Action Kosmetik
Skye Severy
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Feature papers represent the most advanced research with significant potential for high impact in the field. A Feature Paper should be a substantial original Article that involves several techniques or approaches, provides an outlook for future research directions and describes possible research applications.
Abstract: The utilization of topical formulations containing alpha hydroxy acids (AHAs) has garnered considerable attention. This review summarizes the effectiveness of the most common topical AHA formulations, including mechanisms of action and future research directions. AHAs have a dramatic impact on diverse skin conditions, enhancing texture and stimulating collagen synthesis. Uncertainties persist regarding optimal concentration, pH, and vehicle for maximum efficacy. Advancements in formulation technologies offer opportunities for AHA penetration and stability. Understanding mechanisms is vital for skincare optimization. The review covers AHAs, their concentrations, formulation considerations, safety measures, and future directions. Keywords: AHA; glycolic acid; lactic acid; citric acid; photoaging; hyperpigmentation; acne
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The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.
The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). FDA regulates cosmetics under the authority of these laws.
In the United States, federal laws are enacted by Congress. In order to make the laws work on a day-to-day level, Congress authorizes certain government agencies. such as FDA, to create regulations. A change in FDA's legal authority over cosmetics would require Congress to change the law.
The FD&C Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FD&C Act, sec. 201(i)). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. It does not include soap. (To learn what products are considered "soap" for regulatory purposes, see "Soap."
"it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual" (with an exception made for coal-tar hair dyes);
its label does not include all required information. (An exemption may apply to cosmetics that are to be processed, labeled, or repacked at an establishment other than where they were originally processed or packed; see Title 21, Code of Federal Regulations, section 701.9.)
Under the FD&C Act, a product also may be misbranded due to failure to provide material facts. This means, for example, any directions for safe use and warning statements needed to ensure a product's safe use.
In addition, under the authority of the FPLA, FDA requires a list of ingredients for cosmetics marketed on a retail basis to consumers (Title 21, Code of Federal Regulations (CFR), section 701.3). Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act. (FPLA, section 1456) This requirement does not apply to cosmetics distributed solely for professional use, institutional use (such as in schools or the workplace), or as free samples or hotel amenities.
FDA's legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA.
FDA has consistently advised manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that "the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information." (Federal Register, March 3, 1975, page 8916).
Although FD&C Act does not subject cosmetics to premarket approval by FDA, we do collect samples for examination and analysis as part of cosmetic facility inspections, import inspections, and follow-up to complaints of adverse events associated with their use. FDA may also conduct research on cosmetic products and ingredients to address safety concerns.
FDA does not function as a private testing laboratory, and in order to avoid even the perception of conflict of interest, we do not recommend private laboratories to consumers or manufacturers for sample analysis.
Under the law, manufacturers are not required to register their cosmetic establishments or file their product formulations with FDA, and no registration number is required to import cosmetics into the United States.
However, we encourage cosmetic firms to participate in FDA's Voluntary Cosmetic Registration Program (VCRP) using the online registration system. Cosmetic manufacturers, distributors, and packers can file information on their products that are currently being marketed to consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP database. To learn more and access this program, see Voluntary Cosmetic Registration Program (VCRP).
The proposed class action detailed on this page was stayed (that is, put on hold) and administratively closed in light of Morphe parent company Forma Brands filing for Chapter 11 bankruptcy on January 12, 2022.
On January 12, Forma Beauty Brands LLC filed a five-page notice with the court that states the company, Morphe and several related entities commenced bankruptcy cases in Delaware. The following day, U.S. District Judge Jon S. Tigar issued an orderstating that the case detailed on this page is subject to an automatic bankruptcy stay and closed for administrative purposes.
Moreover, the lawsuit contends that Morphe has encouraged consumers to use the products at issue near their eyes by including in its advertising pictures of models wearing the cosmetics as eye makeup. Included in the complaint are the following images, which respectively purport to depict Morphe's advertisements for Colorfix 24-Hour Cream Color Neons in the shade UFO (neon yellow) and Colorfix 24-Hour Cream Color Mattes in the shade Valentine (bright pink), even though these two shades allegedly contain harmful color additives:
The third plaintiff, a Wahiawa, Hawaii resident, also claims to have experienced skin staining as a result of using Morphe products, including the Morphe 35O, Morphe 35M, Morphe 35W, Morphe 9C, and Jaclyn Hill eyeshadow palettes.
The plaintiffs each allege that when they purchased the Morphe products, they were unaware of any warnings or disclosures that the makeup contained harmful color additives that were unsafe for application to the eye area.
A reaction to surgical Mesh from a surgery led to my MCAS diagnosis when I was 40. Even with treatment, MCAS continues to impact all aspects of my personal and social life; such as the need for regular hospital admissions because of anaphylaxis. After months of extensive testing, the doctors were completely baffled. All my tests were coming back normal. When I found out that titanium clips had been left inside me, I asked for a metal allergy test, which produced a weakly positive result.
After another operation to remove the titanium clips that were left inside me, I quickly made an almost complete recovery. However, the operation left me with an incisional umbilical hernia, and I had the hernia repaired using surgical mesh. Within days the problems started again, and all the previous symptoms returned. The doctors began more extensive testing, looking at more and more unusual conditions. During this time, a fellow HEDS sufferer mentioned MCAS to me.
After my first dose of medication, I had a major reaction followed by a period of major instability, where I had 10 anaphylactic reactions in 3 weeks. I spent a lot of time in hospital, was unable to eat for long periods of time, and at one point could not even drink water. The only medications that stabilised me long enough for the mesh removal operation were high doses of steroids and antihistamines.
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