Editorials

Hemp Companies Scolded By FDA for Medical Claims

In February 2015, the FDA issued warning letters to several hemp companies for making medical claims. The companies have 15 working days to comply or they could face enforcement consequences, according to FDA rules.

While hemp can be used as a nutritious dietary supplement, and has a multitude of uses, it will not stop a seizure or cure cancer. The problem is that some “medical hemp” companies have claimed otherwise and many sick, desperate people have been preyed upon.

Companies advertising hemp oil that is “legal in all 50 states” are actually selling industrial hemp waste, which contain very little cannabinoids. Industrial hemp typically contains far less CBD than cannabis. But still, because of a gray area in the law, industrial hemp is being imported and sold as medicine.

The conflict with the FDA stems from hemp being used for something other than industrial purposes. Medical claims put a product in the category of a drug, and no one can sell drugs without the FDA’s approval. Doing so is a violation of the law. According to the FDA’s website, “The agency position is that Warning Letters are issued only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act).”

FDA spokesman Jeff Ventura said, “The FDA has grown concerned at the proliferation of therapeutic claims being made about an increasing number of products, for sale in all 50 states, purporting to contain cannabidiol (CBD). The marketing and promotional materials for many of these products indicate they are intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of diseases, including, for example: cancer, various infections, psychiatric disorders, multiple sclerosis, arthritis and diabetes.”

Even though the FDA tested several products and found no cannabinoids at all, Ventura says, “The reason they got warning letters is not what is or isn’t in the product. It’s because they made therapeutic claims.” The FDA seems to be ignoring the issue of legality. For now.

Here is a list of the companies who received FDA warning letters and why:

Canna-Pet, LLC

Seattle-based Canna-Pet, LLC makes CBD-infused pet treats and supplements and received warning. Canna-Pet has a long list of medical claims found on the the company website. One was the recommendation that their cannabis products be used as “a daily food additive for all pets, but especially for those with arthritis, allergies, anxiety or behavior issues, compromised immune systems, diabetes, digestive issues, nausea, chronic pain, cancer, seizures, and those receiving palliative care.”

According to the FDA, Canna-Pet was claiming “medical benefits, behavioral benefits, prolonged life, reduced stress, and improved quality of life.” Canna-Pet’s website also listed the following as their product’s health benefits: “Antitumor, Antiepileptic, Anticancer, Anti-inflammatory, Bone stimulant, Analgesic, Anti-depressant, Antibacterial, Antipsoriatic, Antidiabetic, Anti-nausea, Anti-anxiety, Antipsychotic, Immunosuppressive.”

Strangely, while one product, Canna-Pet MaxCBD Capsules for Dogs, contained 2.6% CBD, 0.1% THC, and 0.1% CBC, and could legitimately be called medicine, Canna-Pet’s CBD Wedges – Canna-biscuits for Dogs, had NO cannabinoids present at all.

Canna Companion, LLC

Washington-based Canna Companion, LLC received a warning. The FDA cited medical claims by the company that the product could “Reduce cancer-associated symptoms, Aid in decreasing severity of dementia” and “Reduce bronchial spasms in asthmatics” in pets. The following list were qualities attributed to CBD: Antibacterial, Inhibits cancer cell growth, Reduces blood sugar levels, Reduces inflammation, Reduces risk of artery blockage, Slows bacterial growth, Treats psoriasis” among others.
Since receiving their letter, Canna Companion claims to be working on compliance. In an email to Hybrid, Sarah Brandon, DVM, of Canna Companion stated, “We are working closely with the FDA & have joined the NASC (National Animal Supplement Center) in order to take appropriate corrective action (regarding the letters).”

They also released a statement which said, in part, “in order to comply with FDA regulations, we are working closely with FDA representatives and NASC, the National Animal Supplement Council, correcting verbiage to the required “structure/function claims” in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act.  As such, we are limited in our phrasing of claims of potential health benefits to animals taking our product.  Terms like ‘arthritis’ may not be used but we can report our product ‘aids in joint discomfort caused by normal daily exercise.”

CBD Life Holdings, LLC

The FDA tested two separate samples of “UltraCBD,” ($45 for one ounce bottle). Of the samples tested, one did not contain any cannabinoids, and the second contained only .02% CBD. Ultra CBD advertised their products as treatments for arthritis, sleep problems, anxiety, malignant tumors, reduction of artery blockage, and even Ebola. The website published articles that, according to the FDA, serve as medical claims and proof of “the product’s intended use as a drug,” which violates the Federal Food, Drug, and Cosmetic Act.

