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                CFSAN Constituent Updates

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          FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBDCFSAN Constituent Updates FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD
  
  	
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November 21, 2022

Today, the U.S. Food and Drug Administration (FDA) posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).

Warning letters were sent to the following companies:

11-11-11 Brands
	Naturally Infused LLC
	Newhere Inc dba CBDFX
	Infusionz LLC
	CBD American Shaman, LLCThese companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.

The use of CBD raises safety concerns, especially with long-term use. Scientific studies show possible harm to the male reproductive system, including testicular atrophy, harm to the liver, and interactions with certain medications. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.

FDA experts commented on the agency’s concerns with adding CBD to food and on information they want consumers to know. View the conversation on our website.

Today’s warning letters also outline additional violations of the FD&C Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

**For More Information:**

Warning Letters
	What FDA is Doing to Protect Consumers from Cannabidiol (CBD) in Foods
	FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products
	FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
	FDA is Committed to Sound, Science-based Policy on CBD

                                                                                  Content current as of:
      11/21/2022
              
              
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