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KoiCBD takes safety and accuracy very seriously and has multiple protocols in place to ensure a safe and accurate potency of its CBD products. All of their products are tested multiple times to ensure quality, potency, and safety. The company has invested in state-of-the-art laboratory equipment and employs a team of scientists and technicians who specialize in quality control and testing. KoiCBD also ensures that all of its products are third-party tested and verified by the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA). Additionally, the company has a strict manufacturing process that follows Good Manufacturing Practices (GMP) guidelines.
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This letter is to advise you that the U. 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 mentioned products. See 21 CFR The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. 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. Food containing an unsafe food additive within the meaning of section is adulterated within the meaning of section a 2 C i. Based on available evidence, FDA has concluded that the prohibition in section ll applies to CBD, as described above. 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. 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. Your response should be sent to U. Correll Jr. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. Under 21 CFR About Warning and Close-Out Letters. Tobacco Retailer Warning Letters.