Nutrasource Blog

The “Do’s and Don’ts” of Claims Substantiation for Dietary Supplements and Natural Health Products

Posted by Santa Al Antwan, Regulatory Affairs Associate on Wed, Nov 23, 2022

In today’s regulatory climate of full accountability and transparency, it is critical to have strong science to back-up any claim made on a health product, be it a dietary supplement sold in the United States (U.S.) or a Natural Health Product (NHP) marketed in Canada. This will be a key component of your dietary supplement and NHP marketing strategy. We know advertising health products is critical to your marketplace success and we want to help you make sure it is done the right way.

Firstly, it is important to note that while dietary supplements are equivalent to the NHP categories, there are some major differences in regulations between the two countries.

U.S. Canada
  • Only new dietary ingredients require pre-market notification to the Food and Drug Administration (FDA)
  • NHPs are subject to pre-market approval.
  • Dietary supplements are regulated post-market, as a subset of foods, and restricted to products taken by mouth (e.g., capsules, tablets, soft gels, gel caps, powders, bars, gummies, liquids, etc.)
  • NHPs are considered a subclass of drugs, and can be formulated in pharmaceutical-like dosage forms (e.g., elixir, suppository, topical ointment, etc.)

As a result, the potential claims for dietary supplements and NHPs vary significantly with most dietary supplements carrying structure/function claims and NHPs ranging from low- to high-risk health claims.

Given the complexity and nuances between jurisdictions, Nutrasource’s regulatory experts will help you understand how to approach claims substantiation and apply these best practices to both product types. 

 

Label Claims for Dietary Supplements – in US and Canada

  • A health claim (both U.S. & Canada): used to indicate the beneficial effect of a product in reducing the risk of a disease or health-related condition when used in accordance with its recommended conditions of use.
  • A structure/function claim (only for the U.S.): describes the role of a nutrient or dietary ingredient on the normal structure or function of the human body.

In the U.S., dietary supplements may make health claims; however, they are subject to pre-market review and authorization by the U.S. FDA. Structure/function claims are not pre-approved per se, but a notification must be submitted to the FDA no later than 30 days after the dietary supplement is first marketed.

In Canada, an NHP must have a recommended use expressed via its health claim, and that health claim must have a health context in order to attain Health Canada approval in the form of a Natural Product Number (NPN). Therefore, given the conditions under which NHPs are screened, reviewed, and subsequently approved, they cannot carry structure/function claims.

 

This flowchart summarizes the different categories of claims in the U.S. and Canada.

Claims flowchart

Constructed using guidance documents from the FDA and Health Canada.

 

Simply put, in order to avoid unnecessary and potentially costly consequences, we need to know the do’s and don’ts to consider when assessing a product’s claims potential.

 

Claims dos and donts (1)

 

Nutrasource offers claims substantiation consulting to ensure regulatory compliance for your product label in line with the various geographical jurisdictions.

Speak to a member of our team on how we can support your regulatory needs.

 

RELATED CONTENT

Related Content - for website pages (1)-1

 


Read More

Tags: Claims, Regulatory, Dietary Supplements/Natural Health Products, market access

FDA Announces New Policy for New Dietary Ingredient Notifications (NDINS) - An Ingredient Manufacturer Must Read!

Posted by Nutrasource on Wed, Jun 29, 2022

Summary: FDA announces draft guidance for industry on their policy to exercise enforcement discretion on delinquent notifications to encourage firms to submit NDIN to correct past failures. Read on to learn more.

Read More

Tags: Product Testing & Certifications, Regulatory, Concept to Claim, ingredients, market access