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Registrar Corp

World's Leading FDA Compliance Experts

Alcoholic Beverages: Guide to FDA Registration and Compliance

Mar 31, 2022

The U.S. Food and Drug Administration (FDA) shares responsibility with the Alcohol and Tobacco Tax and Trade Bureau (TTB) in regulating alcoholic beverages in the U.S. All establishments that produce alcoholic beverages for U.S. distribution must register with FDA, but the government agency that regulates the product’s labeling depends on certain criteria. Understanding these criteria can help manufacturers stay compliant with the regulations enforced for their particular products.

Get assistance with meeting FDA’s requirements for Alcoholic Beverages

Registrar Corp’s Regulatory Specialists can help you determine which FDA requirements apply to your alcoholic beverages. We can also help you register your product with FDA, review your labels for compliance, or assist with your product’s TTB labeling.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

Get Assistance

How are alcohol products regulated in the U.S.? Keep reading to learn about registration and labeling requirements.

Registration

Facilities that manufacture, process, pack, or store beer, wine, and spirits that may be consumed in the United States must register their facilities with FDA. Alcoholic beverages are subject to the Federal Food, Drug, and Cosmetic (FD&C) Act’s adulteration and misbranding provisions, and regulations related to food such as food facility registration, facility inspections, and good manufacturing practices.

Non-U.S. facilities distributing alcoholic beverages must also designate a U.S. agent during registration. The responsibilities of the U.S. Agent include:

  • Assisting FDA in communications with the foreign establishment
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States
  • Assisting FDA in scheduling inspections of the foreign establishment
  • Accepting information or documents from FDA if the Agency is unable to contact the foreign establishment directly or expeditiously. Such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Alcoholic Beverages Labeling Compliance

TTB regulates the labeling of distilled spirits, wines (7-24% alcohol by volume), and malted beverages as part of the Federal Alcohol Administration (FAA) Act. These products are also subject to the label approval process mandated by TTB. TTB regulates beers considered to be malted beverages, but some beers are not classified as such. If a beer is not made from malted barley, but rather a substitute such as sorghum, rice, or wheat, or if it is made without hops, TTB does not classify it as a malted beverage. FDA regulates the labeling of beers that are not considered malted beverages. Wines that fall below the 7 percent threshold established in the FAA definition for “wine” will also be subject to the labeling regulations promulgated by FDA.

If an alcoholic beverage does not fall under the FAA Act, the product is subject to FDA’s requirements under the FD&C Act, and the Fair Packaging and Labeling Act (FPLA). There are no pre-market label approval requirements for these products. However, the labels must comply with the FD&C and FPLA’s requirements, including:

  • A statement of identity
  • The net quantity of contents
  • The name and place of business of the manufacturer, packer, or distributor
  • A correctly formatted Nutrition Facts label
  • A list of the ingredients contained in the beer, ordered by weight
  • A list of all major food allergens contained in the beer

Although regulated by FDA, beers not considered malted beverages are also subject to some TTB labeling requirements, including the Government Health Warning Statement.

Get assistance with meeting FDA’s requirements for Alcoholic Beverages

Registrar Corp’s Regulatory Specialists can help you determine which FDA requirements apply to your alcoholic beverages. We can also help you register your product with FDA, review your labels for compliance, or assist with your product’s TTB labeling.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

Get Assistance

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Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

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