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PDF-XChange Editor · PDFescape review · PDFsam Basic review because it is listed as an inactive ingredient on product labels; therefore, retinol is not intended to serve a biologic purpose As in several other realms of society during our era of rapidly propagating technology, numerous legal implications fail to anticipate future developments In terms of the debate over classifying products as drugs, cosmetics, or cosmeceuticals, there are some salient points to consider The first is that the current regulations discourage companies from publishing supportive scientific clinical trials to evaluate the efficacy of their products For example, if a manufacturer establishes in a study that an ingredient increases collagen synthesis, the company is proving that its product affects the function of the body If they were then to market or sell that product as a cosmetic intended to increase collagen synthesis, as would be desirable in an antiaging product or a wrinkle cream, they would be violating the 1938 statute The only legal option for the manufacturer would be, instead, to market its product as a drug Before approval for marketing in the United States, every new drug must be clinically tested in accordance with FDA guidelines for a new drug application (NDA) The FDA process of drug approval can take more than 10 years and cost hundreds of millions of dollars Obviously, the cosmetic companies are left with compelling incentives to avoid such long delays and exorbitant costs by following the guidelines to keep their products classified as cosmetics In such cases, even though the companies perform extensive research on such products, their findings are considered proprietary and remain unpublished This, too, has several implications The first is that dermatologists and other physicians do not have access to this scientific evidence and are rendered poorly equipped to evaluate the efficacy of the numerous and varied products making it to market Physicians are taught to practice evidence-based medicine, but without evidence, have little reason to believe that any of these products are efficacious or effective Consequently, the medical establishment dismisses these products as useless when such formulations may, in fact, offer potential benefits to patients The second problem is that consumers may often become confused by all the sleek, glitzy marketing They rarely know how to tell the difference between a reputable company that conducts scientific research and a company of charlatans seeking to capitalize on consumers dreams of younger and healthier skin With little guidance given the medical community s lack of information regarding these OTC products, consumers try products and likely feel disappointed with the lack of results Consumers are also left to operate under the false assumption that you get what you pay for that is, the more expensive the product, the more likely it is to be effective This can lead to a general distrust of the entire cosmetic dermatology field The third problem with cosmetic companies performing internal research and not publishing the results for general review is the circumvention of the peer review process Peer review has long been considered essential to validate the research findings of scientists It is difficult to believe or have confidence in the results of a study that has not been subjected to the peer review process Also beyond the peer review process, there are individuals outside of companies that attempt to perform research on cosmetic products and procedures without the concern for product classification; 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