FDA Fails to Call Attention to Consumer Fraud in CBD Hemp Market

Medicine Cannabis Now Magazine

A year ago last February, the FDA sent out the first of numerous warning letters to 18 companies marketing cannabidiol (CBD) products, regarding claims they were making about their products, in the hopes of protecting an unwitting and unknowing public, many naive to what CBD actually is.

The letters that the companies received allege that they are marketing their products to cure or treat diseases, in other words, as drugs, without them going through the appropriate approval process. Some of these companies were selling to humans, others to animals and some selling to both. Interestingly, the letters do not mention a much bigger issue with the products, that many contained no CBD at all and few (if any) contained remotely close to the advertised amount, even the media missed this detail at the time. The only CBD product the FDA found to have more than 2 percent CBD was Canna-Pet MaxCBD Capsules for Dogs, with a whopping 2.5 percent CBD, at the price of $37.99 for a mere 10 pills.

According to FDA spokesman, Jeff Ventura, “the FDA has not approved any drug product containing cannabidiol, for any indication, meaning none of these products have been determined by FDA to be safe or effective for their intended indications.” The reason for the letters is because 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,” especially when 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.”

This year the FDA sent out letters to 22 companies, none of them were repeats from last year. The letters were very similar to the previous batch, stating that CBD was not able to be marketed as a dietary supplement and was clearly a drug. Where the letters differed, was that these new letters brought up Investigational New Drug applications and GW Pharmaceutical’s “investigations regarding Sativex and Epidiolex.” The 2016 letters also issued a challenge to the cannabis community, specifically the companies in question. The “FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition… but you may present FDA with any evidence that has bearing on this issue.” In other words, show us your research and if we like it maybe we will change out minds.

Just like in 2015, the majority of products tested didn’t have remotely close to the advertised levels of CBD. Only one product actually had the advertised level of CBD, which was PainBomb’s iHempCBD Filtered CBD Hemp Oil, which had a staggering 35 percent CBD, also making it the highest tester the FDA has sent a letter to so far.

Hemp Industry Association Responds:

The Hemp Industry Association is a “non-profit trade association representing businesses, farmers, researchers and investors working with industrial hemp.” As early as 2014, the HIA was doing their best to clarify the differences between hemp oil, which is oil obtained from “pressing hemp seeds that contain low levels of CBD, typically less than 25 parts per million (ppm),” and CBD oils which is an oil that is very rich in CBD (150,000 ppm) and can be derived from either hemp or marijuana cultivars of the cannabis plant. For the HIA, this was personal, and goes back to a 2001 showdown with the DEA where they attempted to “ban import and commerce of hemp seed and oil food” by “claiming these food products where controlled Schedule I substances.”

The HIA was able to successfully sue the DEA, “unequivocally establishing hemp seed, oil and protein as entirely legal to import, process, sell and consume in the U.S.” The HIA, understandably, is a bit upset at these new companies joining the party late and threatening to upset the apple cart by claiming something is what it is not, that is, that CBD-oil is nothing more than already legal hemp oil. That said, the HIA embraces Section 7606 of the Farm Bill which allows access to hemp for research purposes and defines hemp as having less than 0.3 percent THC, they just want the distribution and marketing done legally and responsibly (as any trade association would).

After last year’s letters the HIA, in partnership with Americans for Safe Access, issued guidelines on the “Best Practices for Regulation, Labeling and Manufacturing of Medicinal Cannabis and Hemp Products” to try and mitigate the second barrage of letters we just saw this year. In response to this year’s letters, the HIA had this to say:

“It is the position of the HIA that legal hemp products containing CBD were marketed as foods and dietary supplements long before cannabidiol formulations were submitted to the FDA for testing as a ‘new drug.’ As such, CBD products are exempt from laws that preclude CBDs from product status as dietary supplements pending ‘new drug’ approval by the FDA.”

Paige Figi Weighs in For Charlotte’s Web Hemp Products

Paige Figi is the mother of Charlotte Figi, the girl made famous by Dr. Sanjay Gupta’s three part TV series, “Weed,” for her use of a CBD-rich strain of cannabis to treat her epileptic seizures caused by Dravet syndrome. Last year, US News spoke to Paige Figi about the 2015 crackdown, who was “extremely encouraged that they’re taking a look at this from the consumer point of view of safety.” For Figi, consumer safety is paramount, “that’s exactly what I stand for and what I want.”

