FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Haloderm, Carlsbad, CA (10/6) FDA recently reviewed the firm’s Web site and determined that it takes orders for products that are unapproved new drugs. The letter says the products “are concerning from a public health perspective because they are labeled to contain the ingredients bloodroot and zinc chloride. Both substances are known corrosive agents. The combination of bloodroot and zinc chloride results in a corrosive agent capable of indiscriminately damaging healthy and diseased tissue alike and forming eschar (sloughed dead tissue).” The agency says it also has concerns about products marketed for removing moles. It says moles should be evaluated by a healthcare practitioner and that self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and even cancer progression. Haloderm was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence. To view the letter, click here.

Oneness Labs, Irvine, CA (10/6): FDA recently reviewed the company’s Web site (www.onenesslabs.com) and determined that it is marketing unapproved new drugs — “Oneness Labs Homeopathic Skin Tag & Mole Remover” and “Oneness Homeopathic Skin Tag & Mole Remover Extra Strength.” FDA says the products are worrisome because they are labeled to contain the ingredients bloodroot (Sanguinaria canadensis) and zinc chloride, which are known corrosive agents. The agency says the tissue necrosis caused by topical application of products containing such ingredients is well-documented. The letter tells Oneness to take prompt action to correct the cited violations. To view the letter, click here.

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