Foreign sunscreen packaging new ideas

Fifty years ago, the sunscreen industry began to develop. In 1966, consumers demanded protection against UVB radiation. Dark brown skin color represents health, with a vibrant, younger brilliance. Nowadays, the incidence of skin cancer is getting higher and higher. There are more than 2 million new cases in the United States every year. The death caused by melanoma is also increasing year by year. The efficacy of sunscreen products has been questioned. Only 3% of women think that they are dark brown. The skin is attractive. Every day, you can see a wide range of verbal, fierce, controversial reports, articles, and blogs, and vigorously criticize the efficacy and safety of American sunscreens.

The most shocking of all sorts of recent speeches heard by the U.S. Congressional staff was Dr. Theresa Michele, the director of the Nonprescription Drugs Division (DNAP). She believes that not everyone will suffer from skin cancer due to sun exposure. Sunscreen is the culprit!

Michele is responsible for the regulation of sunscreens at the FDA, and if her point of view is correct, this is a reflection of the attitude and attitude toward new and improved sunscreen ingredients and regulations. This is indeed shocking!

The United States Environment Working Group (EWG) released its tenth annual report in May. With the title “Never the last resort, don't use sunscreens”, the sunscreen products on the market were evaluated with very strict restrictions. Only a few were standard. The EWG pointed out that all sunscreens sold in the mass market, that is, products used by more than 80% of consumers in the United States, are ineffective and should be avoided. Any sunscreen containing oxybenzone (benzophenone-3) or retinyl palmitate (vitamin A), or an SPF value higher than 50, was rated low or deemed unsafe. This standard focuses on the use of inorganic particles (non-nanoparticles) and avoids any potent chemical UV absorbers.

At the same time, the Consumer Reports released a rigorously rigorous test report on sunscreen products in the United States called "What questions and answers you need to solve." After testing 65 sunscreens, sunscreens, and sunscreen sticks, the Consumer Reports editor found that nearly half of the products had SPF values ​​much lower than the SPF values ​​on the labels. A product labeled SPF 50, the test value is only 8! It should be noted, however, that the Consumer Reports do not use the SPF test method approved in the FDA Monograph.

A new study was published online by the Journal of the American Medical Association - Dermatology. Researchers at Northwestern University School of Medicine in Chicago analyzed 65 sunscreens (1% of the 6,500 sunscreens on the market). As a result, it was found that 40% of the highest grade sunscreens did not meet the requirements of the AAD (American Academy of Dermatology). The main reason was that these products were not really waterproof and sweat-proof. The researchers also warned about the abuse of some slogans, such as "safe for sensitive skin," "preservative-free," or "without acne."

The negative remarks made by social media are also fueled by oil, and it is even more difficult for consumers who seek to prevent sun-damaged radiation products from clarifying their clues. In the past few months, there have been some aggressive headlines, such as "How can the sunscreen fail to fulfill its promise, how to deal with it?", "Please forgive me for smearing these poisonous creams for children", "The sunscreen is destroyed. Coral reefs, sunscreen damage the function of sperm cells, etc. These frustrating articles, coupled with the FDA's “Component Evaluation Guide” report on sunscreen ingredients “does not meet standards”, it is not surprising that the US sunscreen products will face such a crisis.

responsibility

The FDA has given up its responsibility for the approval of proven and effective sunscreen ingredients in Europe and other parts of the world. On June 29th, in an event of the "White House Cancer Exploratory Special Team", the US Vice President Joe?

Biden pointed out: "What I would like to add is that in a period that is not very exact but at least nearly two decades, there has been no substantial progress in the application of sunscreens and new sunscreens. This is a very long time."

Consumers themselves also have to take responsibility. They do not comply with the suggestion of avoiding the hot sun exposure between 11am and 4pm. They do not wear protective clothing and frequent the sunbathing salon. More importantly, they are not adequately applied. Amount of sunscreen. A recent report in the Journal of the American Medical Association pointed out that only 14.3% of men regularly use sunscreens, and there are numerous reports that ordinary consumers use sunscreens before they are exposed to sunlight. Sunscreen manufacturers also have responsibilities. They have not invested in basic research to obtain quality sunscreen active ingredients, have not studied the underlying causes of skin cancer, and have not actively proposed good protection options. There is no doubt that the layers set by the regulators have cut down the impetus for expensive research. But to reduce this alarming skin cancer statistics worldwide, we must invest a great deal of effort.

