Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice. We are thinking of all of you in these difficult times, and hope all of you and your loved ones are safe.
Industry Insights
A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada
By: Seth S. Ray
On September 25, 2020, the Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule allows FDA-authorized programs to import certain prescription drugs from Canada under specified conditions designed to ensure that the imported drugs pose no additional risk to the public’s health and safety, as well as to provide a “significant reduction” in costs to American consumers. The final rule goes into effect on November 30, 2020. More >
We Have Come Full Circle: FDA Will No Longer Authorize Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
By: Carolina M. Wirth
On October 15, 2020, FDA reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) manufactured in China that are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). Effective immediately, for emergency use, FDA will authorize only those respirators currently listed in the EUA’s Appendix A (List of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China). The agency will continue to allow the emergency use of the respirator models that have already been added to Appendix A, in order to mitigate any current shortages of FFRs. However, the agency also stated that it would no longer “review requests nor add to the list of authorized respirators . . . .” More >
Required Revisions to Nutrition and Supplement Facts Labels are to be Fully Implemented by January 1, 2021
By: Robert Durkin
The Food and Drug Administration issued new regulations requiring changes to the nutrition and supplements facts labels of conventional food and dietary supplements, respectively, on May 27, 2016. Eventually, implementation dates for these new regulations were set so that manufacturers with $10 million or more in annual sales were required to switch to the new label by January 1, 2020, and manufacturers with less than $10 million in annual food sales have until January 1, 2021, to comply. FDA also announced that it intended to exercise enforcement discretion to “work cooperatively with manufacturers and will not focus on enforcement actions during 2020 for larger manufacturers and during 2021 for smaller manufacturers.” More >
