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Dear JT Taylor,. This letter is to advise you that the U. Examples of claims observed on your website apexhempoil. There is no animal food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction i. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before , through experience based on common use in animal food see 21 CFR We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. CBD is not approved for use in any animal food. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-named products. Based on available evidence, FDA has concluded that the prohibition in section ll applies to CBD, as described above. Food additives require premarket approval based on data demonstrating safety. There is no food additive regulation which authorizes the use of CBD. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before , through experience based on common use in food see 21 CFR We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Under section , a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any conventional food. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Nelson fda. Director of Compliance. Center for Veterinary Medicine. Food and Drug Administration. Donald D. Office of Compliance. Center for Drug Evaluation and Research. William A. Correll Jr. Center for Food Safety and Applied Nutrition. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. FDA considers a substance to be authorized for investigation as a new drug if it is the subject of an Investigational New Drug application IND that has gone into effect. Under 21 CFR About Warning and Close-Out Letters. Tobacco Retailer Warning Letters. Recipient Recipient Name. Recipient Title.
Oral Spray. For any Cannabis enthusiast, they should know of the current CBD craze that has seen companies such as Apex Hemp Oil take full advantage of the changes. Unfortunately, Apex Hemp Oil is not the only brand on the market since there is a lot of competition within the CBD products.
