What is a product recall?
A recall is a voluntary action taken by an industry member to remove an alcohol beverage from the marketplace. A recall may be initiated for various reasons including:
- Product quality
- Mislabeled product
- Contaminated or adulterated product
- Product found to be in violation of TTB regulations
- Product found to be in violation of the U.S. Food and Drug Administration's laws or regulations
The recalling industry member will:
- destroy the product;
- re-label it, if appropriate, with corrected, approved labels; or
- take other appropriate corrective action.
What is TTB's policy concerning alcohol beverage recalls?
TTB issued an industry circular to provide guidance and explain our policy on voluntary recalls. Please read Industry Circular 2017-4 - Voluntary Beverage Alcohol Recalls for more information.
How does TTB interact with other Federal agencies in handling alcohol beverage recalls?
We operate under a 1987 Memorandum of Understanding (MOU) with FDA. Under the terms of this MOU, we have primary responsibility for seeking and monitoring voluntary recalls of alcohol beverages.
When we learn that an alcohol beverage is or may be adulterated, we consult with FDA before requesting any recall action. If needed, FDA provides us with a written health hazard evaluation. If FDA's health hazard evaluation indicates a definitive hazard, we will advise the responsible industry members and request they take an appropriate course of action. If FDA concludes there is no adverse risk to health, we may still request a voluntary recall if the product is mislabeled due to the presence of unauthorized or adulterated substances.
Industry members should also be aware of the reporting obligations through FDA's "Reportable Food Registry." Additional information on these requirements can be found on FDA's website at www.fda.gov.
TTB will work appropriately with the FDA and other concerned Federal and State regulatory agencies. These agencies may include Alcohol Beverage Control Boards and Departments of Health, or equivalent organizations, in the States where the products subject to recall are distributed.
Who is responsible for initiating a voluntary recall?
A voluntary recall may be initiated by you or it may occur as a response to a request from us. A voluntary recall requested by us is normally limited to situations involving health hazards or cases involving significant mislabeling. We direct these requests to the industry members who have primary responsibility for the manufacturing, importation, distribution, or marketing of the product.
What procedures does TTB follow in the event of a recall?
For each TTB-recommended voluntary recall, we will contact the affected industry members in order to provide both a verbal and written notice of the requested action. For each industry member-initiated recall, the industry member should contact the Market Compliance Office at 202-453-2251 (option 3). We will ask you to devise and inform us of an appropriate recall strategy for removal of the product from the market.
Upon completion of the recall, we will ask you for a final report that may include:
- Background and Product Information (complete information on the industry member, permit number or brewer's notice, manufacturer, reason for recall, beverage safety and potential health issues identified, description of product, and affected sizes);
- Inspection and Analysis (volume of recalled product involved in the distribution chain including, foreign/wholesale/retail/industry member premises and warehouses, and how this information, including when product was destroyed, was communicated to you);
- Adverse Health Reports Received/Consumer Complaints;
- Recall Decision-Making Process;
- Recall Effectiveness (including notifications and to what parties, any Press Releases); and
- Corrective Action (corrective action taken and future safeguards).
- Tax Implications (information related to any tax claims submitted for destroyed product)
While this list is not comprehensive, nor is it mandatory that your report include each topic, we will request a complete report with adequate information to show that the issue has been resolved and that you have taken steps to ensure similar incidents will not occur in the future.