New Concepts in Cosmetic Regulations. . .It's Time to Leave the 1930s Behind

November 17, 2016 | Contact Author | By: Robert Ross-Fichtner, Claire Robichaud, Layne L'Abbe and Dayna Lozon, Focal Point Research Inc. Mississauga, ON
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Keywords: regulation | cosmetic | drug | history | risk | Focal Point Research | FDA | cross-category | SPF | innovation | harmonization

Abstract: In the days when lawmakers were penning the original rules, understanding the differences between 'cosmetics' and 'drugs' was an easy business. These terms have run their course and really no longer suit the industry.

A few years ago, a report showed there is a law on the books in North Dakota making it illegal to serve beer and pretzels at the same time in a drinking establishment. In Missouri, evidently there is an ancient law prohibiting someone from driving down the highway with an uncaged bear in the car. These are examples of countless laws passed decades ago, which surprisingly are still on the books.

Similarly, in North America, laws pertaining to cosmetics are antiquated and have fallen woefully behind innovations in science, consumer habits and general common sense. There are significant efforts underway to correct the situation, but are they enough?

History of Cosmetics Regulation

Passed in 1938, the U.S. Food, Drug and Cosmetic Act still rules over cosmetics in the United States. That year, MGM Studios announced Judy Garland would be cast as Dorothy in the Wizard of Oz, and Studebaker opened a new car manufacturing plant in Vernon, California, to supply cars to the U.S. population—which was a mere 130 million.

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A few years ago, a report showed there is a law on the books in North Dakota making it illegal to serve beer and pretzels at the same time in a drinking establishment.1 In Missouri, evidently there is an ancient law prohibiting someone from driving down the highway with an uncaged bear in the car.1 These are examples of countless laws passed decades ago, which surprisingly are still on the books.

Similarly, in North America, laws pertaining to cosmetics are antiquated and have fallen woefully behind innovations in science, consumer habits and general common sense. There are significant efforts underway to correct the situation, but are they enough?

History of Cosmetics Regulation

Passed in 1938, the U.S. Food, Drug and Cosmetic Act still rules over cosmetics in the United States.2 That year, MGM Studios announced Judy Garland would be cast as Dorothy in the Wizard of Oz, and Studebaker opened a new car manufacturing plant in Vernon, California, to supply cars to the U.S. population—which was a mere 130 million.

Canada’s Food and Drugs Act is even older; it dates to 1920. It’s been updated a few times and Canada has had some significant innovations in cosmetic regulations, such as the Hotlist and the development of Natural Health Products regulations. We often point to Europe, where cosmetic regulations have seen explosive growth.3 But are Europe’s regulations truly innovative? In our view, much of the world is working with Studebaker-architecture in a Google-car world.

In the days when lawmakers were penning the original rules, understanding the differences between cosmetics and drugs was an easy business. Cosmetics like lipstick, rouge, pressed powders and perfumes occupied a lot of the cosmetics universe at that time. Drugs were also well-defined. Aspirin was the go to if you had a headache. Antibiotics were big news in the 1930s and were fast-evolving, life-saving innovations. It was not difficult for regulators to draw the line between these two categories of products.

Since regulations often come from a "What can go wrong?" mentality, problems with cosmetics were limited back then. They could be contaminated with something nasty or they could have misleading information on the label. These potential issues gave rise to the U.S. Food and Drug Administration's (FDA’s) well-established terminology of “adulterated” and “misbranded,” respectively.4 It’s interesting how the original U.S. and Canadian laws did not give regulators the ability to recall cosmetics, firmly establishing their perspective that these were hardly worth the regulatory time of day.4

World War II saw massive innovations in chemistry. Starting with plastics, more cosmetic packaging changed from glass to plastic, which was so much lighter and unbreakable.5 But the magic that could be put into the bottle was about to begin. This gave rise to products that could hardly be envisioned when the original North American cosmetic laws were developed.

Cross-category Technology

The cosmetic industry's constant innovation has given rise to what we often call cross-category technology. Today's consumers look to products providing multiple benefits such as hydration, sun protection, moisturization, anti-aging, blemish relief and oil control all at once. Consumers are clearly looking to get the most benefits from the fewest number of products possible.6 This is especially prevalent with anti-aging products;6 these multifunctional wonders save the consumer time and money.6 However, trying to combine multiple benefits into one bottle can make it difficult for a product to remain a cosmetic. It then becomes challenging to sell something that is technically only a cosmetic to the consumer without making drug claims. This, of course, would require it to be regulated as a drug.

Antiquated Terms Collide With Modern Reality

The real issue is the use of the antiquated concepts of “cosmetic” and “drug” in today’s cosmetic world. This puts a large strain on regulators and the industry, both of which are struggling to compartmentalize innovations that really don’t have a regulatory home. Simply put, the terms cosmetic and drug have run their course and really no longer suit the industry.

