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fda outlaws cbd and hemp oil

A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. 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 FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

A. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

FDA Communications

14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?

There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.

A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.

Warning letters dated 4 February 2016 were published by the FDA to their web site, and the manner in which the agency alleged the CBD manufacturers were in violation of the FDC Act (i.e., marketing their products as dietary supplements) was clearly described:

In April 2015, the FDA sent warning letters to six companies whose products allegedly contained CBD. The FDA warned these companies about marketing and selling unapproved drugs to diagnose, mitigate, treat, or prevent diseases in humans or animals. The FDA sent out a fresh round of warning letters to eight new companies. The FDA’s February 4th letter to PainBomb, LLC about the company’s “PainBomb+CBD” products is representative of the letters, and it states … PainBomb’s websites and accompanying literature seek to sell drugs covered by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act [(the “FDC Act”)] [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. PainBomb violated the FDC 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.

Claim

Hemp oil extracts containing CBDs (cannibidiols) are such a threat to the pharmaceutical industry that the FDA is now invoking totally insane justifications for outlawing them. CBDs are non-psychoactive compounds found naturally in hemp plants. They work so well as powerful natural medicine that people everywhere are realizing CBDs work better than pharmaceuticals for treating epilepsy, seizures, neurological disorders and other serious health conditions (including HIV infections). So the FDA has just launched a massive regulatory assault against CBDs by invoking the most insane logic you’ve ever heard … The FDA just criminalized one of the most miraculous healing medicines in the world by handing it over to Big Pharma[.] In other words, the FDA just handed Big Pharma an absolute monopoly over CBDs (hemp oil extract) by ridiculously claiming such natural products are “adulterated” with molecules (CBDs) that the FDA says might one day become a drug.

Despite lengthy edits, the article remained factually inaccurate, claiming that the FDA asserted CBD oils were “adulterated products”:

Now the FDA has begun sending warning letters to CBD makers, claiming they are in violation of FDA regulations because they are selling “adulterated products.” Adulterated with what, exactly? CBDs, of course! “The debate over hemp CBD’s legal status continues after FDA sent eight warning letters to manufacturers of CBD dietary supplement and food products earlier this month,” reports Nutritional Outlook. “The warning letters cite impermissible health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration.”

The pending legislation would also give authority to the Ohio Department of Agriculture to regulate hemp instead of the Ohio Department of Pharmacy as it currently stands. [iv] In Ohio, CBD oil and other hemp products can only be dispensed in a licensed Medical Marijuana Control Program dispensary at the present time. Growing, processing, or selling hemp or CBD oil in Ohio without the proper license is illegal. If the legislation passes the in the House, Ohio could be on its way to legal sales of CBD oil and hemp products. Hemp can be used in industrial applications such as paper, textiles, and biofuel. CBD oil is claimed to be a useful supplement as well.

These actions items are a significant step for the future of hemp and CBD oil sales and marketing nationally. Even so, hemp is still considered a Schedule II controlled substance in Ohio. [ii] Recently, however, the Ohio Senate voted unanimously to legalize hemp and related products, including CBD oil. The bill moves on to the Ohio House of Representatives. [iii]

Related Legal Headlines

One of the more popular and prevalent hemp products is cannabidiol, also known as CBD oil. The FDA’s recently announced framework could provide a pathway for marketing CBD oil. The FDA’s announced framework includes:

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