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FDA approves genetically engineered Atlantic salmon as safe and effective for human food and releases related draft guidance on voluntary labeling
  • Kelley Drye & Warren LLP
  • USA
  • November 24 2015

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of


New FDA Guidance doubles-down on 1980 fortification policy and potential misbranding risks of “inappropriate fortification”
  • Kelley Drye & Warren LLP
  • USA
  • November 20 2015

FDA recently released its Guidance for Industry: Questions and Answers on FDA's Fortification Policy (Guidance) to "clarify the existing policy" in


FDA partially stays controversial policy of requiring INDs for clinical studies evaluating food, dietary supplements and cosmetics
  • Kelley Drye & Warren LLP
  • USA
  • November 10 2015

On Friday, October 30, 2015, FDA issued a Federal Register Notice announcing a partial stay of the agency's controversial Final IND Guidance entitled


FTC staff comment encourages FDA to reevaluate its current approach to regulating homeopathic products
  • Kelley Drye & Warren LLP
  • USA
  • August 24 2015

On Friday, staff of the Federal Trade Commission's Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a


FDA releases draft guidance on Voluntary Qualified Importer Program
  • Kelley Drye & Warren LLP
  • USA
  • June 9 2015

The FDA announced last week the release of a draft guidance that outlines FDA's plan to implement the Voluntary Qualified Importer Program (VQIP


FDA issues final rules prescribing broad labeling requirements for menus and vending machines
  • Kelley Drye & Warren LLP
  • USA
  • December 8 2014

The FDA recently released two long-awaited final rules that establish detailed requirements for calorie labeling on menus and menu boards and vending


Not so happy meals? New York City Council moves to ban free toys offered with certain food and beverage products
  • Kelley Drye & Warren LLP
  • USA
  • August 27 2014

The New York City Council introduced a bill last week that would prohibit restaurants from offering free toys or other giveaways aimed at children in


FDA issues long-awaited proposed “deeming” regulations for tobacco products
  • Kelley Drye & Warren LLP
  • USA
  • April 24 2014

The FDA today released a proposed rule that would "deem" certain products meeting the statutory definition of "tobacco product" to be subject to


FDA releases Draft Guidance on proper labeling of honey and honey products
  • Kelley Drye & Warren LLP
  • USA
  • April 8 2014

The FDA today released a Draft Guidance that offers a definition for "honey" without formally establishing a standard of identity and cites to


FDA reopens comment period on Final Guidance requiring INDs for certain food, dietary supplement, and cosmetic studies
  • Kelley Drye & Warren LLP
  • USA
  • February 6 2014

The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled "Investigational New Drug Applications