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Navigating a Brave New Nature: Cosmetics vs. Drugs

September 29, 2017 | Contact Author | By: Robert H.R. Fichtner, Angela Mazza, M.D., and Anna Schwanke, Focal Point Research Inc., Mississauga, Ontario
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Keywords: active | cosmetic | drug | regulation | claim | Canada | United States | cosmeceutical | epigenetics | elastin | anti-wrinkle | misleading | consumer

Abstract: While many can distinguish a drug from a cosmetic, per regulations in North America, the written text of how a product benefits the skin can determine how it is categorized. In Canada, a product is a cosmetic, a drug or a natural health product. In the United States, a product can be either, or comply with regulations for both cosmetics and drugs.

“Active” ingredients are everywhere in the cosmetics industry. They present formulators with incredible new tools to make products more effective than we ever could have imagined. However, to those of us who have been around a while, we remember when our legal departments prohibited the use of the term active anywhere around a cosmetic. If the marketing department loved an ingredient, it went into the product at 0.00001% with a carefully worded claim and a creative demo for broadcast advertising. Cosmetics were cosmetics, and drugs were drugs, and we treated them very differently. With the exponential developments in science today, this is no longer the case.

It was not until several groups of doctors and scientists approached us that this reality struck home. We were presented with molecules or analogues of molecules that were developed over years in chemotherapy and fundamental genetic research. When we asked about safety testing, we expected to review data similar to what we see for new drugs. However, this was—and typically has not been—the case. It seems many entrepreneurs entering cosmetics research believe the historic tools of human repeat insult patch testing and six-week home trials are sufficient.

We typically see before and after photos of faces, legs and arms showing substantial improvements in wrinkles, aging and other parameters. We dig down deep, looking for regulatory barriers for these projects. Most often, the actives are not on any North American list of restricted or prohibited ingredients. In some cases, the entrepreneurs produce finished-packaged products, ready to be sold. If there are outrageous claims on the packages, we advise they be removed before sale.

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“Active” ingredients are everywhere in the cosmetics industry. They present formulators with incredible new tools to make products more effective than we ever could have imagined. However, to those of us who have been around a while, we remember when our legal departments prohibited the use of the term active anywhere around a cosmetic. If the marketing department loved an ingredient, it went into the product at 0.00001% with a carefully worded claim and a creative demo for broadcast advertising. Cosmetics were cosmetics, and drugs were drugs, and we treated them very differently. With the exponential developments in science today, this is no longer the case.

It was not until several groups of doctors and scientists approached us that this reality struck home. We were presented with molecules or analogues of molecules that were developed over years in chemotherapy and fundamental genetic research. When we asked about safety testing, we expected to review data similar to what we see for new drugs. However, this was—and typically has not been—the case. It seems many entrepreneurs entering cosmetics research believe the historic tools of human repeat insult patch testing and six-week home trials are sufficient.

We typically see before and after photos of faces, legs and arms showing substantial improvements in wrinkles, aging and other parameters. We dig down deep, looking for regulatory barriers for these projects. Most often, the actives are not on any North American list of restricted or prohibited ingredients. In some cases, the entrepreneurs produce finished-packaged products, ready to be sold. If there are outrageous claims on the packages, we advise they be removed before sale.

Today we are hearing forecasts that the active ingredient market for cosmetics will be worth more than $4 billion by 2026.1 Entire suppliers’ portfolios are based on active ingredients. No anti-aging product would dare go to market today without careful consideration and selection of active ingredients. The skin whitening category has exploded with all manners of active ingredients utilizing diverse biochemical modifiers.

This exposes two fundamental questions. One, where do cosmetics end and drugs begin? And two, do these various active ingredients really work? The literature reveals a wide variety of mechanisms for cosmetic actives, including the regulation of many biochemical pathways. Raw material catalogs feature benefits such as “inhibits 5α-reductase,” “stimulates epithelial cell oxygen consumption,” and “rapidly regenerates UV-related cell and DNA damage.” Yet these claims are absent on finished cosmetic products. Instead, phrases like “younger-looking skin,” “softens skin,” or “helps prevent the look of aging” are used. If the active ingredients really do what they advertise, these claims cannot be used on product labels and marketing material because that would make them drugs.

Both ingredient suppliers and brand owners must ensure they have the evidence to prove product claims and safety, especially for long term use and in vulnerable populations.

Cosmetic or Drug? Regulating Claims

In the U.S. and Canada, there are firm restrictions on claims cosmetic products can make. First, they must not make therapeutic claims such as references to treating or preventing a disease. Second, they cannot claim to alter the structure or function of the body. Lastly, they cannot be misleading to the consumer.2, 3

The term cosmeceutical is not recognized or defined by regulators in either country. In Canada, a product is a cosmetic, a drug or a natural health product.2 In the United States, a product can be either, or comply with the regulations for both cosmetics and drugs.4 But with the advance of science such as epigenetics, cosmetic products may stumble into the grey zone of these two categories. Sadly, the regulatory architecture for cosmetics in North America was built in the 1930s and 1940s, for products like lipsticks and shampoos, and is woefully out of date. In fairness, federal health regulators are swamped with countless urgent priorities, all of which can take precedence.