The CBD-rich strain which Charlotte has been using, called Charlotte’s Web, is distributed by the for-profit CW Botanicals (formerly the Stanley Brothers Social Enterprises), and their non-profit affiliate The Realm of Caring (RoC). Presently, CW Botanicals and the RoC distribute their medicine to nine states and internationally to Poland and the United Kingdom and all Charlotte’s Web hemp products are tested by a third party, independent lab before being sold. Charlotte’s Web is no longer just one strain, as “several phenotypic strains” now exist “which have low enough THC to be considered hemp,” rather than meeting the government’s definition of hemp as set out in Section 7606 of the Farm Bill. This implies that there are phenotypes that may, and likely do, have higher amounts of THC, crossing the line to become Charlotte’s Web cannabis plants; but like anyone trying to responsibly grow CBD-rich medicine, these recessive phenotypes will get culled rather than grown out.

Robert Hoban Represents Major Hemp-CBD Clients

Bob Hoban is one of the partners at the law firm Hoban & Feola, LLC, a firm which serves cannabis industry clients in 13 U.S. states and abroad, representing the largest players in the marijuana industry and many of the nation’s largest hemp producers, suppliers and manufacturers. Bob is also a member of the Colorado Department of Agriculture’s Hemp Regulation Advisory Committee, and the Department of Revenue’s MED Rulemaking Committee. Without belabouring the point, Bob is an expert of cannabis law and represents multiple hemp and CBD companies, making him a perfect person to talk to for a more in-depth understanding of the FDA’s letters.

I asked Hoban about sub-section 16 of § 802 Definitions in the Controlled Substances Act (CSA), which is seemingly broadly worded enough to include any piece, part, or molecule of the cannabis plant illegal. Hoban had some very sage wisdom, “A huge exception to the definition of marihuana, is that the stalks, the fibers, and the hurd are not considered marihuana.” Hoban mentioned the case of Hemp Industries Association vs. DEA (2003), which upheld the 9th Circuit court’s previous ruling that the CSA only applies “to synthetic THC, and that any THC occurring naturally within cannabis is banned only if it falls within the Schedule I definition of ‘marijuana.’ That Schedule I definition mentioned is sub-section 16 of the CSA that I mentioned above, which is silent regarding the hurds, stalks and fibers – meaning that anything derived from them should theoretically be legal, including THC, though only in the 9th Circuit. According to Hoban, “CBD is not defined under the CSA or anywhere in federal law, so if it is derived from stalks, fibers, and hurds it is legal.”

I brought up the issue of rampant fraud in the hemp CBD market, where a vast majority of the products questioned by the FDA actually had no CBD, despite labeling which indicated a given dose. Hoban agreed with me that this is a problem, recognizing that  “the hemp CBD industry is modeling on the natural products industry, and bad actors will happen, but they come and go. It’s not acceptable, but it’s a fact.” Hoban put things very eloquently when he asked about bad actors in the CBD market, “Why would you defraud consumers, when you could do things the right way and be a successful business that helps people for decades and decades?” The FDA has a section on their website called “6 Tip-offs to Rip-offs: Don’t Fall for Health Fraud Scams,” which while not specifically mentioning CBD or cannabis is very sage advice for anyone thinking about buying hemp-derived CBD “medicine” over the Internet. For Hoban, the CBD market is “no different from the natural products industry,” and consumers need to be smart because “there are always snake oil salesman,” and absent real government regulations of the market there are few consumer protections in place.

Do you feel safe buying CBD products? Have you ever purchased a CBD product that turned out to be something different from what was advertised? Tell us about your experiences. 

