What the FDA Regulates vs. What the TTB Regulates: Key Differences for Alcohol Producers

/ Beer, Cider, Distilled Spirits, FDA, Food law, Mead, Sake, TTB, Wine / By

For alcohol producers, understanding the roles of the Food and Drug Administration (“FDA”) and the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) is critical. While both agencies play a part in ensuring the safety, quality, and labeling of alcohol beverage products, their areas of oversight differ. The FDA primarily regulates food safety and non-alcohol ingredients, while the TTB is the authority on alcohol content, production practices, and alcohol-specific labeling. Here’s a breakdown to help you navigate these regulations and maintain compliance.

The Role of the FDA and TTB in the Alcohol Beverage Industry

The food and beverage industry in the United States is one of the most heavily regulated sectors. If you’re in the business of producing alcohol beverages—whether you run a winery, brewery, distillery, or meadery—understanding which regulations apply to your products is essential for legal compliance, consumer safety, and brand integrity.

While the TTB primarily governs alcohol beverages, ensuring that all products meet requirements for alcohol content, labeling, and taxation, the Food and Drug Administration (FDA) plays an equally important, though often less understood, role. The FDA is responsible for food safety and non-alcohol components of beverages, like ingredients and additives. This creates a complex landscape for alcohol producers, who must adhere to regulations from both agencies to stay compliant.

In this post, we’ll explore what the FDA regulates versus what the TTB oversees, and we’ll give you examples of where their regulations overlap. This knowledge is crucial for producers in the alcohol industry to ensure that their products are safe, properly labeled, and compliant with U.S. laws.

The FDA’s Role in Regulating Alcohol Beverages

While the TTB is the primary authority for alcohol beverages, the FDA has jurisdiction over certain aspects, particularly when it comes to non-alcohol ingredients, food safety, and labeling.

  1. Ingredients and Additives: The FDA regulates non-alcohol ingredients in alcohol beverages, such as flavorings, preservatives, and sweeteners. If an alcohol beverage includes any ingredients or additives that are classified as food ingredients (like a flavored wine, mead, or a cocktail
    mixer), these must comply with FDA rules for safety, approval, and labeling. The FDA also oversees the safety of these ingredients, ensuring they are safe for consumption under the conditions they are used. For example, if your brewery adds fruit juice or natural flavorings to beer, those ingredients must be FDA-approved.
  2. Labeling Requirements for Non-Alcohol Components: Non-alcohol beverages (like non-alcohol spirits or a low-alcohol wine) must adhere to
    the FDA’s strict food labeling guidelines. This includes listing all ingredients in the product and disclosing any allergens according to the Food Allergen Labeling and Consumer Protection Act (“FALCPA”).
  3. Food Safety and Good Manufacturing Practices: The FDA enforces Current Good Manufacturing Practices (“cGMPs”), which set standards for sanitation, equipment cleaning, and employee safety to prevent contamination and ensure safe production methods. These are outlined in 21 CFR Part 117. This is especially important for craft brewers, winemakers, and distillers who may use additional food products (like fruits or spices) in their beverages or have non-alcohol components in the product. The FDA oversees how these elements are processed and handled.
  4. Acidified Foods: If a beverage falls under the category of acidified foods, it may be subject to FDA regulations to prevent foodborne illness, like botulism. The FDA requires that these products meet safety standards, including pH levels.

The TTB’s Role in Regulating Alcohol Beverages

The TTB, part of the U.S. Department of the Treasury, is the primary regulatory authority for alcohol beverages, overseeing the following:

  1. Production and Bottling Standards: The TTB regulates how alcohol beverages are made, bottled, and packaged, setting rules that ensure consistent production practices across the industry. For instance, TTB regulations cover the use of specific terms and enforce identity standards for certain types of alcohol, ensuring that terms are not misused on labels.
  2. Alcohol Content: The TTB is responsible for regulating and confirming the alcohol content in beverages. This includes ensuring that alcohol beverages, such as wine, beer, spirits, and meads, are labeled with the correct alcohol by volume (ABV) percentage and that production processes follow legal standards for alcohol production.
  3. Taxation and Excise Duties: The TTB regulates the taxation of alcohol beverages. Producers must pay federal excise taxes based on the amount and type of alcohol produced. The TTB oversees tax filings and collection.
  4. Labeling of Alcohol Beverages: The TTB establishes and enforces rules on alcohol beverage labels, including mandatory information (such as the name of the product, alcohol content, and producer details) and approved claims (e.g., “organic,” “gluten-free”). However, the TTB typically does not require the detailed ingredient listing that the FDA mandates for non-alcohol beverages. The agency also oversee claims such as age statements (for products like whiskey) and the approval of brand names and designs on labels to prevent misleading information. Although alcohol beverage producers must comply with TTB regulations, many aspects of their operations fall under FDA oversight.

Examples of Overlap Between FDA and TTB Regulations

There are several instances where the FDA and TTB regulate the same alcohol product or producer, especially when it comes to labeling, food safety, and ingredients. Below is an examples:

  1. Flavored Wine: A winery producing a flavored wine might be required to comply with both the TTB for alcohol labeling and formulation the FDA for the safety and disclosure of added ingredients (such as fruit extracts, flavoring agents, or preservatives). If the flavor is a compound flavor, it could contain added ingredients whose usage may be limited by FDA regulations.
  2. Hard Seltzer Produced from Brewed Sugar: A hard seltzer with sugar as its fermentable ingredient would fall under FDA’s labeling jurisdiction assuming the product does not contain malt and/or hops. However, the hard seltzer would still be subject to the excise tax requirements of the TTB.

Navigating Both Agencies for Alcohol Producers

For wineries, breweries, distilleries, and mead producers, understanding the regulatory framework that involves both the FDA and TTB is crucial to ensuring product compliance. While the TTB primarily handles alcohol-related issues such as taxation, alcohol content, and production standards, the FDA manages food safety, ingredients, and non-alcohol components. There are many areas of overlap where both agencies may have a role in regulating the same product.

Staying compliant with both agencies can be complex, but by understanding their distinct responsibilities and areas of jurisdiction, alcohol producers can avoid costly mistakes and ensure their products meet the necessary legal standards. If you’re an alcohol producer navigating complex FDA and TTB regulations, Lindsey Zahn P.C. is 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 Lindsey Zahn P.C. today for an initial discussion about your product and how we can assist: info@zahnlawpc.com or 929-ZAHNLAW.