FDA and FTC Joint Warning Letters Target Amazon Affiliates Making False COVID-19 ClaimsFDA and FTC Joint Warning Letters Target Amazon Affiliates Making False COVID-19 ClaimsEarlier this week, federal regulators continued their efforts to combat the spread of products featuring allegedly false and misleading claims that products can diagnose, treat, cure, or prevent COVID-19.  In warning letters issued to CBD Gaze, Alternavita, Musthavemom.com, and Careful Cents LLC, the agencies identify the respective recipients as participants in the Amazon Affiliate program.  Amazon Affiliates are marketers who earn commissions by promoting products sold on Amazon.  The letters state that the products at issue, which include essential oils, grapefruit seed extracts, cod liver oil, and others, feature false treatment and prevention claims such as the following:

  • CBD Gaze:  “Find the best CBD Oil to help fight Coronavirus.”
  • Alternavita:  “4 Proven Ways To Protect Yourself Against Coronavirus,” you represent that “Everyone is concerned about Coronavirus and looking for ways to protect themselves,” and then state the following:

“Grapefruit Seed Extract If you want a little extra daily protection GSE is a safe antibiotic . . . [Amazon associate link].”

  • Musthavemom.com:  “NATURAL REMEDIES FOR CORONAVIRUS. . .There are plenty of things you can do to boost your immune system and fight off any virus including coronavirus. Here are a few!”  … “2. Vitamin D . . . This important vitamin plays a crucial role in immune health. Being deficient in Vitamin D can increase your risk of infection. I recommend this brand of Vitamin D [Amazon associates link] and starting at a minimum dose of 5,000 IU.” [from your website https://musthavemom.com/coronavirus-prevention-treatment-plan/]
  • Careful Cents LLC:  “How to Boost Your Immune System Naturally With Essential Oils to Fight Coronavirus” you state: “Can you use essential oils to boost your immune system and fight coronavirus? Yes! Essential oils are one of the best tools to strengthen your immune system naturally . . .”

The letters state that the products are unapproved new drugs and misbranded pursuant to the Food Drug and Cosmetic Act.  Causing the introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).  The letters also state that “it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.  For COVID-19, no such study is currently known to exist for the product identified above.  Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.”

What’s the lesson?  The difference between these letters and the warning letters that FDA and the FTC issued earlier this year is that these are targeted not to the company making the product or even the retail platform on which they are sold.  They were sent to the middleman marketer, who likely does not produce or possess the product, but who is promoting and profiting from its sale.  This is consistent with the FTC’s letters to product influencers in other marketing contexts but is a departure from FDA’s typical enforcement approach.  Although we have seen FDA pursue retailers (particularly online ones), FDA has not made pursuit of marketing affiliates a priority.  Clearly, regulators want affiliate marketers (Amazon or otherwise) to understand that they are not immune from enforcement if they are making aggressive or unsubstantiated health claims.

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Today, the FTC issued warning letters to three companies selling CBD products.  The companies, which FTC did not identify publicly, allegedly illegally advertised CBD products as being able to treat or cure serious diseases and health conditions without competent and reliable scientific evidence to support such claims. As we have written about previously, FTC and the FDA issued similar joint warning letters to three other CBD sellers earlier this year.

According to the FTC’s press release, the companies claimed their products could cure serious diseases such as cancer, alzheimer’s, fibromyalgia, and multiple sclerosis.  At least one company’s website, however, took it a step further by claiming “CBD ‘works like magic’ to relieve ‘even the most agonizing pain’ better than prescription opioid painkillers” and “the company . . . has participated in ‘thousands of hours of research’ with Harvard researchers.”

The letters directed the recipient companies to review all claims, including testimonials, to ensure they are supported by competent and reliable scientific evidence.  As readers of this blog likely know, advertisers are required to substantiate all objectively provable claims and cannot use testimonials as a means to make claims that they cannot otherwise substantiate. Given that cannabis, including hemp, was a controlled substance for decades, there has been limited research conducted to date.  Put another way, although users may have experienced favorable results, this does not excuse the advertiser from properly substantiating their claims.

Get a quick update on enforcement and related CBD issues in our webinar, Wednesday, September 11, at 12:30 pm Eastern.  Here is a link to the registration page.

The FDA and FTC jointly issued warning letters to three companies selling CBD products online. The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”). Although this is the first time the FDA and FTC have issued joint warning letters relating to CBD, the FDA has been involved in CBD enforcement for the past few years.

Since the passing of the 2018 Farm Bill, which descheduled hemp and hemp derivatives under the federal Controlled Substances Act, the FDA has become the primary federal regulator relative to foods, drugs, cosmetics, and dietary supplements that contain CBD from hemp. The FDA’s most visible enforcement on CBD products to date has been in the form of warning letters issued to online retailers of products labeled as dietary supplements that feature aggressive disease treatment claims. The FDA also tested CBD products in conjunction with warning letters issued in 2015 and 2016 to determine whether they contained the CBD levels listed on the labels.

In the letters from last week, the FDA turned its focus onto various CBD products marketed online as “drugs,” including “CBD Salve,” “CBD Oil,” “CBD for Dogs,” “Hemp Oil,” “CBD Softgels,” “Liquid Gold Gummies (Sweet Mix),” “Liquid Gold Gummies (Sour Mix),” and “blue CBD Crystals Isolate 1500mg.” The FDA determined that the companies’ websites contained claims about their CBD products that established them as unapproved “drugs” under section 201(g)(1) of the FDCA. The letters also referenced the FTC’s substantiation standard, stating the FTC had concerns that certain efficacy claims that were made may not be substantiated by competent and reliable scientific evidence. They also warned that violations of the FTCA may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order, possibly including a requirement to pay back money to consumers.

