Sunday , August 7 2022

FDA offers new regulations on the US News


(CNN) – The Food and Drug Administration of the United States offers new controls on the oversight screens in an attempt to keep up with the latest scientific and security information.

The offer, published on Thursday, is available for public review and comments for the next 90 days and addresses the security of common sunscreen ingredients, as well as & # 39 ; d forms, sun protection factor (SPF) and broad spectrum requirements. It is also going to label it, aiming to make it easier for users to identify information about key products.

"Since the initial evaluation of these products, we know a lot more about the effects of the sun and for the absorption of the skin through the skin," says Commissioner FDA, Dr. Scott Gottlieb, in a statement.

Sun-sulled sunscreen products are regulated by the FDA under the Sunscreen Innovation Act, a fast process has to be implemented in 2014. Some ingredients can be marketed without going through the application process New drugs because they are generally considered safe.

Keep using sunscreen, experts advise

The proposed regulation would allow some ingredients and formulations to continue to be marketed without new drug approvals, including zinc oxide, titanium oxide and sunscreens sold as sprays, oils, lotions, creams, gels, gestures, pies , nappies and sticks.

Two ingredients – PABA and salicylate trolamine – on the list of recognized ingredients would not normally be safe and effective, and that any product that included these would be considered a new drug and would; It must be approved by the FDA before it is marketed.

For another 12 ingredient list, the agency said that there is not enough data to determine appropriate security and regulation; as such, he has asked the sunshine industry to carry out additional tests.

The agency has also asked the industry to have additional tests on powders and indicated that wibers, towellettes, washing body, shampoos and other dose forms would be considered new drugs and had to go through & # 39 ; r approval process.

The ingredients required by the FDA for additional security data have been around and used in the United States for at least 20 years, said Dr. Henry Lim, former president of the American Dermatology Academy and a dermatologist at Henry Ford Hospital in Detroit. He said that he approves the FDA's efforts to collect additional security data for some of them, but it does not want people to put the best on sunscreen over security concerns.

"We're pretty comfortable with the types of sunscreens we have in the United States at the moment," he said.

Lim also worries that the proposed regulation would make it difficult for sunscreen ingredients to be available in other parts of the world to be approved in the United States, as companies can not be willing to carry out the required tests.

Environmental advocates praised the motion.

"Over a decade, EWG has worked to raise sunscreen concerns with oxybenzone," said David Andrews, senior scientist in the Environmental Working Group, unprofitable environmental advocacy. "Today, the FDA acknowledged those concerns and said that oxybenzone and 13 other ingredients are not safe and effective to use."

SPF value and protection spectrum

The offer also addresses SPF screens and broad spectrum broadcasts.

It would increase the maximum SPF labeling on products from 50 to 60, based on new evidence of some clinical benefits of additional SPF.

The regulation would also require each product to be labeled with a SPF of 15 or more to offer a wide spectrum protection against UVA rays, usually associated with premature skin aging, and UVB rays, and # 39; n associated with skin cancers and sunburn.

The American Dermatology Academy recommends rising water-resistant products, with the protection of broad spectrum and SPF at least 30.

Product labeling

The proposed regulation would also require manufacturers of the sun to clearly label their products with active active ingredients, as well as more clear formats for SPF statements, broad spectrum and water resistance.

Sunscreens currently produced with insect rehabilitation would also be considered new drugs.

The FDA seeks comments from the public. "We will continue to work with industry, consumers and public health stakeholders to ensure we strike the right balance," said Gottlieb.

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