Dietary Supplements Case Studies in Claims Substantiation

April 6, 2011

4 Min Read
Dietary Supplements Case Studies in Claims Substantiation

by Steven M. Weisman, Ph.D.



With so many companies competing in the nutraceutical market, the need for unique and innovative dietary supplement products and claims has never been greater. However, adequate understanding of the scientific rationale for any dietary supplement product claims is critical for avoiding regulatory and litigation risks. Such understanding requires a rigorous and comprehensive approach and should consider multiple factors.

The following Claim Substantiation Assessment is a quick way to determine whether a claim is adequately substantiated with scientific rationale. Importantly, it is not meant to replace a thorough scientific evaluation of your dietary supplement claims.

Answering these simple questions will provide a better idea of how substantiation behind a given claim would stand up under FDA/FTC inquiry.



Claim Substantiation Assessment - Section 1

Directions: Answer all of the following questions for each individual product claim.



1. Which of the following is the main support for the claim?

  1. A consumer testimonial and a study conducted in animals

  2. A published review and an in vitro study

  3. Several randomized, double blind, placebo-controlled trials



2. Which of the following research has been considered?

  1. Favorable research only

  2. Mostly favorable and some unfavorable

  3. Both favorable and unfavorable research equally (i.e., the totality of the evidence)

3. In what manner have you disclosed the claim's qualifying information in the product's advertisement?

  1. There is no qualifying information

  2. It is included, but not emphasized

  3. It is clearly and prominently disclosed using clear language and large text

4. In what manner have reasonable claim interpretations been considered?

  1. Only the literal message of the claim has been substantiated

  2. Some possible interpretations have been substantiated

  3. All possible interpretations have been substantiated

5. Which statements of the claims are substantiated by competent and reliable scientific evidence?

  1. Some of them

  2. Most of them

  3. All of them


Are your claims substantiated by clinical studies? If so, continue to section 2 (on the next page). If not, continue to Results.



Claim Substantiation AssessmentSection 2



6. Which of the following factors are specified in the study?

  1. Ingredients/source

  2. Serving size/dose

  3. Both A and B

7. How similar are the study population and potential consumers of the product?

  1. Same age

  2. Same sex

  3. Same age and sex

8. Which answer most applies to the research results of all studies being considered?

  1. Not applicable (there is only one study)

  2. They have been replicated in independent studies, but there are also some studies that had different results

  3. They have been replicated in independently conducted studies

Results are on the next page...


 

Results



To determine results:

1 point for each question answered A

2 points for each question answered B

3 points for each question answered C



If you only completed Section 1, and the total is:


  • Less than 7: WARNINGthis claim is not adequately substantiated. Consider conducting a comprehensive review. In many cases of FTC/FDA inquiry, the assistance of a group specializing in dietary supplement claim substantiation has helped companies avoid millions of dollars in fines.

  • 7 to 12: Be careful; better scientific substantiation may be needed for this claim.

  • Greater than 12: Congratulations! It is probable the product is adequately substantiated by competent and reliable scientific evidence.



If you completed both Section 1 and 2, and the total is:



  • Less than 12: WARNINGthis claim is not adequately substantiated. Consider conducting a comprehensive review or working with a group specializing in claims substantiation.

  • 12 to 19: Be careful; better scientific substantiation may be needed for this claim.

  • Greater than 20: Congratulations! It is probable the product is adequately substantiated by competent and reliable scientific evidence.



Scientific rationale behind claims substantiation can make the difference between winning and losing in a regulatory challenge. Taking the time to ensure your dietary supplement claims are protected from increased scrutiny by effectively managing the science behind the claims and making it a leverageable asset is simply smart business.



Steven M. Weisman, Ph.D., is the head of Global Healthcare Products for Innovative Science Solutions LLC in Morristown, NJ.

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