Public health advocates and vapers can breathe a sigh of relief as the FDA has just announced a comprehensive new plan for tobacco and nicotine regulation, which will delay the PMTA (PreMarket Tobacco Applications) deadline until 2022.
“We must recognize the potential for innovation to create less harmful products under FDA oversight. While there is still much research to be done on these products and the harms they may cause, they do have certain benefits that we should consider. Investing in FDA’s regulatory science can certainly answer those questions about benefits and harms,” newly appointed FDA Commissioner Scott Gottlieb said at a press conference.
Get a practical look at nicotine
The PMTA deferral is part of an anti-tobacco plan that includes removing nicotine from regular cigarettes, expected to begin in 2021.
“Nicotine is not necessarily a safe and benign substance. But a public-health approach to reducing tobacco-related disease must start with the premise that, as far as nicotine is concerned, the problem is not just nicotine. The biggest problem is the way nicotine is delivered. Attach it to the smoke that comes from cigarettes, and that is a dangerous way of delivering it,” Mr. Gottlieb said.
“But when nicotine is attached to medical products that do not contain the harmful chemicals found in tobacco, these therapeutic products have been shown by the FDA to be safe and effective for smokers. In fact, with nicotine replacement products such as gum, capsules, and patches, the FDA does not even require a prescription,” the FDA commissioner added, pointing out that nicotine can be delivered in safe ways.
The agency will issue guidance detailing the policy, and the deadline for submitting applications for END or e-cigarette products is expected to be postponed to August 2022. On a separate note, the newly strengthened policy will not affect requirements for tobacco and smokeless tobacco products, but only for regulated products other than cigars and e-cigarettes . Additionally, the plan will not apply to laws already in place, such as age restrictions and ID checks at the point of sale.
A victory for public health
“To complement these broader policies, the FDA intends to publish baseline rules that will make the product registration process more efficient, predictable, and transparent for manufacturers, while maintaining the agency’s proper accountability,” said one of the final paragraphs of the FDA press conference. Many people will feel better after hearing these assurances. The FDA has softened its stance on e-cigarettes, and the agency itself has begun to open up to safer alternatives.
Source: Diane Caruana - Vapingpost
Translator: The Vape Club
