write the secondary responses for the following 3 primary responses.
1.Hello All,
The FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. The agency has, however, approved one cannabis-derived drug product: Epidiolex (cannabidiol), and three synthetic cannabis-related drug products: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone) but the FDA understands that there is increasing interest in the potential utility of cannabis for a variety of medical conditions, as well as research on the potential adverse health effects from the use of cannabis. FDA has approved Epidiolex, which contains a purified form of the drug substance cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.1
The FDA has an important role to play in supporting scientific research into the medical uses of cannabis and its constituents in scientifically valid investigations as part of the agencys drug review and approval process. 1 As a part of this role, the FDA supports those in the medical research community who intend to study cannabis by intended use, proper information with the specific requirements, Protocols to research with controlled substances listed in Schedule I under 21CFR1301.18. 1 For certain drugs that have not been approved by the FDA, the lack of FDA approval and oversight means the safety, effectiveness, and quality of the drug including how potent it is, how pure it is, and whether the labeling is accurate or false may vary considerably. 1
The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. he FDA has not approved any CBD products other than prescription to treat rare, severe forms of epilepsy. 2 There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body. 2 The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
2. The Cannabis regulation has always been like a rotten fish under the carpet, it only gets attention when it starts stinking. FDAs regulations regrading Cannabis is somewhat vague, at one point they clear Epidiolex and on the other hand, they are reluctant to put some serious seizures over its non-compliant manufacturing. Under FD&C Act, any product, including a cannabis product (hemp or otherwise), that is marketed with a claim of therapeutic benefit or with any other disease claim, is considered to be a drug. And a new drug required to approved first for its intended use by the FDA before it can introduce in the interstate commerce. FDA has touched the CBD and THC under section 301(ii), CBD and THC cannot be added to foods under the FD&C Act regardless of whether the substances are hemp derived.
To-date, FDA has approved some cannabis derived products on the basis of the complete research and approval process, FDA has been holding the same stance for the rest of the Cannabis, this is why those substances whose intended use is not established yet is still falling under the CS 1, and it cannot be traded legally. FDA did issue a quite number of warning letters to those manufactures who violate this practice.
In my view, FDA rather dwelling in the grey area about cannabis regulation, should come out crystal clear in its stance. With the current ambiguities only black market is getting all the profit, when everyone knows that in stocks market, the rate gets higher of those companies who sells these products illegally, what else can be seen. Its all there and it needs strict attention.
3. The guidance document “FDA and Cannabis: Research and Drug Approval Process” illustrates the FDAs ideas on the regulation of the cannabis derived products. The 2018 Farm Bill explicitly preserves FDAs authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products meaning theyre subject to the same authorities and requirements as FDA-regulated products containing any other substance.[1]
The cannabis-related and cannabis-derived compounds should require FDAs approval unlike any other product going through stringent regulations. Submission of an IND to the FDAs CDER could enable the companies to conduct clinical research which could lead to an approved new drug which is derived from cannabis or related to cannabis. FDA also encourages the sponsors to contact the CDER review and its Botanical Review Team to address any questions the sponsors might have regarding their products. The FDAs role in the regulation of drugs, including cannabis and cannabis-derived products, also includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications.[2]
The FDAs drug approval process requires that clinical trials be designed and conducted in a way that provides the agency with the necessary scientific data upon which the FDA can make its approval decisions. Without this review, the FDA cannot determine whether a drug product is safe and effective. It also cannot ensure that a drug product meets appropriate quality standards. For certain drugs that have not been approved by the FDA, the lack of FDA approval and oversight means the safety, effectiveness, and quality of the drug including how potent it is, how pure it is, and whether the labeling is accurate or false may vary considerably.[2]
All in all, the current set of regulations for the cannabis derived and related products put forth by the FDA are adequate.
