The Blurred Line Between Drugs and Cosmetics

By Kiki Ngernanek

Drugs as cosmetics or cosmetics as drugs or both? Consumers like you and I are blinded by the marketing claims and sugar-coated truths about the origin of products we use daily. According to the Federal Food, Drug and Cosmetic (FD&C) Act, cosmetics are defined 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”. Conversely, drugs are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, prevention of disease or intended to affect the structure or any function of the body”.¹ Simultaneously, the term ‘cosmeceuticals’ has been widely used in the personal care industry, where the product is a mixture of both cosmetics and drugs⁵, however this term has not been officially recognized by the FD&C Act, leading to multiple controversies in this field of research. In addition, the most cutting-edge advancement of cosmetics research is utilising genetic profiling for specific skin care, biotechnology-derived ingredients and stem cell therapies to restore aging tissues.²

The most common products regulated as cosmetics include skin moisturiser, shampoo, toothpaste, lipstick and deodorant. These do not have intended harmful, toxic or permanently changing effects on bodily functions.³One of the main reasons for the research and development of cosmetics is that they’re not required to undergo clinical trials and extensive tests for efficacy, unlike drugs. For example, biotechnology companies that are focusing on enhancing DNA repair have successfully licensed some products to the cosmetic industry without the lengthy process. Thus, these companies could perceive this as an advantage to use their finance on alternative research. On the other hand, cosmetics companies want to ensure that their products are clearly distinct and don’t undergo the same regulation as therapeutic drugs. Ultimately, this is left to the regulatory agencies to make the final decision whether a product is identified as a drug or cosmetic. As well as creating regulatory complications, many beauty products falsely claim that they have gone through detailed scientific research which leads to the assumption that they’re as effective as drugs.²

Acne, dandruff, hair loss treatments, and skin protectants (sunscreen) are regulated as drugs.⁴ The main defining factor whether a product is a cosmetic or drug depends on the concentration of ‘active ingredients’. These are chemicals that have been scientifically proven to generate effective therapeutic outcomes to enhance efficacy, such as vitamin c, hyaluronic acid, retinol, SPF and benzoyl peroxide. According to a review article by Pandey et al.⁵, sunscreen with SPF less than 4 is classified as cosmetics and higher SPF sunscreens are approved for sale over-the-counter (OTC). However, a recent proposal by the FDA suggests that all sunscreens with SPF are considered as drugs. Moreover, there’s still ongoing disagreement whether labelling minoxidil, which is used to treat baldness in men, should be based on its pharmaceutical effects rather than the intended condition the product is supposed to alter.⁵ This highlights the multiple factors that must be considered and that there’s a very fine line between understanding the product and putting a solid label on it. 

Some of the most common active ingredients in cosmeceuticals to treat damaged and aging skin are hyaluronic acid, vitamin C and retinol. The key characteristic of aging skin is fragmentation of the collagen matrix caused by the metalloproteinases. Therefore, the active ingredients mentioned above aim to decrease collagen collapse and promote its production. Benzoyl peroxide (BPO), which is typically used as facial cleansers, is a critical component to treat and reduce acne. BPO directly kills Propionibacteirum acnes and other bacteria, unlike antibiotics whose mechanism of action involves modifying the bacterial structure and specific enzymes. Following the wash, pores open, reducing swelling and removing outer layers of the affected skin cells, giving an opportunity for new ones to proliferate.⁶ Keep in mind that skin rejuvenators and cleansers are only two of the countless products we use daily but fail to realise the actual ingredients as they have been normalised and poorly regulated throughout the years. Because of this, long term use may have unforeseen impacts on physical health. 

Living in an ever-changing world where technology is the core of healthcare improvement and disease prevention, this could expose more modern solutions to current problems. For example, stem cell technology has been a growing interest in medical research, especially for Alzheimer’s disease. Since anti-aging is a shared goal amongst the population, topical applications of mesenchymal stem cells (MSCs) in skin rejuvenation and regeneration have been explored. Aged skin is associated with increased risk of diseases, including dermatitis, eczema and melanoma, as well as increased oxidative and metalloproteinase activity. In skin rejuvenation, MSCs have the potential to reproduce collagen and elastic fibres and inhibit metalloproteinase activation.⁷ A South Korean biotechnology company, RNL Bio, is developing a stem-cell based cream that utilises the anti-aging properties of the human placenta. Instead of extracting the active ingredients directly from the placenta, the proteins are obtained from cultured placenta stem cells as it’s believed to produce more active and stable compounds.²

In conclusion, the beauty industry is constantly evolving where the integration of medical research starts to play a role in advanced skincare development to fulfil the increased aesthetic standards. Therefore, it falls to us as consumers to be aware and selectively identify products to prevent long-term effects. Furthermore, recent studies have shown potential use of MSC transplantation in skin cell therapy⁷, however further research underlying the molecular mechanisms are required to guarantee safe implantation and to fully understand its potential side effects. 

References:

1. U.S. Food & Drug. Is it a cosmetic, a drug or both? (Or is it a soap?). Available at: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap[Accessed on 29/11/22]
2. Rinaldi A. Healing beauty? More biotechnology cosmetic products that claim drug-like properties reach the market. 2008 November 2008;9(11).
3. What’s The Difference Between A Cosmetic And A Drug (And Why It Matters)?. Available at: https://www.beautifulwithbrains.com/whats-the-difference-between-a-cosmetic-and-a-drug/[Accessed on 29/11/22]
4. U.S. Food & Drug. Are all “personal care products” regulated as cosmetics? Available at: https://www.fda.gov/industry/fda-basics-industry/are-all-personal-care-products-regulated-cosmetics[Accessed on 29/11/22]
5. Pandey A, Jatana GK, Sonthalia S. Cosmeceuticals. 2022 8 August 2022.
6. J Clin Aesthet Dermatol. What is the Role of Benzoyl Peroxide Cleansers in Acne Management?. 2008 November 2008;1(4).
7. Marfia G, Navone SE, Di Vito C, Ughi N, Tabano S, Miozzo M. Mesenchymal stem cells: potential for therapy and treatment of chronic non-healing skin wounds. 2016 18 February 2016;11(4).