Epigenetics—Going One Step Further?

In the past, cosmetic science was largely driven by chemistry and the innovations involved, delivering enhanced benefits in cleansing, conditioning, moisturizing, etc. However, recent work expanding our understanding of genetics is pushing the industry toward biology-based cosmetic formulation. For example, in the last few years, we have seen an increase in the mention of epigenetics for skin care.

Epigenetics cause specific tissue changes by reprogramming cells without altering their DNA sequences.5 Chemical compounds act on the genome to alter what it does, as well as when and where. An important epigenetic reaction is the regulation of methylation. Altering methylation patterns allows enzymes to attach to DNA and turn genes on.5 Understanding epigenetic regulation has allowed us to improve the accuracy and efficiency of active ingredient delivery by targeting fundamental cellular and genetic processes. While this fast-moving corner of biology is an exciting development in skin care, it raises some questions.

First, we know that cosmetic products cannot claim to alter the structure or function of the body. Yet this is what these active ingredients are meant to do, not only macroscopically, but also on cellular and genetic levels. Health Canada and the U.S. Food and Drug Administration guidelines clearly state that acceptable cosmetic claims cannot make any reference to action at the cellular or even tissue level, working from the inner layers of the skin outward or influencing collagen, elastin, enzymes or other similar components of the body.6, 7 These are the exact actions promised by many active ingredients.

Beyond the regulatory aspects, these actives also pose safety questions. What is the potential impact on ecosystems when products containing these actives are disposed of, or washed down the drain? What happens when plant and animal organisms take up epigenetic-altering substances into their tissues? Epigenetic changes are durable, are inclined to spread to non-target tissues and can be transmitted from one generation to the next.8 Are there safety concerns for pregnant or lactating users of products containing these technologies? And has the potential impact on reproduction and fertility been studied?

Many proteins and enzymes that are the epigenetic targets of anti-aging products are also essential to other body functions. Elastin, for example, plays a role in wrinkle prevention as well as being key to lung compliance for normal breathing.9 In our development of these new ingredients, are we adequately studying their percutaneous absorption and potential systemic effects?

These are all questions we carefully address when presented with new drugs and even some oral nutritional supplements. What makes cosmetics more challenging is we cannot assess their safety using animal models like we do for drugs, and we typically do not see the phased approach to testing human exposure, starting with Class I clinical trials on small numbers of subjects.

If cosmetics cannot make drug claims, yet they demonstrate drug activity, is this misleading the consumer by omission?

Misleading by Omission?

The other regulatory consideration is the constraint that cosmetic product claims must not be misleading to the consumer. Traditionally, this has been thought of in the context as promising unrealistic benefits. But if consumers are unaware of the effects of cosmetic active ingredients at a cellular level, is this misleading by omission?

As a hypothetical example, two products could have the exact same formula, intended use and level of active ingredient. One of them claiming to “give the skin radiance” would be regulated as a cosmetic, while the other claiming to “maximize skin cell turnover” would be a drug. If marketed as a cosmetic, the question is, do consumers have the right to know that what they're putting onto their skin is turning genes on/off, inhibiting/stimulating enzymes, accelerating cell turnover, or influencing free radical scavenging?

Protecting the Industry and the Consumer

With the aforementioned promising forecast for the actives market, it is likely the use of sciences such as epigenetics in cosmetics will continue to thrive. Does our industry have sufficient safeguards in place to assess risks to human health and the environment? Both ingredient suppliers and brand owners must ensure they have the evidence to prove product claims and safety, especially for long-term use and in vulnerable populations such as children, pregnant and lactating women and the immunocompromised. Innovators working on the frontier of these cosmetic sciences would be well-advised to study some of the models used in drug development and determine if any could be applicable to their technology. Developing a cosmetovigilance plan should become routine.

With increasing consumer concerns for product safety and the ever-present watchful eye of NGOs, we must continue to innovate for all the exciting possibilities but do so with caution. As an industry, we must be careful in the excitement of innovation and new science so we are not blind to safety and ethical considerations as we navigate this brave new world.

References

All websites accessed on Aug. 28, 2017.

  1. marketsandmarkets.com/PressReleases/active-ingredient-cosmetic.asp
  2. canada.ca/en/health-canada.html
  3. www.fda.gov/cosmetics/labeling/claims/ucm2005200.htm
  4. www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
  5. H Epstein, RJ Gadberry and MR Rosen, Understanding the value of molecular cell biology and gene analysis for the next generation of cosmetic products, Harry's Cosmeticology 9(1) (2015)
  6. MA Rothstein, Y Cai and GE Marchant, The ghost in our genes: Legal and ethical implications of epigenetics, Health Matrix: J of Law-Medicine 19(1) 1-63 (2009)
  7. BC Starcher, Elastin and the lung, Thorax 41 577-585 (1986)
  8. www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
  9. www.fda.gov/cosmetics/labeling/claims/ucm2005200.htm