As noted above, these letters are unique, as it is the first time the FDA has issued a joint FDA/FTC warning letter relating to CBD. This is also the first time the FDA has referenced the FTC’s substantiation standard or threaten any specific penalty for violations of the FTCA. For companies marketing CBD, it is important to keep in mind that although the market has flourished despite a host of regulatory uncertainties, it is the regulators’ opinion that the rules regarding advertising and health claims are clear. Competent and reliable scientific evidence remains the standard.

Over the last few years, however, the FTC’s health claim enforcement has featured several false cure-type products. Cases against Regenerative Medical Group, Cellmark, iV Bars, and Nobetes challenged unproven representations for products promising to treat Parkinson’s disease, macular degeneration, cancer, multiple sclerosis, and diabetes. Although we have yet to see the FTC announce any settlements relating to CBD products, these letters signal that FDA is not alone in its concern over aggressive CBD treatment claims.

The warning letters can be found here:

Any parent who has tried in vain to soothe a child suffering from a painful ear infection or comfort a teething baby knows that feeling of desperation when you may be willing to try just about anything to get the crying to stop.  Both yours and the child’s…

It is just this issue that appears to have caught the attention of the FDA and FTC as the target for their most recent CBD enforcement.  Similar to the three CBD companies previously targeted, Rooted Apothecary made allegedly unsubstantiated claims that its products could prevent, diagnose, treat, or cure serious diseases.  Particularly concerning this time, however, was the fact that some of the claims targeted use on infants and children.

Some examples of the company’s claims included the following:

  •  “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
  • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
  •  “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”

Once again, CBD marketers should take a lesson from the rules that apply to conventional products, and not just as to claim substantiation.  Product claims that target vulnerable populations, such as infants, children, or the elderly, are likely to receive greater scrutiny regardless of the product type.  These populations (along with sleep-deprived parents of young children) may be more susceptible to believing outrageous claims and less likely or able to articulate it if a product is not working or is potentially causing harm.  And that – more than the ear infection – is reason for concern.

For guidance on claim substantiation and health marketing considerations, check out our affiliated blog, Ad Law Access.

On August 9, Governor Phil Murphy signed into law Assembly Bill 5322, establishing the state’s program for cultivation, handling, processing, transport, and sale of hemp.  The bill also repeals the New Jersey Industrial Hemp Pilot Program, which was passed in late 2018.  Here are some key takeaways from the new law:

  • Under the new law, titled the New Jersey Hemp Farming Act, “hemp” is defined the plant Cannabis sativa L. and any part of that plant, including the seeds of the plant and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (“THC”) concentration of not more than 0.3 percent on a dry weight basis.
  • Hemp and hemp-derived cannabinoids, including cannabidiol (“CBD”), are not considered controlled substances or adulterants.
  • Derivatives of hemp, including CBD, may be added to cosmetics, personal care products, and products intended for human or animal consumption to the maximum extent permitted by federal law (As we’ve written about here, it is FDA’s position that CBD-infused foods are in violation of the Food, Drug and Cosmetic Act).
  • Farmers must receive a license to cultivate, handle, or process hemp from the New Jersey Department of Agriculture (“NJDA”).  However, subject to future regulations, it is lawful to sell legally-produced hemp products in New Jersey without a license.
  • Retail sales of hemp products processed outside New Jersey may be conducted in the New Jersey when the products and the hemp used in the products were processed and cultivated legally in another state or jurisdiction that has the same or substantially similar requirements for processing hemp products or cultivating hemp.

No later than 90 days after the bill was passed, NJDA must adopt interim regulations to implement the new law. The regulations will be effective immediately upon filing with the New Jersey Office of Administrative Law and will be in effect for a period not to exceed 18 months, and thereafter, be amended, adopted, or readopted by the NJDA in accordance with the provisions of the “Administrative Procedure Act.” After adoption of the regulations, NJDA will also submit the regulations for federal approval from the United States Department of Agriculture (“USDA”) as a state plan.  Stay tuned here for further updates.

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat post-traumatic stress disorder, lupus, cancer, and other conditions rendered the products unapproved new drugs.

This February, FDA again turned its attention to CBD products, issuing eight new warning letters. For the first time in an enforcement context, FDA contended that CBD products fail to meet the FDCA definition of a “dietary supplement.” The agency explained as follows:

FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.

The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 C.F.R. § 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. 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 under section 201(ff)(3)(B)(ii) of the FD&C Act, but you may present the agency with any evidence that has bearing on this issue.

The cited portion of the “dietary supplement” definition is discussed in FDA’s controversial 2011 draft guidance on new dietary ingredients. FDA committed to revising that guidance in 2012. Revised guidance has yet to be released.

In each of the new warning letters, FDA again identified claims that it believed rendered products unapproved new drugs. This time, however, identified claims were drawn from not only company websites, but also product descriptions on Etsy and company posts on Facebook, Twitter, and Pinterest.  We discussed FDA and FTC regulation of social media in an article published in Nutritional Outlook. In general, regulators treat social media posts by companies the same as any other labeling or advertising. Regulators may treat posts by consumers as labeling or advertising where a company “likes,” comments on, or republishes a post.