FDA Sends Warning Letters to CBD Oil Companies

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Washington, D.C. — On October 31, the U.S. Food and Drug Administration (FDA) sent a warning letter to four companies which sell hemp oils marketed as having cannabidiol (CBD), a non-psychoactive cannabinoid found in hemp that is considered to have a variety of health benefits. Unfortunately, these benefits are not recognized by FDA and according to a press release by the Agency, the firms received warning letters because they “distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.”

These four companies include Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC (maker of CW Hemp). FDA alleges that claims made on the websites and social media platforms of these companies establish their products as “drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body.”

It is well known that dietary supplements are not allowed to make disease claims and while most of these companies don’t directly state disease claims, FDA includes testimonials, links to other web pages that provide dosage instructions for those with diseases as well as quoting, citing or linking to clinical research that demonstrate benefits of CBD for particular disease states as claims. For that matter, FDA does not recognize CBD as a dietary supplement either, because while all these companies market their products as dietary supplements, “FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if an article (such as CBD) 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 outside the definition of a dietary supplement.”

Because firms like GW Pharmaceuticals are investigating CBD as a potential new drug, FDA is excluding all CBD products from the dietary supplement category. The Agency also contends that CBD was never marketed as a dietary supplement or food prior to DSHEA (although that is debatable). The companies were given 15 days to notify FDA of the steps taken to correct the violations.

That’s Natural has responded to FDA and taken action, “taking down the requested links to peer-reviewed journal articles on our site and social media. We have deleted our Facebook Page, our Twitter Page, and have taken down our Customer Testimonials as well as the other cited articles from the Warning Letter,” according to a press release. However, the CEO Tisha T. Casida did take the opportunity to address the warning letter (with the disclaimer that her opinions are her own and not that of the company). Casida takes issue with FDA preventing the manufacture and use of naturally-occurring cannabinoids (such as CBD) because of the investigation of synthesized  CBD by drug companies as well as the hypocrisy of the Department of Health and Human Services holding a patent on cannabinoids (Patent #6,630,507) which states, among other things, “Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases.”

She also defends her use of citing studies on the company’s website. “Over the past 40 years, there have been over 20,000 journal articles on cannabinoids and their potential positive effects for disease — you can find many of these on the government website — the National Institutes of Health (NIH),” Casida writes. “These are peer-reviewed journal articles from researchers with the knowledge of what cannabinoids can do for people’s Endocannabinoid System — the applications are immense.  As a company, we think it is our first amendment right to publish links to government-supported media (NIH) where peer-reviewed journal articles exist.”

In a strange twist, the letter addressed to Ms. Laura Fuentes, Greenroads Health, Green Roads of Florida LLC appears to be a case of mistaken identity. Green Roads of Florida, LLC. which includes GreenRoadsWorld.com and GreenRoadsWellness.com is not affiliated with Greenroads Health. FDA’s confusion between the two companies was likely caused by Greenroads Health’s unauthorized use of the “Green Roads” name, logo and website imagery. Green Roads of Florida is actively addressing this issue to prevent companies such as Greenroads Health from emulating their brand so closely that it is confusing to consumers.

“We sincerely apologize for any confusion this has caused to our loyal customers, and we are working diligently to ensure that our products and product information is immediately removed from this independent distributor’s website,” said Laura Fuentes, CEO of Green Roads of Florida, LLC in an official statement. “At Green Roads, we produce only the finest quality products, using the best ingredients, and we appreciate the continued outpouring of support and testimonials we have received from people who have reportedly benefited from our products.”

Green Roads of Florida’s PR representative, James Judge, told WholeFoods that Greenroads of Florida “Would be more than thrilled to have regulation in this industry.” Because the industry is unregulated, he says, there are many unreliable products on the market. “We want people taking CBD to be getting the best quality product that they can. We are big believers in the industry needing some regulation for safety reasons.” Judge continued.  He stated that the company stands behind the FDA’s enforcement.

All Green Roads products are manufactured in a pharmacy-grade setting from 100-percent-certified industrial hemp, not marijuana, and are in full compliance with the U.S. Farm Bill. Green Roads products contain zero THC, making them legal in all 50 states. “We operate under strict, self-imposed conditions,” said Judge. “We send the product out for testing before and after production to make sure what it says on the label is what you get. Our potency is guaranteed.”

CW Hemp has yet to respond to a request for comment from WholeFoods Magazine.

1 COMMENT

  1. “FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if an article (such as CBD) 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 outside the definition of a dietary supplement.”

    CBD Oil from Hemp technically did not become legal till the 2014 farm bill and still the DEA is saber rattling saying it is illegal. All this while the FDA hands a MONOPOLY to the pharmaceutical industry? My first thought is that the FDA actions must be illegal. My second thought is that is illegal. If CBD Oil from Hemp is not allowed to be distributed as a dietary supplement then the “public will be failed” and that is in clear violation of Antitrust laws which predates and law that gives FDA any jurisdiction. Also no federal funds may be used to “to prohibit the transportation, processing, sale or use of industrial hemp that is grown or cultivated in accordance with [the Farm Bill]”.

    The FDA need not obstruct our right to have health and wellness and they need not obstruct us from having full access to dietary supplements that are safe and effective to help us maintain our health and wellness.

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