Fda dental health claim


FDA Dental Health Claim

Less than a decade ago, it was
actually illegal to make a disease-prevention claim for anything other than drugs, for
which FDA requires proof of both product safety and disease-specific efficacy. That law
has changed and FDA now allows for certain foods, if they meet very specific criteria
related to nutrient composition, “health (disease-prevention) claims” related to
heart disease, cancer, osteoporosis and birth defects.

Shortly after FDA approved its
first set of health claims, the agency was asked to review the scientific literature
related to dental caries and sugar replacers. Based on this review, a health claim based
on the association between sugar replacers and the non-promotion of dental caries was
finalized by FDA in August of 1996.

FDA’s criteria are very
specific
.

In order to use the non-promotion
of dental caries health claim, products must:

  1. contain one of the sugar replacers
    cited in the FDA regulation,
  2. meet FDA criteria for sugar-free
    status and
  3. when fermentable carbohydrates are
    present in the food, the food must not lower plaque pH below 5.7  by bacterial
    fermentation, either during consumption or up to 30 minutes after consumption as measured
    by the plaque pH-test specified in the FDA regulation.

Small packages of products that
meet these criteria may state:

“Does not promote tooth
decay”
or “May reduce the risk of tooth decay.”

Larger packages must also include
additional information, such as:

“Frequent eating of foods
high in sugars and starches as between-meal snacks can promote tooth decay.”

For more information, see McNutt
KM, Sugar Replacers and the FDA Noncariogenicity Claim, J. Dental Hygiene 2000;
74(1):36-40 

Click For “Details Of Cariogenity
Evaluation”
Click For
“Professional Journal References”

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