FDA bans Red Dye No. 3; doctor sentenced for $70 million Medicare fraud scheme; last call for proposals for the 2025 CMS Health Equity Conference – Morning Medical Update

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FDA bans FD&C Red No. 3

The U.S. Food and Drug Administration (FDA) issued an order to revoke the authorization for the use of FD&C Red No. 3 (also referred to as Red Dye No. 3, Red Dye 3 and erythrosine) in food and ingested drugs, based on the Delaney Clause of the Federal Food, Drug and Cosmetic Act (FD&C Act), which prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. Manufacturers who use FD&C Red No.3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products.

Among other data and information, the FDA has cited two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3. The cancer was caused by a rat specific hormonal mechanism, which does not occur in humans. FD&C Red No. 3 is mostly seen in food products, including candies, cakes, cupcakes, cookies, frozen desserts and frostings and icings, as well as certain ingested drugs, according to the FDA.

Doctor sentenced for $70 million Medicare fraud scheme

David M. Young, MD, 61, of Fredericksburg, Texas, was sentenced to 10 years in prison and ordered to pay $26,622,522.82 in restitution for his role in a scheme to defraud Medicare by prescribing orthotic braces and cancer genetic testing, which he falsely represented as medically necessary, without ever seeing, speaking to or otherwise treating patients. In total, he prescribed braces and genetic tests for more than 13,000 Medicare beneficiaries, including undercover agents posing as beneficiaries. His prescriptions were used by brace supply companies and laboratories to bill Medicare more than $70 million. Young was paid roughly $475,000 for his role in the scheme.

Last call for proposals for the 2025 CMS Health Equity Conference

The Centers for Medicare & Medicaid Services (CMS) will host the 2025 CMS Health Equity Conference on April 23-24, 2025, in Bethesda, Maryland, and virtually. CMS is accepting proposals for breakout session speakers and poster presenters until January 21, 2025, at 5 p.m. PT. They are accepting proposals for lightning talks (7 minutes each), single presentations (15 minutes each with joint Q&A) and poster sessions. CMS hosted a “call for proposals webinar” earlier this week to discuss proposal guidelines for this year’s event, for which the theme is Building a Healthier America. Additional information on submitting a proposal can be found here.