Yesterday, 1st November 2017, the U.S. Food and Drug Administration, FDA, released a statement warning the general public against fraudulent claims regarding marijuana based cancer cures. The FDA has also issued warnings in writing to four companies that are selling such products online illegally. These products are being advertised as miracle cures for cancers and several serious conditions.
FDA warning on marijuana based cancer cures. Image Credit: ShutterstockProfessional / Shutterstock
The FDA in the statement says that selling these products which have no proven benefits and therapeutic use is a violation of the Federal Food, Drug and Cosmetic Act. This violation could put several lives at risk says the agency because these products have not been proven to be safe or effective. This deception leads to several patients with serious life-threatening ailments to access recognized treatment regimens in favour of these false claims.
The FDA particularly is cracking down upon products sold as cures for cancer but actually containing cannabidiol (CBD) that is obtained from cannabis or marijuana. FDA has not approved use of marijuana in any medicinal product for any disease. Cannabidiol from cannabis is sold in several dosage forms including capsules, syrups, skin lotions or creams, oil drops and teas. These four companies are selling and distributing products and making these false claims saying that cannabidiol containing products could prevent, reverse or even cure cancer by killing the cancer cells and reducing size of the tumors. Some of these are also being sold as cures for neurological diseases such as Alzheimer’s disease.
FDA Commissioner Scott Gottlieb, MD has said in his statement, “Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products.” He added that there are a growing number of effective treatments available for cancer management. Marketing these illegal agents “steer patients away from products that have proven, anti-tumor effects that could extend lives”, he explained.
The four companies to receive the warning letters from the FDA include Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting and Stanley Brothers Social Enterprises LLC. These companies are selling over 25 products over several online stores and websites says the FDA statement. These pages contain the unsubstantiated bogus claims about these drugs. The FDA cites some of the claims such as “makes cancer cells commit ‘suicide’ without killing other cells”, “combats tumor and cancer cells”, “inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow”, “effective in treating tumors from cancer – including breast cancer” etc.
The FDA explains to the general public that unlike most of the other medicinal products that are FDA approved, these products have not gone through the process of FDA review and approval that is a rigorous analysis and evaluation of the drug’s process of development through controlled clinical trials. The mechanism of how these might work or their appropriate dosing also has not been studied in depth and approved by the FDA. Some of these could have dangerous side effects warns the statement and some of these could interact dangerously with other food items and medications consumed. These issues are usually studied in details for the FDA approved drugs before they are available for the general public for use. These spurious products have not undergone any of these regulatory processes that make them safe for use.
As of now the agency has asked the four companies to address the violations and answer to the queries regarding how these violations would be corrected. If these violations are not corrected, legal action would be taken against these companies that include “seizure and injunction” says the statement.
Commissioner Gottlieb said, “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.” Over 90 similar warning letters have been sent out in the past decade that statement said of which over a dozen were in this year itself. These aim to stop the fraudulent claims that could misguide and jeopardize the safety of the general public the agency said. Stem cell centres that make such fraudulent claims too are under the FDA scanner. Health care professionals and consumers are called upon to report side effects and problems faced with the use of these fraudulent treatments and medicinal products to the MedWatch program.
Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583295.htm
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