In response to the FDA's response to the Sunscreen Innovation Act promulgated on November 26, 2014, there is one final point to make. On May 23, 2016, the FDA submitted to Congress a report signed by Dr. Robert Califf, the new director, covering a period of 18 months (November 26, 2014 to May 11, 2016). In this selection section of the report's conclusions:

“Conclusion: The FDA has fulfilled all statutory responsibilities under the Sunscreen Innovation Act so far. The FDA is responsible for providing US consumers with more safe and effective sunscreen active ingredients. The FDA meets with the supplier in a timely manner. Investigate data requirements for sunscreens and provide draft guidelines for assisting suppliers.FDA relies on the industry to submit the necessary additional data as support to determine that a sunscreen containing a given active ingredient is 'generally considered safe and effective'. ”

The only thing that needs to be pointed out is that since August 2002 (14 years ago), none of the “Time and Scope Applications (TEA)” UV filters have been approved in the United States. In fact, since 1978 (38 years ago), only two UV filters—Avobenzone and Zinc Oxide—have been approved in the United States. Although sunscreen is not the only way to protect skin and it is not the only solution to reduce the incidence of skin cancer worldwide, in the current formula of sunscreen in the United States, there is no high quality UVA.

In the field of protection, sun protection products acquired by new, leading basic research institutes are included.

Good news

Let us look at the other side again. Solar radiation (including ultraviolet light and infrared light) is an environmental carcinogen and the human body can cause melanoma and non-melanoma skin cancer. It is estimated that 2.2 million of the approximately 3.5 million patients in the United States are diagnosed with cancer. It has been reported that 95% of ultraviolet radiation reaching keratinocytes and melanocytes belongs to UVA radiation. Therefore, providing special protective measures against UVA radiation is the key to prevent melanoma and non-melanoma skin cancer.

Unfortunately, UVA filters also need substantial improvements, especially in the United States. The two inorganic filters ZnO and TiO2 can provide some protection against UVA, but cosmetics usually do not use them as formulations, they are more easily degraded than traditional chemical absorption filters. There are two types of absorption filters approved in the United States, namely oxybenzone and avobenzone. The former is related to hormone interference, the latter has light stability problems and requires other filters and special formulation techniques for quenching. In contrast, many other effective UVA filters have been used in other parts of the world and have been used for more than a decade.

Some groups in the industry have joined forces to establish a "safety sunscreen public alliance" to persuade Congress to resolve the lack of adequate sunscreen protection for US consumers. In November 2014, the U.S. Congress unanimously passed the Sunscreen Innovation Act, signed by President Barack Obama and effective immediately. The Sunscreen Innovation Act requires FDA to review the pending “time and scope applications” that have been in place for more than a decade, and to determine the safety and efficacy of these sunscreen active ingredients within 300 days. Unfortunately, the FDA then rejected all eight applications awaiting review and requested extensive additional safety data, including systemic carcinogenicity studies, systemic reproductive and developmental toxicity studies, and animal toxicokinetics - both in re-use and After the study of local human safety. In addition, the FDA recommends using the human pharmacokinetic data at the time of maximum use to assess the dermal permeability of UV filters to make a "generally considered safe and effective" judgment. These new tests are called "maximum use tests (MUsT)".

In view of the current situation, the public association of safety sunscreens commissioned Edward Sargent (Rogues University) and Jeffrey Travers (Wright State University) to conduct a study, and published in 2015 "Control of Toxicology and Pharmacology." The report recommends the development of a non-clinical safety test code for sunscreens to test the safety of UV filters and introduce new sunscreens to the US market.

Subsequently, the public safety sunscreen group requested a meeting with the FDA to discuss the proposal. The FDA is currently planning to finalize the schedule of a public forum as soon as possible to assess the MUsT testing program and other related issues of the sun protection program. If the proposed open meeting is held, it will be a positive development in the sun protection industry!

Several recent studies on sunscreen protection have also made new progress. For example, Green and colleagues in Australia have confirmed that the use of broad-spectrum sunscreens and long-term monitoring can effectively prevent melanoma. In addition, Ghiasvand and colleagues from the University of Oslo, Norway, published a paper in the Journal of Clinical Oncology confirming the use of sunscreens with SPF 15 or more, and a large proportion of Norwegian women between 40 and 75 years of age (143,844). ) There is a correlation between approximately 30% reduction in the risk of melanoma.

At the same time, researchers at the University of Bath in the United Kingdom developed a chemical “mitoiron claw” that claims to provide unprecedented protection against harmful UV radiation. It protects mitochondria in the mitochondria, and the concentration of iron ions is very high. The researchers treated the human skin cells with sunlight equivalent to 140 minutes at sea level. The cells treated with mitoiron claw were protected and the untreated cells did not survive. Obviously, this is a major development, but given the current FDA backlog, it may take many years or even decades before new filters are used for sunscreens.

Under the current FDA supervision, it is difficult to make significant progress in the field of sun protection and light protection. The FDA stipulates sunscreens as drugs, while most other countries stipulate it as cosmetics. This insurmountable barrier has prevented better sun protection programs from entering the market. Therefore, the sensible approach is to adopt various sun protection methods, such as avoiding sunshine as much as possible between 10 am and 3 pm, and in accordance with some common methods, such as using a sufficient amount of SPF 30 or higher before exposure to sunlight. Broad-spectrum sunscreen, re-used once every two hours, wear appropriate clothing, bring umbrellas and hats. Regular inspections in dermatology are also highly recommended to reduce the complications caused by excessive sunlight.