Beauty Tips For Body Care
The next-gen chemical (organic) filters mentioned in the title are the best UVB and UVA blockers in the world. They are also known by their various chemical names:Mexoryl SX (aka Ecamsule): Terephthalylidene Dicamphor Sulfonic AcidMexoryl XL: Drometrizole TrisiloxaneTinosorb S (aka Bemotrizinol): Bis-Ethylhexyloxyphenol Methoxyphenyl TriazineTinosorb M (aka Bisoctrizole): Methylene Bis-Benzotriazolyl TetramethylbutylphenolTinosorb A2B: Tris-Biphenyl TriazineUvinul A Plus: Diethylamino Hydroxybenzoyl Hexyl BenzoateUvinul T 150: Ethylhexyl TriazoneNone of the aforementioned sunscreening agents have been approved for use by the FDA, despite them having a presence in European and Asian sunscreen formulations for almost three decades (and Europeans and Asians aren't dropping dead from slapping their vastly superior sunscreens on).The Hawaii ban enacted on Oxybenzone and Octinoxate will inevitably see these filters being phased out from the U.S. market in the years to come. If the FDA does not approve the aforementioned filters by then, American sunscreen manufacturers will be left with very little material to work with. Oxybenzone is one of just two chemical filters approved by the FDA that screen out UVA. The last one left standing will be Avobenzone. Octinoxate is also a popular UVB filter. If it goes, consumers will have to put up with increased amounts of Homosalate and Octocrylene, which are old ass filters that have a controversial safety record.The Hawaii sunscreen act has shone a spotlight on the FDA's stubborn refusal to approve new filters. American consumers desperately need access to next-gen UV filters to protect themselves from skin cancer and ensure the general health of their skin. Melanoma rates are on the rise and the number of sunscreen filters recognised as GRASE (generally regarded as safe and effective) in the US is dwindling... more skin cancer + a sunscreen drought is NOT a good combination. So why is the FDA dragging its feet in this critical time?The FDA claims that "...it doesn't have enough scientific information on the effects of the pending molecules when absorbed into the skin to officially recognize them as safe and effective." Source 1Fine, so if the FDA is skeptical, the onus is on the manufacturers to use their seemingly endless stores of money to run studies and submit documentation, right? L'Oreal, which owns the patent to Mexoryl XL and SX, could easily drop a few million $ to run the studies, prove Mexoryl's safety profile to the FDA, and get the approval it needs. As a matter of fact, the company appears to have worked with the FDA back in 2005 to get Mexoryl approved. Source 2BASF, the German manufacturer of Tinosorbs and Uvinuls, offered the FDA 15 - FIFTEEN - years of data on the safety profile of Tinosorb and Uvinul filters. Source 3The answer is that it has little to do with safety. What's good enough for Canada, Europe, Japan, and Australia will obviously be good enough for the U.S. It has more to do with a thing called the FDA's New Drug Application (NDA) Source 4. You can read more about it in the source. This particular bit about the company that owns (or owned) Avobenzone stands out:"When a drug is approved in the United States, [the NDA covers] both the drug and the formula. So if you want to change the formula, that requires an amended NDA (ANDA), which is not as expensive as an NDA but still a lot of money. The company had developed different lines of the formulation but were called out by the FDA for changing the formula and it would have cost them a fortunate to continue marketing the new formulas.The company finally got advice that you could switch Avobenzone from an ANDA status to a monograph status if you file certain information with the FDA and it’s an almost automatic procedure; except when you do this, you lose your monopoly because anyone can then manufacture it. That’s how it was added to the monograph.The way to go about [adding new sunscreens to the existing monograph] is to follow the Avobenzone pathway. Go to a sunscreen producer, say you will foot the bill to get the NDA approved. Give them, e.g., a three-year monopoly; then after three years, file to switch it to monograph status."IN SHORT, if L'Oreal or BASF were to introduce next-gen filters to the U.S. market, they would have a monopoly over their own patented ingredients for 3 years before being forced to release it into the public domain, or else risk having their sunscreen filters booted from the US market. In other words, L'Oreal would have to squander its exclusive hold over Mexoryl in the US market and allow for the ingredient to be manufactured and used by, say, Banana Boat. This would in turn have a knock-on effect on its Mexoryl patents registered in the rest of the world because Banana Boat sells its products internationally. L'Oreal's patent would be effectively abrogated.IT HAS NOTHING TO DO WITH SAFETY.It has everything to do with politics, protectionism, and outdated, broken laws. And in the end, the American consumer suffers from this silly standoff between the FDA and the corporations.Also, just because a corporation owns an ingredient doesn’t mean Banana Boat or Neutrogena would be precluded from being able to use Tinosorbs and Uvinuls in their formulations. Licensing is a thing! Unlike L'Oreal, BASF freely sells Tinosorbs and Uvinuls to companies that want to use it, just like how BASF sells Tinosorbs and Uvinuls to Japanese manufacturers like Biore, Skin Aqua, Anessa, and Sunplay. But the protectionist measures would hurt BASF as well because the FDA would stipulate that it gives up its patents to Tinosorb and Uvinul and allows other companies to manufacture its proprietary products.Pardon my French, but the FDA has well and truly lost it.
Girls Blog 2015
Submitted by battyboy9
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