FDA Issues Warnings to Makers of ‘Legal’ CBD Hemp Oil Products

WASHINGTON, DC — The Food and Drug Administration (FDA) has sent letters to several makers of cannabidiol (CBD) oils derived from hemp, telling them to stop making medical claims about their products’ ability to treat disease.

Many sellers of hemp-based cannabidiol products, who advertise their products as “legal in all 50 states” because they are derived from industrial hemp, have been making claims that their products are rich in cannabidiol (CBD) and can be used for “the diagnosis, cure, mitigation, treatment, or prevention of diseases,” according to the FDA.

The FDA, which considers CBD an “unapproved new drug,” says these companies are mis-branding the products and issuing false claims to consumers.  Often these products do not even list their ingredients on the product label, the FDA added.

“Consumers should beware purchasing and using any such products,” the FDA says.  “It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease.”

In late February, the FDA issued several warning letters to seven companies that manufacture and market hemp oils claiming to be “rich in CBD.”  By promising cures for conditions such as cancer, autism and epilepsy — none of which have been tested by the FDA — the companies who were issued warning letters appear to be violating food and drug labeling laws.

In some cases, the companies could not even spell “cannabidiol” or “inflammation” correctly, the FDA notes.\

The following companies and products were among those notified by the FDA (with hyperlinks opening each company’s letter in a new window):   Cancerherbtea.com of Florida; CBD Life Holdings, LLC (makers of Ultra CBD) of Arizona; Hemp Oil Care of California; PureCBD.net of Washington; Twin Falls Bio Tech of South Carolina; Canna Companion of Washington; and Canna Pet of Washington.

The FDA also conducted tests of some products sold by these companies, and found found that in most cases, the products contained very little cannabidiol — or none at all:

  • The FDA tested two separate samples of “UltraCBD,” sold by CBD Life Holdings LLC (a one ounce bottle costs $45 on their website or Amazon).  Of the samples tested, one did not contain any cannabinoids — CBD or otherwise — while the second contained only .02% CBD.  Of all products tested by the FDA that were found to contain some CBD, the “UltraCBD” products contained the smallest percentage.
  • The FDA tested seven products sold by California-based Hemp Oil Care.  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 but did contain .2% cannabidiolic acid (CBDA).
  • The FDA tested four products offered by Natural Organic Solutions and sold at purecbd.net.  Two of those products, “CBD Oil Extract Capsules (500mg – 10 Capsules)” and “21% CBD Hemp Oil Treatment” tested negative for cannabinoids.  Of the remaining two products tested, “Real CBD Extract – CBD (Cannabidiol) Cannabis Extract Capsules (1500mg – 30 Capsules)” contained .5% CBD, .2% THC (tetrahydrocannabinol), .1% CBDA, .03% THCA (tetrahydrocannabinol acid); while their “26% CBD Hemp Oil Treatment” was found to contain .14% CBD, .45% THC, and .05% CBDA.
  • The FDA tested Arisi-Tol, made by Twin Falls Bio Tech LLC, and found that their product, which sells for $99.95 for a one month supply, contained .2% CBD.
  • The FDA also tested two manufacturers of CBD products marketed for pets.  From Washington-based Canna Companion LLC, the FDA tested “Canna Companion Capsule Size: 4” and found that the product contained .1% CBD, .1% THC, .3% CBDA and .9% THCA.   Three products from Canna-Pet LLC were also tested, with “CBD Wedges – Canna-Biscuits for Dogs” testing negative for cannabinoids, “Canna-Pet for Cats” containing .5% CBD, and “Canna-Pet MaxCBD Capsules for Dogs” containing 2.6% CBD (the highest percentage of all test results), .1% THC, and .1% CBC (cannabichromene).

The warned CBD companies have fifteen days to show the FDA how they are complying with the warning letters. “Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction,” the FDA warns.

Medical marijuana experts suggest patients considering CBD treatment to instead seek CBD-rich strains of cannabis grown in states that allow medical marijuana, such as Colorado, who also require independent labratory testing of all marijuana products.

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