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The Way You Must Market A Non-FDA Approved Product: 2021

Sep 17, 2021

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Times have changed since the FDA has cracked down on the natural alternatives that the pharmaceuticals are trying to make chemical versions of… Therefore, until that corruption gets under control, we have to walk a unique line for the time being. Here is an 2021 updated post on how you should market CBD, Kratom and the like.

The FDA’s Crackdown

It is important to state that the FDA’s main concern is that these high risk products (kratom, CBD, kava, etc) have not been shown to be either safe or effective (debatable, I know), and ultimately fears that “deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

“Recognized” here is defined as “FDA Approved”, of course.

Nathalie Bougenies, a lawyer from Above the Law explained it this way:

“The FDA’s jurisdiction is triggered by a product’s intended use. Generally, the FDA determines intended use based on claims made by the product’s manufacturers and distributors, which are often contained on the product’s labeling or in promotional or advertising materials. If a company expressly or implicitly states that its product can be used to diagnose, cure, mitigate, treat, or prevent a disease, or affects the bodily structure or function of the end-use consumer, the FDA will likely conclude that the product is a drug under the Food, Drug and Cosmetic Act (FDCA).”

Now if you are like me, “medical claims” were an easy thing to avoid if you included words like might, could, has been known to, etc. However, implying a bodily reaction in any way is now considered a “medical claim” these days.

Phrases like:

  1. “CBD…Inhibits cancer cell growth […] Treats psoriasis.”

  2. “CBD has demonstrable neuroprotective and neurogenic effects, and it’s anticancer properties are currently being investigated at many academic and independent research centers in the United States and worldwide.”

  3. “The Benefits of CBD Oil for ADHD . . . It’s not unusual for people with ADHD to feel anxious and on the edge. CBD is known for its anti-anxiety properties that can promote relaxation and stress relief. It can also help to restore focus and ability to concentrate on specific tasks, as well as reduce impulsivity.”

  4. “CBD has also been shown to be effective in treating Parkinson’s disease.”

  5. “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”

  6. “Helps reduce…Inflammation…Arthritis…Back Pain…Muscle Aches…Joints.”

  7. “A 2018 study showed that CBD offers quick relief of depression and anxiety symptoms and that the residual effects can last up to seven days.”

  8. “Can CBD help with Corona Virus? Possibly! But one thing is for sure, it will help you relax when everyone else is panicking.”

How do you market a high risk, non-FDA approved natural alternative product then?

You can’t. Well, you pretty much can’t. If you watch your legit competitors, you will notice that they are focusing and talking about the cleanliness and purity of the product itself, how it is derived, produced, harvested, tested, etc.  As for the details of effects, they have figured out (because marketers like me have educated them) how to go around the “rules” by pursuing influencers to do reviews/videos, bloggers to do posts, and customers to write reviews. They must rely on second-hand marketing, where they can say all they want about the experience of said product.

3 Things to Do to Start Marketing your High Risk Product

  1. Reach out to social media influencers who talk about products like yours. Ask them to review your product by sending them free samples. Don’t be picky. Find any influencer who would be willing, regardless of the amount of followers they have.

  2. Seek out reviews from your customers. Ask them to submit a review and add those specific reviews to your product pages. Give them an incentive like a one-time use of a promo code.

  3. Seek out bloggers to write a blog post/review of your product. Avoid having a blog of your own under your branding. That ties you too close to making medical claims yourself, regardless of it not being with the product itself or on a product page. You as a business cannot make any claims. Find other blogs not under your business umbrella.

Conclusion: Be careful

I’ve had many kratom and CBD clients that reach out to me, frustrating with seeing their competitors doing great with marketing, making all kinds of claims. Trust me, it will catch up with them. I have worked with some of the top kratom vendors at their time who were shut down because it caught up with them. It is only a matter of time for them. Is that right? No, but such is the situation…until the corruption is caught and ends when it comes to the war on natural alternatives.


#Branding #medicalclaims #FDA #marketing #rules #Vendors

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