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TTB NEWSLETTER | Weekly News

July 31, 2015


IN THIS ISSUE

Greetings! We hope you had a gorgeous and satisfying week! This week's top stories include three items that show both TTB and FDA have jurisdiction over U.S. alcohol beverage businesses, and a list of the past week's top Labeling Resources pages at TTB.gov/.

QUESTIONS ABOUT FDA INSPECTIONS OF U.S. WINERIES, DISTILLED SPIRITS PLANTS, AND BREWERIES

We’ve received a number of inquiries recently from industry members about U.S. Food and Drug Administration (FDA) inspections of their premises. Put simply, the facilities of alcohol beverage producers are subject to FDA inspection authority over food manufacturing and processing facilities (see 21 U.S.C. 374).

TTB regulates alcohol beverages under the Federal Alcohol Administration Act and the Internal Revenue Code of 1986, as amended; FDA oversees the safety of food, drugs, and cosmetics under the authority of the U.S. Federal Food, Drug, and Cosmetic Act, which was amended by the Food Safety Modernization Act in 2011. FDA has authority over ingredient safety and adulteration issues pertaining to foods (including alcohol beverages) under the Federal Food, Drug, and Cosmetic Act.

It is our position that alcohol beverages found by FDA to be adulterated under the Federal Food, Drug, and Cosmetic Act are mislabeled under the Federal Alcohol Administration Act.

For further information about FDA activities, visit the FDA.gov/ Food page, or contact the FDA directly:

Outreach and Information Center

1-888-SAFEFOOD
1-888-723-3366

Inquiries: Submit Your Question

Center for Food Safety and Applied Nutrition

Food and Drug Administration

5100 Paint Branch Parkway
College Park, MD 20740

Industry and Consumer Assistance

FDA PROPOSES ADDITIONAL REVISIONS TO NUTRITION FACTS LABEL

Certain alcohol beverages are not subject to the labeling and advertising rules stemming from the Federal Alcohol Administration Act. Beer that does not contain malted barley or hops and wine (including cider and mead) that contains under 7% alcohol by volume are subject to the food labeling rules under the Federal Food, Drug and Cosmetic Act. If you manufacture such products, FDA’s proposed additional revisions to the nutrition facts label may be of interest to you.

Source:  FDA Constituent Update - July 24, 2015 (excerpt)

The FDA is proposing additional revisions to the Nutrition Facts label for packaged foods. The supplemental proposal would, among other things, require declaration of the percent daily value (%DV) for added sugars. The proposed rule is a supplement to the March 3, 2014 proposed rule on updating the Nutrition Facts label. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families.

The FDA is seeking public comment on the proposal for 75 days. The agency continues to review comments received on the 2014 proposed rule and is reopening the comment period on its March 2014 proposal for 60 days to invite public comment on two consumer studies related to label formats. The agency will consider comments on the original and this supplemental proposed rule before issuing a final rule.

For More Information

NEW FDA TOOLS WOULD ADVANCE EFFORTS TO ENSURE SAFETY OF IMPORTED FOODS

Source: FDA Constituent Update - July 23, 2015 (excerpt)

The FDA has published a proposed rule and a draft guidance document to support a new program under the FDA Food Safety Modernization Act (FSMA) that will help eligible foreign entities demonstrate that imported food meets U.S. food safety requirements. Audits and certifications for eligible foreign entities under this program will be used by importers applying for expedited review through the Voluntary Qualified Importer Program, and may also be required by FDA as a condition of granting imported food admission into the United States when certain food safety risks have been identified.

The proposed rule would establish user fees for participation in the program created by the Accreditation of Third-Party Auditors/Certification Bodies proposed rule scheduled to become final this fall. The Accreditation of Third-Party Auditors/Certification Bodies proposed rule, as its title indicates, would establish a program through which the FDA would recognize the entities that would accredit third-party auditors (also known as certification bodies) to conduct food safety audits and issue certifications.

The draft guidance is a set of model standards containing recommendations on the qualifications that third-party auditors/certification bodies, and their auditing agents, should have in such areas as education and experience.

For More Information

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