Who Is Responsible For Substantiating The Safety Of Cosmetics? You Are.
"People don't realize there is effectively no regulation of cosmetics."
Representative Frank Pallone Jr., Democrat of New Jersey
“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.”
Official FDA website
"The cosmetic industry remains largely self-regulated.
History has repeatedly shown that when there is insufficient regulatory oversight,
unscrupulous people or companies will exploit the vulnerable public for profit.”
Dr. Robert M. Califf, FDA Chief under President Obama
“Unlike pharmaceutical companies, cosmetic companies are not required to notify the government of 'adverse reaction' reports - even if someone dies."
Eric Lipton & Rachel Abrams, The New York Times
Most consumers assume that the FDA regulates skincare products the same way it does drugs...It does not. The FDA must approve all drugs before they go to market. This involves short- and long-term testing on animals, then people, to make sure the drug is not toxic and has no long-term side-effects. The FDA assumes responsibility for drug safety. So, to develop, test and sell a drug is a long, drawn-out, prohibitively expensive process, but anyone can put anything in a jar and legally sell it as skincare because the FDA only minimally monitors and reactively regulates cosmetics.
The Federal Food, Drug, and Cosmetic Act (FD&C) Act [sec. 201(i)] defines drugs and cosmetics based on their intended use, rather than their effects on you. Drugs are 'articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease' and 'articles (other than food) intended to affect the structure or any function of the body of man or other animals’. Cosmetics are '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'. A product is both a cosmetic and a drug when it meets both definitions. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, a serum with SPF, and moisturizers and makeup marketed with sun-protection claims.
Such products must comply with the requirements for both cosmetics and drugs, but, more often than you would assume and believe, cosmetics contain chemicals that act as drugs, but are not approved and circumvent any regulation by the FDA because the definitions of drug and cosmetic are based on intended use rather than actual effects on your body.
The manufacturers of these functional drugs masquerading as cosmetics blatantly skirt and evade FDA scrutiny and rigor by hiding behind pointedly misleading nomenclature, verisimilitude and pseudoscience…Cosmeceuticals, Pharmapseudocals, Pharmametics, Pharmamedics…Alchemy, anyone?
For example, an ingredient in Peter Thomas Roth MegaRich™ Intensive AntiAging Cellular Eye Crème was initially described and marketed as, "Tetrapeptide and Oligopeptide - Peptides that work synergistically to help promote collagen production while helping to stimulate fibroblast cells in the skin," which is fairly accurate. But, according to the FD&C Act, this makes the product a drug because it is intended to change the structure and function of your body. After receiving a warning letter from the FDA, the description was replaced with, "Tetrapeptide & Oligopeptide - peptides that work synergistically to help improve the look of skin firmness while helping to reduce the appearance of wrinkles." The ingredients in the product remain the same and have the same effect on your skin cells and health. Except, now you are led and expected to believe that these same ingredients somehow are benign and not intended to change your body structure and function. Skincare products like these are not benign; they are specifically intended to alter your body structure and function…They're drugs.
Nutrients in isolated and artificial forms and concentrations also have drug-like effects. In fact, “Vitamin C is a potent antioxidant drug that can be used topically in dermatology to treat and prevent changes associated with photoageing.” (Indian Dermatology Online Journal). It’s easy to overdose on vitamin C concentrated into a capsule or cream. It’s almost impossible to overdose on naturally-occurring vitamin C in whole foods. There are only so many oranges, lemons, and limes you can eat and/or use on your skin before the vast quantities of fiber and acid in or on your body will cause it to very obviously object to any more, at a far lower dose of vitamin C than you would receive in a capsule or cream.
Nutrients in whole foods are the building blocks with which your body evolved and uses most efficiently to grow and repair. And, unlike the isolated and artificial forms and concentrations of nutrients found in supplements and skincare products, the concentrations and chemical structures of the nutrients present in whole foods do not circumvent any of the built-in metabolic feedback loops your body developed to prevent harmful side-effects that may progress to disease.
Cosmeceuticals, part cosmetic and part pharmaceutical, are risky to use, because, although they have drug-like effects, there is no data on how they affect your long-term health. The existing “clinical” “data” is usually from in-house studies that are incredibly small (30-40 people), short term (hours to weeks), and focused on subjective outcomes (the look and feel of skin as judged by the participant) that forward the manufacturers’ goal of selling and moving product.
Most cosmeceuticals are effective in helping you temporarily achieve an illusion, the unrealistic and unsustainable definition of beauty as young and flawless-looking. But, at what risk? Is indulging your vanity worth risking your health?
It’s up to you.
Don’t know where to start? Read my guide on how to choose skincare for health and read my previous Op Eds in the Davis Enterprise to learn more about skin care that supports your health.
A version of this blog post is published in my local newspaper, the Davis Enterprise. There is no paywall to view my articles in the Davis Enterprise. Simply click the X in the red circle to read my article.