FDA Policy/General

FDA Signals Plan to Ease Supplement-Label Disclaimers

FDA is weighing changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion as it evaluates industry requests to do so, the agency said in a 12/11 letter to industry.

At issue is a requirement in 21 CFR 101.93(d) that mandates the Dietary Supplement Health and Education Act of 1994 (DSHEA)-mandated disclaimer — “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”—appears on each panel of a supplement label that includes a structure/function claim. Those statements, known as 403(r)(6) claims, are permitted under DSHEA when accompanied by the disclaimer.

Deputy Commissioner for Human Foods Kyle Diamantas wrote that FDA has received multiple petitions to revise the placement requirement, and the agency’s preliminary review suggests that eliminating the “each panel” mandate would be consistent with DSHEA while reducing label clutter and compliance costs. He also acknowledged that FDA has “rarely, if ever” enforced the rule as written.

If the agency identifies no significant concerns during its ongoing review, it expects to move forward with a proposed rule to amend the regulation.

Because rulemaking can be lengthy, FDA said it will exercise enforcement discretion in the meantime. Specifically, the agency does not intend to enforce the requirement that the DSHEA disclaimer appear on every panel containing a 403(r)(6) claim. However, firms must still include the disclaimer on the product label and must continue linking it — by adjacency or with an asterisk — to each structure/function claim, along with meeting all other requirements in 21 CFR 101.93.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome