Food and Drug Administration

The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD).  The Warning Letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims.  The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.

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On July 14th, the U.S. Food and Drug Administration (“FDA”) published a final rule amending the food facility registration requirement originally implemented under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  The final rule includes a number of changes that are designed to improve the accuracy of the food facility registration database.  It also amends the retail food establishments definition, expanding the number of establishments that are considered retail food establishments and, therefore, exempt from the registration requirement pursuant to 21 C.F.R. § 1.226.

Under Section 415 of the Federal Food, Drug, and Cosmetic Act, food facilities that manufacture, process, pack, or hold food for consumption in the United States are required to register with FDA. More specifically, a domestic registrant is now required to provide an e-mail address for the contact person at its facility and  a foreign facility registrant must provide the e-mail address for the U.S. agent for its facility.  Registration renewals must be completed every two years, and facilities must provide assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.

Additionally, the final rule adds a few new requirements intended to improve the food facility registration database:

  • as of July 14, 2016, registrations are required to contain the type of activity conducted at the facility for each food product category;
  • all food facility registrations are required to be submitted to the FDA electronically by January 4, 2020; and
  • food facilities will need to provide a unique facility identifier (“UFI”) as part of the registration process beginning October 1, 2020.

The amended regulations also permit registrants to submit a written waiver request explaining why it is not reasonable to submit the registration, registration renewal, updates, or cancellation to FDA electronically or to explain why it is not reasonable to provide the required e-mail address contact information. An abbreviated registration renewal process is now available for registrants who do not have any changes to the required information since submission of their proceeding registration or renewal.
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New regulations from the Food and Drug Administration (FDA) regarding nutritional information labeling are generating concern within the beer industry that the cost of compliance might be damaging and cost prohibitive for the industry.

Effective December 1, 2016, the FDA will require disclosure of nutritional information for regular menu items, including alcohol beverages, appearing on