The Food and Drug Administration (FDA) is the federal agency responsible for regulating drugs and food products in the United States. Currently, there are no FDA-approved medications that contain cannabidiol (CBD). The FDA has concluded that the prohibition in section 301 (ll) of the Federal Food, Drug and Cosmetic Act (FD&C Act) applies to CBD. This means that it is illegal to introduce or deliver for introduction into interstate commerce any animal feed to which CBD has been added.
The FDA has not evaluated CBD products to determine the appropriate dose, how they could interact with other drugs or foods, or if they have dangerous side effects or other safety problems. The agency is working to answer these questions through ongoing efforts, including comments from a recent FDA hearing and collecting information and data through a public registry. The FDA recommends that pet owners talk to their vets about appropriate treatment options for their pets. The agency also considers that the investigation of a substance as a new drug is authorized if it is the subject of an application for a new investigational drug (IND) that has become effective.
For years, Congress has been pushing to change laws to give the FDA broader jurisdiction over cosmetics. As part of these actions, the FDA has analyzed the chemical content of cannabinoid compounds in some of the products and it was discovered that many did not contain the levels of CBD they claimed to contain. The agency has determined that its Apex CBD Livestock Pellets, Apex Organic K9 Oil and Apex CBD Dog Treats products are new unapproved animal drugs that are not safe under section 512 (a) of the FD&C Act. The FDA regulations at 21 CFR 170.30 (a) - (c) describe the eligibility criteria for the classification of a food ingredient as Generally Recognized as Safe (GRAS). However, based on available evidence, the FDA has concluded that this is not the case with CBD. Therefore, hemp lotion is not currently approved by the FDA. New drugs cannot be legally introduced or delivered for introduction into interstate commerce without prior approval by the FDA, as described in sections 301 (d) and 505 (a) of Act FD&C, 21 U.
S. C. The FDA approves a new drug based on scientific data and information showing that the drug is safe and effective. Failure to promptly correct violations may result in unannounced legal action, including, but not limited to, seizure and court order. It is your responsibility to ensure that your company complies with all the requirements of federal law, including FDA regulations.
You must take swift action to correct any violations cited by the FDA. The FDA is working to answer questions about the science, safety and quality of products containing cannabis and compounds derived from cannabis, in particular CBD. In addition, it is important for consumers to be aware of potential risks associated with CBD products before using them.
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