Health Claim Substantiation Pop Quiz! – Understanding the Regulatory Requirements for Making Health Claims

September 29, 2014 4:00pm

  • What are the different types of beverage product claims?
  • What are the regulatory requirements for making each type of claim?
  • When can information provided on a food product label be classified as “optional information”?
  • Under what circumstances a health claim that has been cleared through FDA’s pre-market clearance procedures can be deemed
    • unauthorized under the FDCA?
    • an unapproved new drug specifically in the context of disease prevention claims?
  • What type and quantity of evidence is sufficient to meet FDA and FTC expectations for product claims?