On Monday, FDA announced two warning letters issued to makers of topical CBD products labeled as OTC drugs. Amidst a backdrop of facility inspections that revealed significant good manufacturing compliance concerns, the most important takeaways in this round of CBD enforcement are as follows: FDA does not think that CBD is an appropriate inactive ingredient in OTC drugs, a position that we do not believe the agency has previously articulated publicly. In addition, reaffirming a position that the agency has previously asserted, FDA really frowns on companies using terms such as “FDA registered” to implicitly suggest agency approval.
The warning letters issued to Biolyte Laboratories and Honest Globe Inc. include references to CBD being used to relieve a range of conditions including “…For temporary relief of occasional: . . . minor aches and pains . . . Stiffness of muscles, joints and tissues” (Biolyte Laboratories) and more aggressive statements such as ““What are the Health Benefits of CBD? . . . Benefits of activating the CB1 receptors may include: relieving depression, lowering anxiety, lowering blood pressure, lowering intestinal inflammation and more.” (Honest Globe).
As to both companies, FDA expressed concern that although CBD was listed as an inactive ingredient, the product labeling and the claims discussed in the letters describe CBD as an active pharmaceutical ingredient, i.e., the CBD is responsible for the relief of occasional pain, depression, lowered anxiety, etc. Moreover, given that CBD is recognized to be an approved drug ingredient with pharmacological activity and demonstrated risks, FDA asserted that it cannot be a “safe and suitable” inactive ingredient pursuant to 21 CFR § 330.1(e). As such, FDA deemed both companies’ CBD products to be unapproved new drugs.
FDA also took issue with Honest Globe’s statement that “Elixicure is the world’s first over the counter (OTC) CBD-infused topical pain cream product to have a certified registration with the Food and Drug Administration (FDA)” and “Elixicure is FDA registered and certified by GMP and BSCG” as well as the use of “FDA Registered” on Elixicure’s labels. FDA states as follows:
The assertion of “certified registration with the Food and Drug Administration” and “FDA registered” status in conjunction with your products misleadingly suggests that your “ELIXICURE PAIN RELIEF with CBD” products are approved or endorsed by FDA in some way when this is not true. Any representation that creates an impression of official approval or that a drug is approved or is legally marketable because of registration or listing is misleading and constitutes misbranding.
It appears that FDA’s concerns about Honest Globe had existed for some time. The Honest Globe warning letter references an October 2019 response by the company to a Form 483 finding and then proceeds to explain why the response did not satisfy FDA’s concerns. Yet, on February 1, 2020, Honest Globe issued this press release stating that “Elixicure’s Over-The-Counter Drug Registration has been Certified by the U.S. Food and Drug Administration (FDA) for its Elixicure CBD-Infused Pain Relief products following a successful year-long process…” These dates suggest a possible silence following the company’s response to the 483 until the agency issued the warning letter nearly a year and a half later.
So, what’s the takeaway? These letters serve as reminders of FDA’s previously-stated positions regarding good manufacturing practices and health claims but they also represent a progression of the enforcement to date. Even without the issues discussed above, FDA had serious concerns about these products. By choosing to also highlight its positions about CBD as an inactive ingredient, FDA put industry on notice that while CBD topical products haven’t spent as much time in FDA’s enforcement spotlight as products labeled as dietary supplements, they do not get a pass simply because they are not ingested.
Further, regarding the “certified registration” claims and related implied endorsements of FDA approval particularly those issued after a 483 finding, FDA’s objection to such statements is not new. One lesson, though, (and we don’t know whether this is what happened with Honest Globe but the dates suggest it may have) is that companies that have an open investigation should not assume that non-response from the regulator means that the issues are closed.