Drugs

Evolved Ayurvedic Discoveries Selling Unapproved CBD Products: FDA

An FDA 2020 review of the Web site and Facebook and Instagram pages maintained by Evolved Ayurvedic Discoveries, Encinitas, CA, determined that the company takes orders for several BioCBD+ products that claim to contain cannabidiol. A 2/11 Warning Letter says the Web site offers products that are intended to mitigate, prevent, diagnose, treat, or cure Covid-19 in people. The letter says the company’s products are unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act.

Also, FDA says, the company’s BioCBD+ Peace Vape product is particularly concerning because the ingredients and potential impurities in oral inhalation products may trigger laryngospasm and bronchospasm and may be toxic to tissues in the upper or lower airways.

Although one of the products is labeled as a dietary supplement, FDA says, it does not meet the legal definition of a dietary supplement.

The letter says the firm’s BioCBD+ products are misbranded because their labeling doesn’t contain adequate directions for use and it is not possible for such directions to be written so that a layperson could use the drugs safely for their intended use.

Evolved 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, with documentation of each step and a timetable for completing the steps.

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