In this episode, Wilson talks with Bill Chioffi of Ric Scalzo Institute for Botanical Research.

In it, Wilson and Bill discuss: What the institute is and what its mission, and Wilson asks:

Currently, herbs depending on the level of research and claims that it seeks to make can be classified as a Food, Drug, or Cosmetic, which are all regulated by the FDA. A example of this is Vitamin C can be classified as a drug, if it’s delivered at the proper levels and you use a claim that it helps treat scurvy.

Is the Institute looking to develop botanical drugs, dietary ingredients, or where is the core focus?

What is the importance of the herbal supply chain for the research that you do? How do you think climate change will impact herbs, where they are grown, and their chemical profiles?

Nuherbs had the pleasure of working on several potential botanical drugs and the rigorous qualification and quantification process involved. What are some take key learnings that you think we can adopt in the dietary supplement spaces with regards to dietary ingredients?

https://www.nuherbs.com/articles/how-the-institute-for-botanical-research-furthers-evidenced-based-naturopathic-medicine

Learn more: https://nuherbs.com/

Holly Johnson of the American Herbal Products Association discusses the AHPA’s Tonnage Surveys. These reports present the findings of surveys APHA conducts to quantify annual harvests of certain North American herbs in commerce. In this episode, Holly discusses:

• How the AHPA conducts their surveys, and shares their research methodology, how their studies are conducted, how they take the data from their surveys, and share it with the herbal community.
• Land stewardship and conservation, and sustainable wild harvesting practices.
• A case study on the goldenseal and how the demand for the 45 different species of it grew has developed since the 1990s.
• How to use data in order to cultivate and harvest North American herbs and botanicals.

Listen to the full episode below or read the transcript. https://nuherbs.com/resources/the-importance-of-ahpa-s-tonnage-surveys

Learn more: https://nuherbs.com/

In this episode, Wilson and Asa Waldstein, the principal of the Regulatory Compliance and Supplement Advisory Group and the creator of the #WarningLetterWednesday. Asa and Wilson discuss how herbalists, TCM practitioners, naturopaths, and functional medicine doctors should make claims.

Making Claims

Claims you make as a practitioner are different from claims you make products, as product claims move out the practice scope and more into the realm of marketing (and regulation comes in). It's really important to remember which hat you're wearing when you're doing what. Just because a practitioner or doctor may be able to make a statement in one environment and one setting, doesn't mean they can make it in another setting.

2022 and 2022 Warning on Testimonials and Paid Influencer Claims

The FDA and FTC, they look at really the 30,000 foot view of a company's online persona, and the FDA investigator with probably no knowledge of TCM, Recently, the FDA, FTC and National Advertising Division, sent out 700 letters to 700 individual companies to put them on notice for their product review testimonials.

When using any testimonials, they must be truthful, not misleading. Whoever is giving the testimonial, has to have tried the product before. And testimonials get even dicier when it comes to online statements made about herbal products, especially from social media influencers.

The First Amendment

The First Amendment gives a person the right to say a lot of things. But there's a difference between you as a public citizen and you as a practitioner/commercial marketer and commercial speech. They're regulated quite differently. As a practitioner, when you apply the first amendment to your customers and what they may say about your products or services, your customers are allowed to say whatever they want, that's uncompensated.

Now if you as a practitioner then said, "Oh, that's so cool. I want to use that in my marketing." Then, if that practitioner reposted that or used that on their website, they're substantiating that claim. You’re inadvertently bridging that gap between potentially protected speech and that commercial connection. Oftentimes, you may not know any better.

As a practitioner, you're not responsible for what anyone else says. But the second that you start playing with it or interacting with it, then the government says, "Well, now you're sort of adopting it." This applies to simply sharing it on social media. You can comment on it, on their page, and it could still, if the totality and the sum parts indicate that's what you're trying to do, then you might get in trouble as well.

Listen to the complete episode to learn more about product claims, identifying high risk buzzwords,how to use lower risk words and statements, how to use the FDA Small Entity Compliance Guide to your advantage, and how to use your discretion in one-on-one consultations and selling compounded formulas.

Learn more about Nuherbs: https://nuherbs.com

Subscribe to the Herbal Explorations Podcast: https://open.spotify.com/show/62PaOPlfMbWRmatQJNcHi2?si=7c38397101294d6a

Subscribe Warning Letter Wednesday, a newsletter about FDA and Gov’t Regulation Enforcement Trends: https://www.asawaldstein.com/warning-letter-wednesday

Learn more: https://nuherbs.com/