The draft guidance, entitled "Guidance for industry: evidence-based review system for the scientific evaluation of health claims", is open for comment.
The purpose of the document, according to the federal agency, is to set out FDA's current thinking on the process for evaluating scientific evidence for a health claim and credible scientific evidence to support a qualified health claim.
"Because of the similarity between the scientific reviews for SSA and qualified health claims, FDA intends to generally use the approach set out in this draft guidance for evaluating the scientific evidence in petitions that are submitted for an SSA health claim or qualified health claim," states the draft guidance.
The Nutrition Labeling and Education Act (NLEA), which forms part of the Federal Food, Drug, and Cosmetic Act, made labeling of packaged foods compulsory in 1993 and paved the way for label claims that relating certain foods to disease risk reduction.
"The draft guidance, when finalized, will represent the agency's current thinking on the scientific review process for SSA and qualified health claims," stated the agency. "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."
The FDA recently issued another draft guidance, this time for the Complementary and Alternative Medicine industry, which generate much confusion as parties were uncertain as to whether the document pertained to them or not.
Following the misunderstanding, the federal agency extended the comment period for the document and underscored that the CAM guidance is meant to be a point of reference and neither contains nor proposes and any regulatory changes for any CAM products marketed in the US.