Of all products that contained CBD and were tested by the FDA, the “UltraCBD” products contained the smallest amount. Spokesman Mo Asnani told USA Today that CBD Life Holdings is stepping up its third party testing to ensure product quality. He claimed to have test results that differ from the FDA but declined to elaborate.

As of March 14, 2015 the company website has a new legal disclaimer. The medical claims have been changed to describe UltraCBD Hemp Oil as dietary supplement.

Hemp Oil Care

California-based Hemp Oil Care sells cannabis-infused “products for therapeutic healthcare purposes.”

The FDA tested seven products and of the products tested, three products — Hemp Pure Vape E-Drops: Peached, ‘Hemp Honey 21% Cannabidiol Oil’, and Hemp Honey CBD Vape Oil – Blueberries & Cream, all tested negative for cannabinoids.  Three flavors of Cibdex Hemp CBD Complex Drops (peppermint, unflavored and vanilla) all contained .3% CBD.  The final product tested, Cibaderm Hemp Salve contained no CBD contained .2% cannabidiolic acid (CBDA). The products also lacked adequate directions for use.

The Hemp Oil Care website also published articles that, according to the FDA, serve as medical claims and proof of “the product’s intended use as a drug,” which violates the Federal Food, Drug, and Cosmetic Act. Each of these products had a list of medical claims. The Vape E-Drops alone claimed to have the following benefits: antipsychotic, vasorelaxant (lower blood pressure), antispasmodic, anti-cancer agent, anti-schemic, anti-bacterial and anti-diabetic.

PureCBD.net (Natural Organic Solutions)

PureCBD.net run by Natural Organic Solutions has taken its website down. Their medical claims included: treating the most aggressive forms of cancer, MS and resistant bacteria. They also claim that CBD is an anti-inflammatory. antipsychotic agent, and a possible treatment of schizophrenia.

The FDA tested four products offered by Natural Organic Solutions and sold online. Two of those products, “CBD Oil Extract Capsules (500mg – 10 Capsules)” and “21% CBD Hemp Oil Treatment” tested negative for cannabinoids. Repeated attempts to contact the owner have gone unanswered.

Twin Falls Bio Tech

Twin Falls Bio Tech was also warned and, according to the FDA, could not even spell cannabidiol or Crohn’s disease correctly. They sell a product called ArisiTol, ($99.95 for a one month supply) which they claim will help cancer, multiple sclerosis, diabetes, arthritis, dystonia, Crohn’s disease, as well as Rheumatoid and Severe Arthritis. Twin Falls had posted customer testimonials about ArisiTol to their website, in violation with FDA regulations.

Cancerherbtea

Florida-based Cancerherbtea sells a drink called Anamu. The Cancerherbtea website contains over-the-top claims of cures for breast, lung, prostrate, and colon cancers. Although they have received a warning letter,  the website is up and running as of the writing of this article. Phone calls to the company have not been returned and no record of testing on this product can be found.

Summary

The general response to these letters from the recipients range from attempts to comply to complete silence.

Ben Rollin, of Medical Hemp Industries said, “I am very glad that the FDA has performed as they have. These sites should not be claiming the cannabis products heal/cure/prevent/mitigate any disease or illness, since there are many more variables to consider that are simply not able to be taken into consideration. What was not disclosed by the FDA was their testing procedures and their facility, at least to this point. I am curious to see if that information is truly released.”

Richard Rose, founder of the Medical Hemp Association, and a vocal proponent of industrial hemp questions the FDA’s testing and results wrote in a public statement “I’m reluctant to jump on the potency issue raised by the recent letters from FDA, in the absence of supporting data. It might not be accurate, and FDA has an axe to grind.”

Rose said that making medical claims were “rookie mistakes” and referenced the FDA letters, “It’s something FDA does every few months, trot out some company mis-stating potency on their label. They’ve done it for decades, it is not confined to CBD companies.”

Rose is correct on one thing and that is that the FDA does regularly send out warning letters.  What isn’t “rookie mistake” or “a regular thing” is making false medical claims on such a grand scale. In 2013, the only warning letters sent out were to the makers of generic Tamiflu for internet marketing of an unapproved drug, In 2014, NOT ONE letter was sent out that was not related to failure to self-identify a facility and/or failure to pay the appropriate facility fee.

 

Click here for Warning letters and test results

http://down2earthholistichealth.com
About Sonja Renea (4 Articles)
Sonja Renea is a mother, a published writer, a gardener, artist and musician. She is also the author of the blog Cocaine Widow. She became involved in the Medical Marjiuana movement after her son was diagnosed with Crohn's disease and now serves as the Director of Communications for the Alabama Medical Marijuana Coalition. Sonja currently languishes in obscurity with her fiance, her son and her pets. She is currently working on a book.
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