FDA regularly sends warning letters to flag various violations. Problems found in drug manufacturing facilities are a common trigger for these regulatory notices. The same goes for marketing violations.past week mark Write a warning letter first. The agency sent a message about fudge.
The letter was sent to VPR Brands, which does business as Krave Nic. The company makes nicotine gummies in a variety of flavors for adults who smoke. The FDA is concerned that these products resemble candy and may cause nicotine toxicity in children. Each gummy contains 1 mg of nicotine. According to the FDA, studies have shown that ingesting 1 to 4 mg of nicotine may be toxic to children under 6 years of age, depending on body weight. The FDA also noted that nicotine may have addictive effects on the young and developing brain.
Krave Nic describes its gummies as smoke-free products that “enable adult smokers to use tools to get their nicotine on their own terms.” But FDA letter Tell the company that a “tobacco product” as defined by law does not need to contain tobacco. The letter explains that President Biden signed legislation in March to amend the Food, Drug, and Cosmetic Act to expand the FDA’s jurisdiction to products containing nicotine of any origin.
Beginning with the August 18 letter, Krave Nic has 15 business days to send a written response explaining how it intends to comply with the law. The company has taken at least one step forward.its website Now it says its products have been discontinued.
Here are other regulatory developments over the past week:
——Oncopeptide drug Pepaxti wins European Commission Approval For the treatment of relapsed multiple myeloma. The FDA approved the peptide drug early last year and briefly marketed it in the U.S. under the name Pepaxto.Last summer, the FDA issued a alarm WARNING Clinical trials find increased risk of drug-related death. Stockholm-based Oncopeptides initially notified the U.S. agency that it would withdraw the drug voluntarily, and later withdrew the letter.In March, Oncopeptides said it would stop marketing Until “a mutual understanding is reached with the FDA on how to interpret the data.”
— A Cara Therapeutics drug used to treat severe itching (called pruritus) associated with chronic kidney disease is Approved in Switzerland, It will be sold under the name Kapruvia.peptide drug FDA-approved last year and launched in the U.S. under the name Korsuva. Stamford, Conn.-based Cara said it expects Australia and Singapore to make a regulatory decision on the drug by the end of the year.
— Bayer’s intrauterine device (IUD) contraceptive Mirena gets FDA approval expansion Long-acting products are used for seven to eight years. The product received regulatory approval in 2000, making it the first hormonal IUD approved for use in the United States
– Hearing aids will become more acceptable to consumers. U.S. Food and Drug Administration finalize new rules This creates a new category of over-the-counter hearing aids for people with mild to moderate hearing impairment. Hearing experts tell MedCity News Regulatory moves will expand patient access to hearing care.
— Beta thalassemia, currently treated with regular blood transfusions, now has an FDA-approved gene therapy intended as a one-time treatment. The following FDA approves therapy called Zynteglo, Somerville, Massachusetts-based Bluebird Bio sets price of $2.8 millionBut the biotech also unveiled an outcomes-based reimbursement strategy that would refund up to 80% of the cost of a drug if a patient can’t get a blood transfusion independently.
– FDA Lifting partial clinical hold on lymphoma study testing Curis drug emavusertibHowever, there are still partial reservations about testing the same drug in leukemia. In the leukemia study, both patients were put on hold after they died. Curis said it has a strategy to monitor and manage potentially fatal side effects associated with its drugs.
– Millions of people with depression New FDA-approved treatment aims to work faster. Many currently available depression medications can take six weeks or more to start working. The now-approved Axsome Therapeutics drug Auvelity started working within a week.
Public area Image via Flickr user Jonathan Cutler
