FDA steps up inspections of breweries—what’s next?

By Larry Reichman | Sep 01, 2015

As a brewery owner, you are already familiar with the requirements of the Tobacco, Tax and Trade Bureau (TTB) and your state's liquor control commission. But did you know that the Food and Drug Administration (FDA) also regulates your operations and will be coming to inspect sometime soon?

The FDA has jurisdiction over many aspects of your business, including both the inputs to and the outputs of your operation. For example:

· Registration. Breweries are required to register with the FDA and to renew their registration every two years.

· Good manufacturing practices. Beer-making includes several activities that are considered the processing and manufacturing of food, which the FDA regulates. Holding grains and other food products for processing and beer for shipment is also subject to regulation. This means that your operations need to be sanitary and that you have analyzed them to address any potential hazards and implemented good manufacturing practices to minimize such hazards.

· Labeling requirements. Beers that contain both malted barley and hops are subject to TTB labeling regulations. Types of beer that do not contain both malted barley and hops (for example, those made with rice or wheat, in lieu of malt) are subject to FDA labeling requirements such as: disclosure of ingredients including spices, flavorings, colorings, chemical preservatives; disclosure of certain allergens, such as wheat, and even nutrition facts, unless exempt.

· Recordkeeping and reporting. Breweries must make and keep records of the immediate sources of food and the immediate recipients of products they sell. In the event of the release of adulterated food from a production, bottling or manufacturing facility, FDA may require the release be reported.

· Food service and gift shops. Not only is beer food, but food is food! Do you serve or sell unpackaged food in your tasting room or pub? Do you sell packaged food products in addition to beer, such as olive oils, cheese, food baskets, crackers, or honey? Food products that you serve or sell on premise may be subject to federal, as well as state or local, regulations. There are exemptions that may apply, but you should be informed.

· Bulk sales. Bulk sales of foods and processing byproducts are still subject to FDA regulation. In 2014, after great uproar from the brewing industry, the FDA backed down from more stringently regulating brewers marketing their brewers' grain to local animal producers. But the sale of byproducts, such as spent grain for animal feed, is still subject to some FDA regulation (animal food is food too!).

· Inspections. FDA is obligated to inspect every brewery in this country over the next several years. This means that they can observe your manufacturing processes and carefully inspect your facility and all aspects of your operation. They may also ask to review your records and photograph your operations. You should be prepared for any kind of surprise inspection.

With the increased emphasis on food safety, and the increasing regulations, it pays to be well informed and prepared.

Larry Reichman is an attorney with Perkins Coie, LLP. Reach him at lreichman@perkinscoie.com.