CDB Supplements Next On FDA's Investigational New Drug Warning List

The agency published warnings to four firms marketing supplements containing CDB ingredients with claims to treat or cure cancer made in statements including testimonials on their websites for products varying from oils, capsules, tinctures and lotions to snacks including gummies and lollipops.

FDA for the second consecutive day, and for the second time in 20 months about cannabidiol products, on Nov. 1 announced warnings to dietary supplement firms that investigational new drug studies of an ingredient precludes its use in dietary supplements.

The agency published warnings to four firms marketing supplements containing CDB ingredients with claims to treat or cure cancer made in statements including testimonials on their websites. The firms – Green Roads of Florida LLC, Alurent Inc., That’s Natural! Marketing & Consulting and Stanley Brothers Social Enterprises LLC – market products that include CDB but not the psychoactive tetrahydrocannabinol ingredient in cannabis and that vary from oils, capsules, tinctures and lotions to snacks including gummies and lollipops and dissolving compounds.

In a statement from the office of Commissioner Scott Gottlieb, FDA said the firms' use their "online platforms to make unfounded claims about their products' ability to limit, treat or cure cancer and other serious diseases."

CBD-containing supplements FDA found making claims of treating cancer and other diseases include oils, such as That's Natural!, above, and products in less common formats, such as Greenroads Health's gummies, below.

Additionally, each warning letter from divisions of FDA's Office of Regulatory Affairs explains that marketing any supplement or food product formulated with a drug ingredient that has been studied in substantial clinical investigations that have been public is a violation of FDA regulations.

"The existence of substantial clinical investigations regarding CBD has been made public," each letter states.

The letters note the clinical investigations include GW Pharmaceuticals PLC’s studies with the drugs Epidiolex, proposed as a treatment for a rare form of child-onset epilepsy, and Sativex, which is approved outside the US for spasticity associated with multiple sclerosis. (Also see "Cannabinoid Market Snapshot: GW's Epilepsy Success Bodes Well" - Scrip, 25 Nov, 2016.),

ORA made the same investigational new drug explanations in warning letters published Oct. 31 to three firms marketing products labeled as supplements but containing selective androgen receptor modulators, SARMs, anabolic steroid-like ingredients that have the potential to increase the risk of heart attack and stroke. (Also see "SARMs Spells Latest 'Synthetic Steroids' FDA Finds In Supplements" - HBW Insight, 31 Oct, 2017.)

IND Noted After Earlier Cancer Claim Warnings

The investigation of a dietary ingredient as a new drug does not preclude its use in a supplement or food product if the use began before any substantial clinical investigations involving the drug were instituted. Some firms or other parties interested in marketing CBD-containing dietary supplements using compliant claims could have an argument that their products are not violative.

Hoisting the IND rule to render CBD-containing supplements noncompliant, as FDA initially did in April 2016, could spur notification to the agency of proof that CBD was available in the US in products marketed as supplements before the substance was approved for IND studies. (Also see "FDA's Initial IND Warnings For CBD Supplements Could Ignite Regulatory Test" - Pink Sheet, 16 Feb, 2016.)

The IND provision wasn't noted, though, when FDA in March 2015 warned seven firms on cancer and other violative claims for their CDB supplements. (Also see "Cannabis Supplements’ Cancer Claims Spark FDA Warnings, Policy Point" - Pink Sheet, 5 Mar, 2015.)

FDA added the IND information to its policy on whether supplements containing cannabis-derived ingredients are adulterated in a guidance published a month after those warnings. The guidance came amid rapid market growth for supplement products made with cannabis- or hemp-derived ingredients in addition to an increase in states allowing sales of medical marijuana or of small amounts for personal use.

The market growth, some stakeholders observe, makes removing all consumer health products containing cannabis-derived ingredients unlikely.

Gummies And Wax, Cancer And Hearing Loss

The variety of products identified in the most recent CDB-related warning letters attests to the market growth.

Green Roads markets CBD supplements in common oil, tincture and capsule formats in addition to less common teas, gummies, lollipops and creams. The firm, which distributes products under the Greenroads Health brand from Pembrooke Pines, Fla., also offers CDB supplements in still rarer formats of "Shatter," "Dab Wax," "Dab Crystal" and "CBDreem (Cannabidiol syrup)," according to the letter submitted by ORA's Office of Human and Animal Food Operations East Division IV Compliance Branch in San Jan, Puerto Rico.

The letter states that violative claims found on Green Roads' website, which had been accessible on Nov. 1 before it was closed due to "scheduled maintenance," included:

• CBD has "anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow”;
• “The following are some of the many ailments CBD oil can potentially be therapeutic for: asthma, Alzheimer’s disease, arthritis, autism, bipolar disorder, various types of cancer . . .”;
• “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease…”

For Alurent Inc., ORA's Office of Human and Animal Food Division 5 West in Alameda, Calif., stated in the warning that the El Dorado Hills, Calif., firm's websites marketing its Natural Alchemist brand CDB capsules and oils featured claims including:

• “Combats tumor and cancer cells”;
• “Cannabinoids are found to have particular application . . . in limiting neurological damage following stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease”;
• “Study: Cannabinoids a Potential Treatment Option for Chemotherapy-Induced Hearing Loss.”

Bosom Lotion And Charlotte's Web

That's Natural distributes products it calls "CBD All-Natural Hemp Oil,” “Bosom Lotion Potion” and “CBD-Rich Healing Crème” from Pueblo, Colo. Its website featured testimonials including “scientific research by doctors have shown it actually kills cancer cells and provides a protective coating around our brain cells” and “as a Type 1 diabetic, my blood sugars have noticeably leveled off.”

For terpenes, the fragrant oils in cannabis, That's Natural's claims include that separate ingredients are "anti-tumor." And generally for CBD oil, the website claims it "makes cancer cells commit ‘suicide’ without killing other cells” and "may have therapeutic effects for the human body, through the Endocannabinoid System (ECS). This includes treating tumors and cancer-related pain," according to the warning submitted by ORA's Division of Pharmaceutical Quality Operations IV in Irvine, Calif.

DPQO IV's letter to Stanley Brothers Social Enterprises in Colorado Springs, Colo., states that claims on websites for its Charlotte's Web Everyday brand CBD supplements in capsules and oils included:

• “A patient of mine uses this for Cancer and it gives lots better relief than prescription drugs!”;
• “My dear ex mother in law has been diagnosed with late stage pancreatic cancer. This is the only thing that gives her relief”;
• “I have gone from basically clinically depressed to feeling ok about life in general. It’s been a miracle for me compared to how I use to feel”;
• “Current studies have reported that CBD is showing promise in how oncologists are looking to treat breast, glioma, Leukemia, thyroid, colon and lung cancer.”

ORA also warned Stanley Brothers about disease claims made for its products on social media platforms. The letter notes these Facebook posts in June 2016: “Who can write an rx script for my 17 year old son with dx PDD-NOS/Autism? Where can I purchase CW?” CW Hemp replied: “Charlotte’s Web . . . [y]ou can order right from our site at cwhemp.com . . . you do not need a RX to buy Charlotte’s Web."

Each firm also was warned that because their products are deemed drugs by their indications and formulations, they are misbranded due to failing to bear adequate directions for their use.