Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale?

If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and Drug Administration (FDA) expanded authority to regulate dietary supplements?

“Gas station heroin” is a

Marc Ullman recently authored “The Problem Isn’t DSHEA — It’s FDA Siloing” in Natural Products Insider.

In the article, Marc explains the dangers of the silo effect and how it limits interactions between members of different branches of the FDA. This results in reduced productivity and the issuing of only single-center warning letters on noncompliant

Marc S. Ullman, of counsel to Rivkin Radler, recently authored “FDA sends a message with two warning letters to Amazon” in Natural Products Insider.

In the article, Marc explains the importance of the FDA warning letters on homeopathic “supplements” and products that contain active pharmaceutical ingredients. Ullman writes, “During the last quarter of 2023,

Steven Shapiro and Marc Ullman wrote the article, “What Dietary Supplement Companies Can Do to Address Potential Counterfeiting of Their Products,” for the August 2023 issue of Nutrition Industry Executive.

The article explains how counterfeit products are going mainstream by moving to legitimate websites. It details how two dietary supplement companies determined that a fraudsters were

In its August 2023 issue, Vitamin Retailer published Marc Ullman’s article, “Counterfeiting Headaches Aren’t Just for High Fashion Retailers and Designers Anymore.”

The article explains how counterfeiters have entered the dietary supplements market and how their products have been able to proliferate. It also offers some advice on how consumers and retailers alike can protect themselves

Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321(i), “cosmetics” are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance

The FDA is facing possible legal action after three citizen petitions were rejected by the administration. All petitions were requesting that the FDA allow for the inclusion of CBD in dietary supplements, through some trade groups.

Ullman

Jeff Kaiser’s article, “DOJ Issues New Guidance on Criminal Enforcement,” appeared in the winter 2023 issue of USLAW Magazine.

Click here to read the article.

OMIG UPDATE: COMPLIANCE, SELF-DISCLOSURE, AND MANAGED CARE FRAUD, WASTE, AND ABUSE GUIDANCE POSTED

On the heels of publishing their final regulations, on January 31st, the Office of the Medicaid Inspector General (OMIG) released a variety of guidance documents addressing compliance programs; self-disclosure; and Medicaid managed care fraud, waste and abuse prevention programs. The guidance documents

Marc Ullman was published in Natural Products Insider. His article, “Analysis: CBD food industry unlikely to placate FDA,” discusses the potentially negative impact on the FDA’s interpretation of the exclusionary clause in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Ullman fears the current interpretation of the act will have a long lasting