Compliance Lessons: In-Depth Warning Letter Discussion

Updated: Aug 13, 2021

Everyone who knows me is aware of my love of reading warning letters. Gaining insight into enforcement trends can help protect companies from costly regulatory mistakes such as warning letters, administrative action, or even class-action lawsuits (Made in the USA, Natural, THC-Free, Prop 65).

Many warning letter recipients are not bad folks but perhaps just do not know any better. One of the purposes of my free Regulatory Education Series is to educate those looking to raise the bar of ethics and compliance in the industry. Please share this blog or any of my content (with attribution) if it may be of value to your network. We are stronger together!

We are going to have fun reviewing this Cannafyl warning letter which can work as a teaching case to help you understand what the FDA is enforcing. Here are a few learning topics:

  • Social media is advertising

  • COVID-19 implied claims

  • Hashtags are claims such as #cbdforhypertension

  • Reasons to clean up old social media posts

  • Blog are claims

  • Sublingual claims = drug delivery

Quotes from the FDA warning letter are in grey.

We have also reviewed your social media websites

Asa Commentary

  • Social media is referenced in nearly every warning letter. Anything used to market is looked at as an extension of the product label and must be truthful and not misleading.

these websites direct consumers to your website to purchase your products.

Asa Commentary

  • This “material connection” aspect is important to note. This is how the FDA links disease claims to commerce. I ask “If there was no linking to a company shopping cart, would these have been noted in the warning letter”.

Dietary Supplement Labeling

Asa Commentary

  • FDA's boilerplate comments are referenced in CBD warning letters. I will say hemp cannabinoids are not going away and mature companies are looking for ways to comply.

  • Since the FDA regulates based on intended product use is it most ethical and accurate to label ingestible hemp products as supplements? We discuss this here.

On your website homepage ….“CBD MAY HELP YOU WITH . . . Epilepsy[,] Multiple Sclerosis (MS)[,] Amyotrophic Lateral Sclerosis (ALS)[,] Parkinson’s[,] Inflammation[,] Dementia[,] Depression[,] Bacterial Infections[,] Diabetes[,] Rheumatoid Arthritis[,] Substance Abuse/Withdrawal[,] Heart Disease[,] Irritable Bowel Syndrome (IBS) . . . ADHD[,] Schizophrenia”

Asa Commentary

  • Including the word May does not allow companies to make claims. I moderated an AHPA regulatory panel with a top FTC official. He would say “Asa, why is this company making this statement if not to sell products”. This is the lens the FTC and FDA look at marketing statements. I often use this example when educating about how “informational” blogs can easily cross the line into claims.

On your website …. October 10, 2020 blog posting titled “CBD for Breast Cancer”:

· “How CBD helps manage Cancer Growth . . . One of the many reasons Cannafyl decided to make a full spectrum CBD product is the research shown that having all of the cannabinoids working together synergistically provides that extra component that cancer patients fear the most, will my cancer return? Here are a few of the cannabinoids in a full spectrum CBD that are working overtime to inhibit cancer cell growth: CBD: Inhibits Tumor Cell Growth and Cancer Growth[,] CBG: Inhibits Cancer Growth[,] CBGv: Kills Cancer Cells[,] CBC: Inhibits Tumor Cells and Cancer Growth[,] THCa: Inhibits Cancer Cells”

Asa Commentary

  • This is a clear product cancer claim and is extremely high risk. I am asked whether “helps manage” or “may help support” lessens the risk of making claims. The answer is no, as a reasonable consumer would interpret this as a product claim.

  • I have developed a risk-rating system on a scale of 1-5. Here are some examples of words in the 5 of 5 risk category: cancer, COVID, Alzheimer’s, Depression, PTSD and should never be used.

On your website August 21, 2020 blog posting titled Can CBD Help with Opioid Addiction and Withdrawals?”:

· “Can CBD Help Treat Opioid Addiction?” In particular, CBD has been shown to aid in the reduction of drug-seeking behavior. Because CBD may provide relief for a cross-section of symptoms – like . . . mood or anxiety disorders . . . CBD Solutions to Opioid Addiction[,] CBD has been shown to reduce anxiety and control cravings for opioids. . . . Studies have shown CBD may help reduce cravings and reduce opioid withdrawal symptoms. . . . This is why we have decided to create the Cannafyl Relief blend for those who are going through withdrawal symptoms.”

Asa Commentary

  • Reasons to follow warning letter trends. Anyone who reads my blog or pays attention to FDA enforcement trends knows that marketing to those suffering from opioid withdrawal is a no-no. We discuss examples here.

  • We also see anxiety (3.5 of 5 risk rating) showing up in more warning letters. Read about this here.

On your website August 12, 2020 blog posting titled “Researchers Explore how CBD Might Positively Affect COVID-19”:

· “While researchers continue to explore several ways to fight against COVID-19, some are diving a little deeper to see if cannabis derived CBD could possibly benefit those that are suffering from severe forms of this infection. Further research has suggested that CBD is perhaps able to reduce the angiotensin-converting enzyme 2 (ACE2) expression, which is used as a cell receptor to invade human cells. . . . At Cannafyl we formulated a full-spectrum CBD infused with natural terpenes and essential oils giving you all the health benefits that a CBD product can provide, and the great news is you don’t need that much CBD to receive all of the health benefits. This is why we decide