Members Heads-Up on Two New Hot FDA Announcements

By Mark Land, AAHP President

Recently members received a special e-blast alerting them of two important FDA announcements. While members can read more on a password protected webpage as a member benefit, it is worth briefly summarizing the announcements for all our readers to keep our industry compliant.

First, FDA distributed a public service announcement aimed at consumers for the upcoming cough and cold season. In this Oct. 28, 2021 announcement, FDA re-affirmed its position: that most children will recover from cough and cold symptoms on their own. This is similar to the agency’s 2008 announcement that cautioned parents against giving these types of allopathic medications to children, especially under the age of two.

However, unlike in 2008, the agency latest announcement includes homeopathic cough and cold medicines. Among other text, it states: “There are no FDA-approved homeopathic products, and homeopathic products sold in the U.S. have not met the FDA’s requirements for safety and effectiveness. The FDA is not aware of any proven benefits of these products and urges you not to give homeopathic cough and cold medicine to children younger than 4.”

Second, FDA announced a new requirement (stemming from the CARES Act) for reporting annual manufacturing data by all drug manufacturers. The Oct. 29, 2021 draft guidance is entitled, “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act”. Feb. 15, 2022 is the first deadline to meet for the 2020 year, followed by a May 16, 2022 deadline for the 2021 year.

The AAHP Board is planning two informational sessions to help members further delve into the ramifications (and implementation of the Annual Reporting requirement) in the coming weeks. Details of these two sessions are being finalized; watch your email for notice of the day and time of each, and be sure to sign up to get the most complete information available to AAHP.