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July 23, 2025 By: Asa Waldstein

When Nutrient Claims Become Disease Statements

Takeaway -

Carefully review all marketing materials

This warning letter involves a nut butter company that was making implied and express cancer claims on its website and product labels. This is an extreme example of what not to do and there are some good learning opportunities.

Ingredient claims are product claims. Here, FDA references ingredient claims being used to help with cancer. These claims appear on the product page but even if they were separated from a shopping cart, such as in an ingredient blog, they would have likely attracted a warning letter.

From warning letter: “[R]ecent studies have highlighted the potential of Brazil nuts, almonds, and cashews (ingredients in your Inspiration Butter) in fighting against cancer, thanks to their antioxidant properties and beneficial nutrients.”

Claims about nutrients are product claims. This is interesting, as the statement references omegas and polyphenols, which the product contains, as fighting diseases. This is an possible example of what can go wrong when your marketing team is also your compliance team. Also, this was written on the product label! Oye vey!

From warning letter: “(From the image of your product label) “THE POWER OF NUTRIENTS: Our uniquely tasty multi-nut butter blend contains Omega 3-6-9 fats with powerful antioxidant polyphenols, which studies have shown may . . . assist in the fight against certain diseases*.”

Mission statements are marketing claims. This is pretty obvious as the company states they make products for people fighting cancer. In the past FDA has also cited mission statement related claims when they tie in product such as ‘I had cancer, and this inspired me to make these products.’

From warning letter: “OUR MISSION: We craft calorie-dense and nutrient-intense foods for people fighting cancer . . .. Organic BRAVEZIL BUTTER supports our mission of bringing naturally nutritious foods to market which ‘Fuel the Fight’.”

If you market products online, you are on FDA’s radar. This company appears to be a small food manufacturer but since they advertise products on their website, it makes it easy for anyone with a computer, including FDA to find them. Here’s a post about this. 

Expect more “lower effort” warning letters. FDA’s budget unfortunately has suffered budgetary cutbacks. Web-surfing warning letters like this don’t require resource intensive in-person visits or product testing and we will see more of these in the future.

To be fair this company seems to be well intentioned but they just have no idea about marketing compliance. This is one of the reasons why I enjoy writing Warning Letter Wednesday; to help get the world out about the basics, the nuances, the complexities and the best practices when marketing natural products. I really aim to help demystify the sometimes-confusing world of supplement and food marketing and I hope you enjoy it!

Read the full warning letter here

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices