FDA, FTC Take Action on CBD-Infused Products Prior to Public Comments

Letters sent to three companies, warning of ‘unsubstantiated claims.’

FDA Gottlieb Teich Shutterstock mgretailer
FDA Gottlieb Teich Shutterstock mgretailer

WASHINGTON, D.C.–Action by the Food and Drug Administration (FDA) on the regulation of CBD-infused products seems imminent, after recent events may signal new developments at the agency.

The FDA joined the Federal Trade Commission (FTC) this week to issue letters to three CBD companies, warning them to cease “unsubstantiated advertising claims.” The brands that received warning letters included New Jersey-based Relievus (with pain clinics located in Philadelphia), as well as product manufacturers CBDPure and Diamond CBD.

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The Philadelphia Inquirer reported that Relievus President Young J. Lee had told them on Tuesday the company was working closely with the FDA “regarding the rules and regulations on CBD products.” Meantime, the company has stopped sales of CBD products, removed products from the company website, and said they would no longer advertise on social media, according to Philly.com.

The FDA is under increasing pressure from state lawmakers and Congress to address regulation around cannabis-derived products, including CBD-infused products, which have seen a boon across the health supplements market.

The FDA this week also outlined a public meeting that will be held on May 31st, where the agency said it would gather comments and more information from CBD industry stakeholders. Email and written comments will be accepted until July 2, 2019.

In a press release issued Tuesday FDA Commissioner Dr. Scott Gottlieb, M.D., also addressed the process that the agency will undertake toward developing potential standards and regulations for CBD products. According to the statement, key points included:

  • A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
  • The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
  • Updates to [the FDA] webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
  • The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.

The May 31 meeting is scheduled to take place at the FDA’s White Oak Campus, located in Silver Spring, Maryland.

For further information on the May 31 meeting and public comment period, contact Beth F. Fritsch, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 32, Rm. 5308, Silver Spring, MD 20993, 301-796-8451, [email protected].

Photo: Albert H. Teich/Shutterstock

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