In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.
15. Can I import or export cannabis-containing or cannabis-derived products?
The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
Children and Pregnant/Lactating Women
While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.
FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.
A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:
These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.
Several examples of such labeling or marketing were included in the letters, many of which clearly appeared to violate the cited regulations:
The FDA just outlawed CBDs and hemp oil extracts by invoking a totally insane regulation you won’t even believe. Because a drug company is investigating CBDs for use as a medication, the FDA now says it is illegal for CBDs to be sold in any dietary supplement.
The next link pointed to a nearly month-old article published by the Cannabusiness web site on 22 February 2016. Cannabusiness‘ coverage appeared to describe CBDs labeled and marketed in a manner that violated FDA labeling regulations:
The term “drug” means … (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals[.]
Cannabusiness linked to a 16 February 2016 article published by legal blog Above The Law, which concisely explained why the FDA was sending letters to CBD oil vendors:
In summation, the FDA’s warning involved how the products were marketed and labeled (as drugs intended to cure, prevent, or treat a medical condition), and not the legality of the products themselves. At some point between 20 March 2016 and 23 March 2016, Natural News significantly edited the original article, with Adams disingenuously maintaining that his use of the rather unambiguous term “outlawed” had been misconstrued by readers to mean that the products in question had been “outlawed”:
This continues the FDA’s ongoing battle against unapproved CBD products. In April of 2015, the FDA issued six similar warnings to companies with varying amounts of CBD. Pain Bomb, one of the companies in question, was issued an FDA warning February 4th, 2016. Members of the FDA wrote “PainBomb violated the FDC [Food, Drug, and Cosmetic] Act by misbranding its products. The diseases for which PainBomb marketed its products cannot be self-diagnosed or self-treated by people other than health care professionals. For this reason, PainBomb’s instruction labels informing users whether and how to use its products violate the FDC Act.” The Federal Food, Drug and Cosmetic Act, otherwise known as the FDC Act, requires scientific information to demonstrate that a drug is safe. Pain Bomb allegedly violated section 201(g)(1)(B) of the FDC Act [21 U.S.C. § 321(g)(1)(B)]. The FDA gave Pain Bomb only 15 business days to correct all foregoing violations.
It is an awesome place to stay, very good location away from the crowds. Great views, newly constructed resort. Staff is really very helpful and prompt. Food is one of the best I ever had. Give it a try, you will not regret it Navdeep Singh
One of the best stays in Manali….Was there for 4 nights Nagra Honey
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We have had a really wonderful stay at Anantmaya, Manali. Beautiful property with not just a view but with some great views. It has that personal touch service that can not be beaten. Food – Superb. Comfort – It has lots of that. Highly recommended. Thanks so much for a very enjoyable holiday! Anil Advani
One of the best places we have stayed at so far. Amazing resort, amazing hospitality and amazing location Devika Chatterjee Ahluwalia
Awesome resort & Services. one of my best stays Suman Malik