FDA warning letter puts nicotine gum maker in a tough spot - MedCity News

The FDA regularly sends warning letters noting any violations. Problems found in drug manufacturing facilities are common reasons for these regulatory notices. So are marketing violations. This past week has been marked first warning letter. The agency sent one for chewing gum.

The letter was sent to VPR Brands, which does business under the name Krave Nic. The company produces nicotine gums with different flavors that are designed for adults who smoke. The FDA’s concern is that these products resemble candy and pose a risk of nicotine toxicity to children. Each gum contains 1 mg of nicotine. According to the FDA, research shows that ingesting 1 to 4 mg of nicotine can be toxic to children younger than 6, depending on body weight. The FDA also notes the addictive effect nicotine can have on the young and developing brain.

Krave Nic describes its gums as tobacco-free products that “give adult smokers the tools to use nicotine on their own terms.” But on letter from the FDA tells the company that a “tobacco product” as defined by law must not contain tobacco. The letter explains that President Biden signed legislation in March amending the Food, Drug, and Cosmetic Act to expand the FDA’s jurisdiction over products that contain nicotine from any source.

Krave Nic has 15 business days from the August 18 letter to submit a written response explaining how it intends to comply with the law. The company has already taken at least one step. It is website now it says its product is discontinued.

Here’s a roundup of other regulatory developments from the past week:

— The oncopeptide drug Pepaxti won Approval by the European Commission for the treatment of relapsed multiple myeloma. The FDA approved the peptide drug early last year, and it was briefly available in the US under the name Pepaxto. Last summer, the FDA issued alarm warning that a clinical trial has found an increased risk of death associated with the drug. Stockholm-based Oncopeptides initially notified the US agency that it would voluntarily withdraw the drug, then later rescinded that letter. In March, Oncopeptides said it would stop marketing the drug in the US until “a mutual understanding is reached on how to interpret the data with the FDA.”

— A Cara Therapeutics drug that treats the severe itching called pruritus associated with chronic kidney disease was approved in Switzerland, where it will be sold under the name Kapruvia. The peptide drug won FDA approval last year and marketed in the US under the name Korsuva. Stamford, Connecticut-based Cara said it expects regulatory decisions on the drug in Australia and Singapore by the end of this year.

— Bayer’s contraceptive Mirena, an intrauterine device (IUD), has won FDA approval for expansion the use of the long-acting product from seven years to eight years. The product’s regulatory nod in 2000 made it the first hormonal IUD approved for use in the US

— Hearing aids are about to become much more affordable for consumers. FDA finalize a new rule which creates a new category of over-the-counter hearing aids for people with mild to moderate hearing loss. Hearing experts told MedCity News that the regulatory move will expand patient access to hearing care.

— Beta thalassemia, currently treated with regular blood transfusions, now has an FDA-approved gene therapy designed to be a one-time treatment. Following FDA approval for therapy called Zynteglo sets Summerville, Mass.-based Bluebird Bio at $2.8 million. But the biotech also unveiled an outcome-based reimbursement strategy that says it will refund up to 80 percent of the drug’s cost if patients don’t achieve transfusion independence.

— FDA lifted a partial clinical hold placed on a lymphoma study testing the drug Curis emavusertib. But a partial hold on a test of the same drug in leukemia is still in place. Both holds were placed after the death of a patient in the leukemia study. Curis said it has a strategy for monitoring and managing a potentially fatal side effect associated with its drug.

— The millions of patients suffering from depression have a new FDA-approved treatment that is designed to work faster. Many currently available depression medications can take six weeks or more to start working. Axsome Therapeutics’ already approved drug, Auvelity, starts working within a week.

Public domain image by Flickr user Jonathan Cutter

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