Mitchell Colbert became a cannabis activist when he was busted for possession at nineteen years old and was inspired to educate others to know their rights. He has written for Weedist, AlterNet, High Times, Cannabis Now Magazine and runs a blog called wellsuitedforlife.com. He's a former chapter president of Students for Sensible Drug Policy and was a regional director for 2010's Prop 19 campaign to legalize cannabis in California.
  • John

    The FDA is only going after the companies that are making ridiculous claims and posting inaccurate test results. Why do you think they didn’t send a letter to CW, Blue Bird, Mary’s or Dixie!? There are definitely companies that are making an effort to play by the rules, are testing everything and not making any claims – and the FDA is not touching them.

    • PainBomb+CBD contains approximately 138 mg of cannabidiol per 2 oz. jar, vs. 50 mg for most salves. Of that 138 mg, approximately 25 are actual CBD, compared to 6.5 to 8 mg of actual CBD in
      products such as Cibaderm™, PlusCBD™, and Beauty Defined™.
      Double that amount for the 4 oz. jar, 276 mg, and 50 actual CBD.
      PainBomb also contains 27 essential oils and arnica, St. John’s Wort, and green tea extract,which comprise 7% of the formula. Also includes pharma-grade DMSO, Aloe,Yucca Extract, MSM, and CBD, all in a base of organic extra virgin coconut & olive oils,
      organic hemp oil (All Non-GMO), and organic grapeseed oil and beeswax. This formula is far superior to any salve on the market.

  • Richard Rose

    You asked a hemp fiber association it’s opinion on CBD? They’ve been gunning for it for years. Ask the Medicinal Hemp Association and get a better answer.

  • Doug

    did you actually run the numbers on this years tests results Mitchell? I DID, I got out the calculator, and EVERY MAJOR BRAND WAS ALMOST SPOT ON. Where do you get your data that only ONE passed? I ran those numbers myself, you are mistaken. You should do the mg/gram/liquid oz conversions, and revisit your comment. In fact, this years tests show that ALL of the known brands of CBD on the market contain exactly what the label specifies in terms of Mg’s per bottle. Well known distributors such as Endoca, and US hemp oil, that supply half the industry, tested right on the tits. do the math. Those that know these numbers only need glance at them to know if they are in spec or not as far as mg/fl oz. I looked at these with another formulator and he was like, oh, that one is a tad low, that’s right on, that’s right on and he didn’t even have to crunch the figures like I did, as he is used to seeing what range those numbers should fall in. I work in the industry and have for over 2 years now. the VAST amount of products sold from well known brands and suppliers are good products. I would know, I have used most of them and I am a 30 year cannabis guy who can tell what 20mg’s of CBD should feel like. Do the math Mitchell. You must do the mg/ gram to fluid oz conversions. Why do you think there was NO mention of cannabinoid counts this year, when there was a huge stink last year? Because they were almost ALL right on, besides noname brands like morguejuice, and who would buy that anyway? Dose was a bit low, but there are good reasons for that and those numbers can be easily explained. For instance, they stopped selling coconut blends as anyone in the industry can tell you the problems with getting a consistent blend in coconut oil that resolidifies when shelved. The other product was a 32 oz bonded glycerin product that clots on the shelf. there is no way in hell the lab was able to reblend an entire 32 oz bottle of it, I have seen the product, I have used it. They would need a specialized tech to even test it properly. Sorry Mitchell, but you are crying wolf here. If you want to point out the, I think 2 or 3 companies that actually did fail, then fine. but don’t get out the same paintbrush for the companies that passed with flying colors. Suppliers like Endoca and US Hemp oil supply tons of companies with their bases. They are imported legally, they are tested after extraction, no one using those bases is putting out bunk product.

    • I got my numbers from the FDA:

      2015 – http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm
      2016 – http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm

      You want to look at the Lab Results: CBD column and you will see that nearly none have any detectable CBD. I feel like the FDA is the authority on the letters they sent out and what they found.

      Where did you get your data, Doug?

      • Really? You trust the FDA? That’s special, Mitchell. Read my response to their “Warning Letter”. http://www.paincbd.com — Go to the page: FDA’s Threat To You.
        Also, I finally heard from them last week, they said that if I want the information on the lab that tested the cbd products, I have to file a FOIA request. That’s how transparent they are.

    • Thank you, Doug. PainBomb+CBD actually contains closer to 27 mg in the 2 oz, I claim 25 because that’s what I started with.