emphasis on alcohol producers.
Introduction to the FDA: A Key Public Health Agency
The FDA, established in 1906 under the Pure Food and Drug Act, is one of the oldest consumer protection agencies in the United States. As part of the U.S. Department of Health and Human Services (HHS), the FDA’s mission is to:
- Protect public health by ensuring the safety, efficacy, and security of food, drugs, and medical products.
- Enforce accurate labeling so consumers can make informed choices.
- Facilitate innovation to promote public access to safe and effective products.
For alcohol producers, the FDA’s involvement often lies in areas beyond alcohol content—focusing instead on non-alcohol ingredients, manufacturing practices, food labeling, and allergen disclosures.
FDA Regulations for Wineries, Breweries, Distilleries, and Mead Producers
Although alcohol beverage producers must comply with TTB regulations, many aspects of their operations fall under FDA oversight. Here are some of the most relevant FDA regulations:
1. Current Good Manufacturing Practices (“cGMPs”)
FDA enforces cGMPs under 21 CFR Part 117, which ensure that food and beverage facilities maintain sanitary practices during production. Key requirements include:
- Proper cleaning and sanitizing of equipment.
- Training employees in safe food handling practices.
- Preventing cross-contamination of allergens.
Why it matters: If your production involves food additives or non-alcohol components, these practices are crucial for avoiding contamination and recalls.
2. Food Facility Registration
Under the Food Safety Modernization Act (“FSMA”), any facility that manufactures, processes, packs, or stores food for consumption in the U.S. must register with the FDA. This applies to most wineries, breweries, and distilleries unless their operations are entirely exempt.
Action item: Register your facility through the FDA’s Food Facility Registration page to comply with federal requirements.
3. Ingredient and Allergen Labeling
Alcohol beverage labels must meet TTB standards, but any non-alcohol beverages or food products (e.g., flavored syrups, mixers, or non-alcohol beer) must comply with FDA labeling laws. Key requirements include:
- Listing all ingredients in descending order by weight.
- Disclosing allergens as defined by the Food Allergen Labeling and Consumer Protection Act (FALCPA).
Pro tip: Check out the FDA’s Food Labeling Guide for a comprehensive overview of requirements.
4. Acidified Foods
Some beverages may fall under the category of acidified foods, which are subject to specific FDA regulations to prevent botulism. These require:
- Submitting product formulations for FDA approval.
- Monitoring pH levels during production.
Learn more: The FDA’s Acidified Foods page offers detailed guidance.
5. Recalls and Traceability
FSMA emphasizes traceability to quickly remove contaminated products from the market. Wineries, breweries, and distilleries must:
- Maintain detailed records of suppliers and distribution chains.
- Develop a recall plan in case of contamination.
Centers at the FDA and Their Roles
The FDA operates through specialized centers, each focused on a different aspect of public health. Understanding these centers can help alcohol producers identify where to seek guidance. Below are some of these centers.
1. Center for Food Safety and Applied Nutrition (“CFSAN”)
- What it does: CFSAN regulates food safety, labeling, and standards. For alcohol producers, this department is the primary source of oversight for non-alcohol ingredients, food allergens, and nutrition labeling.
2. Center for Veterinary Medicine (“CVM”)
- What it does: Oversees animal feed and veterinary products. This department is less directly relevant to alcohol producers but may impact operations involving byproducts like spent grains used as animal feed.
3. Office of Regulatory Affairs (“ORA”)
- What it does: The ORA conducts inspections and enforces FDA regulations. Inspectors from this office evaluate facilities to ensure compliance with cGMPs and other standards.
- Why it matters: Alcohol producers must prepare for potential FDA inspections, especially if they handle food-grade materials or non-alcohol products.
4. Center for Drug Evaluation and Research (“CDER”) and Center for Biologics Evaluation and Research (“CBER”)
- What they do: These departments oversee drugs and biologics, not directly relevant to alcohol producers. However, facilities producing alcohol beverages with medicinal claims (e.g., herbal tonics) may fall under their purview.
5. National Center for Toxicological Research (“NCTR”)
- What it does: Focuses on research into product safety, including the effects of chemicals and additives in food and beverages.
Why FDA Compliance Matters
Failure to adhere to FDA regulations can result in significant consequences, including:
- Product recalls.
- Fines or legal action.
- Loss of consumer trust.
Ensuring compliance not only protects your customers but also safeguards your brand’s reputation.
How the FDA Works with Other Agencies
The FDA collaborates closely with the TTB to regulate alcohol beverages. While the TTB oversees alcohol content, production standards, and taxation, the FDA focuses on non-alcohol components, food safety, and general labeling issues. For example:
- A brewery using a new flavoring additive must ensure it complies with FDA food additive regulations.
- A distillery selling bottled water alongside spirits must meet FDA bottled water standards.
Why Alcohol Producers Should Care About the FDA
The FDA’s role in the alcohol production process might seem secondary compared to the TTB, but it plays an essential part in ensuring the safety and legality of your operations. From regulating non-alcohol ingredients to enforcing food safety standards, the FDA works to protect both producers and consumers. By utilizing the resources available on the FDA’s website and understanding the responsibilities of its various departments, alcohol producers can confidently navigate the regulatory landscape and focus on crafting high-quality beverages.
How Can Lindsey Zahn P.C. Assist your Alcohol Beverage Company?
If you’re an alcohol producer navigating complex FDA and TTB regulations, our experienced attorneys are here to help. From ensuring compliance with food safety laws to guiding you through labeling and facility registration requirements, we provide tailored legal support to protect your business. Contact us today to schedule a consultation and take critical steps to keep your operation compliant while focusing on crafting exceptional beverages.
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.