OTC Drug User Fees Halted – DHHS Withdraws FDA’s Notice
By: Jacqueline Chan Pausing the Over-the-Counter (OTC) Monograph User Fee Program, the Department of Health and Human Services (DHHS) has withdrawn FDA’s … more
Insights + News
New Fees to Usher in the New Year – FDA Announces Fees for OTC Drug Manufacturing Facilities and OTC Monograph Order Requests
By: Jacqueline J. Chan UPDATE (1/4/2021): The Department of Health and Human Services has withdrawn FDA’s Federal Register notice establishing the FY2021 … more
FDA Issues Five More Warning Letters to Marketers of CBD-Containing Products
By Stacy L. Ehrlich and Justine E. Lenehan It has been a tough week for cannabidiol (CBD) products. In a December 22 … more
FTC’s Operation CBDeceit – The FTC Brings Down the Hammer on Deceptively Marketed CBD-Containing Products
By Stacy Ehrlich and Justine E. Lenehan On December 17, 2020, the Federal Trade Commission (FTC) announced that it is taking legal … more
A Masterpiece by Any Other Name: State Hemp Laws
By: Daniel Dwyer and T. Daniel Logan As Shakespeare’s MacDuff said, in a slightly different context, “Confusion now hath made his masterpiece!” … more
Assuring Quality or Ensuring Control? What the finalization of Good Guidance Practices by the Department of Health and Human Services could mean for the Food and Drug Administration
By: T. Daniel Logan On December 7, 2020, the Department of Health and Human Services (HHS) published a rulemaking that formally adopts … more
KKB Partner Stacy Ehrlich to Speak on Current Enforcement Issues for Tobacco Products at FDLI Conference
KKB Partner Stacy Ehrlich will be presenting and moderating a panel entitled “The Premarket Tobacco Product Application Deadline Has Passed – What is the … more
KKB Partner Will Woodlee to Discuss National Bioengineered Food Disclosure Standard at Food & Beverage Industry Conference
KKB Partner Will Woodlee will be participating in a panel on December 1, 2020, at the 2nd Annual Food Label Claims: Risk … more
TTB Issues Updated Ruling on “Gluten-Free” Labeling for Alcoholic Beverages
By: T. Daniel Logan On October 13, 2020, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an updated ruling entitled … more
Got Sesame? FDA Issues Draft Guidance Encouraging Food Manufacturers to Clearly Declare Sesame on Food Labels While Considering Potential Controls for Emerging Food Allergens
By: Jacqueline J. Chan In November 2020, FDA issued a draft guidance, Voluntary Disclosure of Sesame as an Allergen, which strongly encourages … more