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August 21, 2024 By: Asa Waldstein

“Reduce Bloating” Claims Lead To NAD Case

Takeaway -

Even lower risk statements can trigger NAD scrutiny

Even lower-risk statements can lead to scrutiny, as we see in this National Advertising Division (NAD) case.

I do not consider any of the claims NAD cited to be high risk, but this shows that even low to mid-risk structure-function claims may attract NAD scrutiny. This, of course, reminds us that all marketing should be substantiated. Here are some of the claims mentioned in the NAD case.

“Relieves symptoms of Menopause”
“Relieves hot flashes”
“Improve sleep quality”
“Reduces bloating and gas”

I am unable to determine if these were on-pack or off-pack claims. This matters (to me) because NAD’s position is that the company did not provide substantiation for these claims partially because there was “no testing on the product itself,” so I am hoping to understand how the company was positioning these claims. If they were on-label, then perhaps a reasonable consumer would think the entire product rather than the ingredients have been tested, but does this also apply to product pages or website statements?

Interestingly, NAD reinforces its position that generally attributing benefits to ingredients may be okay, as we see in these wordy examples.

From NAD case:
“NAD noted that nothing in its decision would prevent (the company) from:
Making claims regarding the ability of fennel and chaste berry to positively affect menopausal symptoms that are supported by the limited findings of the research in evidence.

Making supported claims that describe the traditional or historic use of ashwagandha to support sleep or are carefully qualified to avoid any misleading implication about the product’s efficacy or health benefits.

Describing the traditional or historic use of chamomile in reducing bloating and gas.”

There are two main types of NAD cases. 

1) Competitor challenges: This is where the competitor publicly challenges certain claims a company makes. This is a public process and does require a cost. 

2) Monitoring cases: These are when NAD monitors different types of marketing and brings the cases themselves without a company challenger.

This case was a monitoring case, which means they just happened to come across this company’s marketing.

Read the full case 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