Walking down the aisles of a pharmacy or high-end retailer, you'll see the dizzying number of products that can be applied to skin. A modern regulatory architecture needs to sort out how to assemble these as a function of risk and benefit.7 Risk/benefit is at the heart of all regulatory schemes and is what the world has been grappling with in this modern and fast-moving world of cosmetics.7

Consider this historical perspective. Table 1 shows a comparative list of 1938 vs. 2016 cosmetics, including products the authors have seen in the course of their work. Today, use of the term active ingredient is ubiquitous in cosmetic science.8 It’s not uncommon to see language such as regulates organic functions, promotes synthesis, up- and down-regulates and inhibits degradation all within the context of cosmetic active ingredients. Reading the scientific literature, a great deal of cosmetic science involves understanding the biochemical pathways of active ingredients and their benefits to skin.8

Sadly, our approach today is to try to force-fit every product into a 1938 category. SPF products are the poster child for this. Depending on the jurisdiction, these products are cosmetics, drugs, cosmetics and drugs, natural health products or another category invented by the local regulatory authority.9 The reality of today is that we're dealing with a broad universe what we will call Topically Applied Skin and Hair Products (TASHP). These cover a wide range of risks and benefits (see Figure 1).

Between the two ends of the spectrum are countless sub-categories of topical products. We need to decide where on this continuum to place products like a 30% acid peel, SPF 50, acne products, permanent (injected) makeup, biologically active cosmetics and many other innovative and complex topical products. Furthermore, does placement on such a spectrum depend on sub-populations? For example, are there additional risks or benefit factors amongst pregnant or lactating women, the elderly, the immunocompromised, etc.?

An excellent modern regulatory scheme that truly assesses risks for a regulated category is medical devices. Regulators have tremendous agreement around the world as to how to regulate these products.10 For example, a bandage is considered a class I medical device; its risk is minimal and its benefit is small. An implantable cardiac pacemaker is a class III or IV, depending where you live; its risks and benefitss are considerable. The world agrees on the ISO 13485 quality system to make these products, and we can travel around the world and speak the same language.10 Harmonization like this has dramatic effects on the flow of trade and significantly reduces costs and inefficiencies. We need this desperately in the cosmetic category.

Regulatory Innovation

All this brings us to the state of cosmetic regulations today. Countries like China and Brazil do not see cosmetics as a single category. Their approach focuses on higher-risk cosmetic products and these require more extensive regulatory control; this is innovative, progressive thinking in regulations. Canada just launched a consultation on a regulatory architecture where cosmetics, OTC drugs and nutritional supplements would be considered one group of “Consumer Health Products,” using a risk-based approach.11

In the United States, two new bills have been proposed to revise cosmetic regulation. Interestingly, the Sessions Bill includes a provision to allow cosmetics to make structure/function claims.12 This is true cosmetic regulatory innovation. However, most of the other considerations of the two proposed bills, such as mandatory product registration, reporting adverse reactions, etc., involves adding new features to the existing regulatory structure.12 They are absolutely important features but frankly, could have been implemented years ago.

Most current attempts to revise cosmetic regulations build on the 1938 foundation and amount to adding air-conditioning to the Studebaker. What is really needed is a complete rethink of the category based on the risks and benefits established for the many innovative categories in the world of cosmetics. Failure to do this will only exacerbate the problem as the pace of innovation in the industry will only accelerate.

We must consider some of the innovative regulatory architecture being developed worldwide and remain open-minded as we look to harmonize global approaches to regulating topically applied products. To achieve this, we must agree on the risks and benefits of the various categories of these products. How we do this is uncertain, and no doubt extremely controversial. The need to make progress, however, is our only hope to properly regulate this category and drive the industry toward global harmonization.

References

  1. www.legalzoom.com/articles/top-craziest-laws-still-on-the-books
  2. www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ucm132818.htm
  3. https://ec.europa.eu/growth/sectors/cosmetics/legislation_en
  4. www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074248.htm
  5. www.plasticsindustry.org/AboutPlastics/content.cfm?ItemNumber=670
  6. www.cosmeticsdesign-europe.com/Market-Trends/Trend-watching-at-the-in-cosmetics-Marketing-Trends-presentations
  7. www.ispor.org/workpaper/risk_benefit_management_guo.pdf
  8. www.prime-journal.com/the-science-behind-skincare/
  9. www.hc-sc.gc.ca/dhp-mps/consultation/natur/sunscreen-ecransolaire-eng.php
  10. www.iso.org/obp/ui/#iso:std:iso:13485:ed-3:v1:en
  11. http://healthycanadians.gc.ca/health-system-systeme-sante/consultations/selfcare-autosoins/document-eng.php
  12. www.congress.gov/114/bills/hr4075/BILLS-
    114hr4075ih.pdf
 

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Table 1. Cosmetics Then and Now

Table 1. Cosmetics Then and Now

Comparative list of 1938 vs. 2016 cosmetics, including products the authors have seen in the course of their work.

Figure 1. Risk/Benefit Range

Figure 1. Risk/Benefit Range

The reality of today is that we're dealing with a broad universe what we will call Topically Applied Skin and Hair Products (TASHP). These cover a wide range of risks and benefits.

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