Claims are defined statements, symbols, or wording that are made on a product. They can be advertising, promotional, or any other content that details the product’s performance, usage, indication, application, or composition. The claims on product labels, promotional information, and marketing symbolize the correlation between consuming a food product and its supporting health advantages.

In most countries, there are individual laws and specific guidelines available to make claims on any food product, and these are required to have adequate scientific or clinical proof. The scientific requirements and corroboration can differ based on various aspects, such as the type of health claims, nutrient claims, functional claims, non-additional claims, or declarations, including sugar-free, gluten-free, etc.

In the United States, you must apply for FDA approval to get a health claim approved, and the FDA will review the application and supporting documents to back the claim on the product label.

The substantiation standard is a process in which health claims must be identified, implied, or defined based on the design, type of raw materials, product classification, regulations, and the studies available in scientific literature to validate the claims. Comprehensive data that support the product’s claims is crucial and can prevent loss of consumer confidence, legal fees, and damaged brand reputation.

The following are examples of possible claims that can be made:

  1. Low fat: the product has reduced levels of fat content
  2. Sugar-free: the product does not contain sugar
  3. No added sugars: a claim that sugars have not been added to food. If sugars are naturally occurring in the food, ‘contains naturally occurring sugars’ should appear on the label.
  4. High fiber: indicates that the food has high levels of fiber.
  5. Helps maintain cholesterol levels already within the normal range.
  6. Helps maintain proper joint function
  7. Use as part of your diet to maintain healthy blood sugar levels

As per the FDA regulations, the food labeling and nutrition regulations among the claims used on food labels, including dietary supplements, fall under three categories of claims. These are health claims, nutrient content claims, and structure/function claims. If you want a second opinion on your product’s label claims, EMMA International can help.  Quality and Regulatory experts can help assess your product’s claims to help remediate any issues. Contact EMMA International today at 248-987-4497 or email at info@emmainternational.com

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

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Abbreviated 510k submission

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Is your product a medical device?

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