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Massive Innovations, Complex Regulations: The Entanglements of Hair Care Products

Contact Author Robert Ross-Fichtner and Daniel Noble, Focal Point Research Inc., Mississauga, Ontario
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No aspect of the human anatomy endures the love-hate relationship we share with our hair. In some cases, we spend endless time and money to get rid of it, spawning all sorts of shaving, depilatory, waxing and laser technologies. Enormous innovation underpins all of these categories, and each possesses its own regulatory challenges.

On the other hand, we are absolutely obsessed with our hair; wanting more of it, and again spending seemingly limitless time and money to grow, condition, color or perm it. This spawns even more technologies and leads to some very important regulatory challenges.

Hair Removal and Growth

For consumers wanting less hair, the regulatory menu of possibilities covers products such as razors, cosmetics (e.g., shaving foams, depilatories) and medical devices (e.g., lasers). Each of these categories requires new products to meet totally different regulatory paradigms before they reach the market. Enforcement actions from regulators for these products would typically address safety-related complaints from more extreme and permanent forms of hair removal.

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Techniques such as laser hair removal require skilled and well-trained operators, using carefully controlled medical devices that have been thoroughly vetted by regulatory agencies and manufactured to International Organization of Standardization (ISO) quality standards. Electrolysis is another procedure requiring a sophisticated medical device to remove hair and prevent the regrowth of hair follicles.1 These devices provide an electric current that produces a chemical reaction within hair cells to render their function inert.1

Things get even more interesting for consumers wanting more or better hair. The regulatory menu of possibilities in this case is larger and includes accessories such as brushes and rollers; cosmetics such as shampoos, conditioners, styling products and hair dyes; medical devices, i.e., various radiation-emitting devices to encourage hair growth; dietary supplements containing “hair food”; and topical drugs that promote eyelash and hair growth, treat dandruff, etc. In these cases, enforcement actions from regulators might address safety-related complaints, environmental concerns and promotional claims made about products.

It is worth noting that the complaints regulators face in hair growth/removal and other categories often arise from non-governmental organizations (NGOs). Such non-profit groups have strong voices on issues of human health and environmental safety, and aim to promote regulatory changes and influence consumer purchases. Outside of government regulation, these organizations assist in informing consumers of regulatory policy debates and providing information on products and ingredients. However, their effectiveness is sometimes dependent upon ill-informed consumers. Indeed, NGOs have influenced choices for hair dye ingredients, preservatives and the use of siloxanes—all of which have also been scrutinized by governmental bodies.

Hair Dye Oversight

In terms of safety, hair dyes have been subjected to a great deal of regulation. Numerous publications have expressed concern about increased bladder cancer rates among hair styling professionals.2 Interestingly, due to a scientific study published in 2001 titled, “Use of permanent hair dyes and bladder cancer risk,” European Union (EU) Regulation No. 1197/2013 came into effect, in which Annex III restricted the use levels of some 21 hair dyes.3

Health Canada specifically plans to re-examine coal tar dyes, and Canada’s Chemical Management Plan has other ingredients flagged for further assessment. These ingredients are under safety data review, which may amount to further restrictions on the Canadian Hotlist. If so, similar to EU Regulation No. 1197/2013, Canada may employ maximum permitted concentrations, or other restrictions.

Regarding U.S. hair-dye regulations, coal tar dyes are included under the federal Food, Drug and Cosmetic (FD&C) Act (Chapter VII, section 721).4 Astoundingly, these dyes are excluded from the U.S. Food and Drug Administration’s (FDA’s) approval process, which is required for colorants to be used in food, drugs and cosmetics.5

Adulteration provisions held under the FD&C Act prohibit any product from containing chemicals that may cause harm to a consumer.6 Coal tar-based hair dyes are exempted from adulteration provisions but are prescribed by law to include labels with cautionary statements and “patch-test” instructions.4 Other dyes for eyelashes or eyebrows are not a part of the exemption6 and would therefore require approval by the FDA for their designated use.

Interestingly, the exemption of coal tar dyes dates back to 1938, when the Food and Drugs Act of 1906 was replaced by the FD&C Act.7 This law introduced cosmetics to the Act and included the need for them to consider consumer safety. Controversially, coal tar hair dyes manufactured at that time were noted to cause allergic side effects.7 As the FDA prepared to release the new law, which would likely have banned the sale of hair dyes due to these health concerns, the industry lobbied and successfully exempted coal tar dyes from the adulteration provisions.7

Preservative Challenges

Industry experts regularly express concerns over the ability to adequately preserve water-based products, especially with the ever-narrowing menu of preservative options. Many hair cleaning and enhancing products are water-based, making them a big challenge for preservation. Not long ago, parabens were the first and best choice for preservation but thanks to endless misinformation campaigns, they are being squeezed from formulations even in the face of data that proves their safety and usefulness.

Further, methylisothiazolinone (MIT) is to be banned from most leave-on products as the EU Cosmetics Directive is amended.8 Canada also appears to be making strides to remove MIT from formulations.8

Polyaminopropyl biguanide is another preservative that has officially been classified according to Article 15 (1) of Regulation (EC) No. 1223/2009 as carcinogenic, mutagenic and toxic to reproduction (CMR2).9 This classification took effect on Jan. 1, 2015, and prohibits the use of this material as a cosmetic ingredient.9 On a positive note, free-from claims are falling out of favor in the EU, and formal restrictions to their use may follow.

Siloxane Restrictions

In terms of environmental challenges, siloxanes have come front and center. Consumers benefit tremendously from the use of silicone-based hair conditioning ingredients, and formulators love them for their highly effective conditioning properties, stability and lack of reaction with other ingredients or oxygen.

However, Canada and more recently the EU have raised concerns about cyclotetrasiloxane (D4 siloxane or D4) and cyclopentasiloxane (D5 siloxane or D5), which have become ubiquitous and extremely important ingredients in the hair care industry. On Jan. 31, 2009, Environment Canada and Health Canada released a final “screening assessment” for D5.10 This assessment concluded this substance impacted the environment, and the ministers of health and the environment recommended the chemical be added to the Toxic Substances List of the Canadian Environmental Protection Act (CEPA).10

Affected industry stakeholders filed a notice of objection, reasoning that the assessment of D5 was not inclusive to the best available science and that the previous analysis relied heavily on models that had limitations and likely inaccuracies.10 The industry also designed and commissioned a scientific study that proved the environmental safety of these ingredients.

Eventually, Environment Canada reversed its decision under the new data from the independent study, which gave Canadian regulators comfort in terms of the environmental impact of D5 siloxane, although questions remain for D4 siloxane and its environmental impact. In the United States, the Cosmetic Ingredient Review Expert Panel concluded D4 to be safe for use as a cosmetic ingredient, and safe for its extensive function in hair products. This ingredient is still under question in the EU.11

Hair Growth Therapeutics

Male pattern baldness, alopecia and short, thin eyelashes are clear cases where individuals lack hair. These issues belong to the dietary supplement, drug and cosmetics industries, which is where things become complicated. Countless topical “cosmetic” products have been introduced to the market in the hopes of solving the need for more hair. Some are based on “natural” ingredients, which give marketers the false impression that can freely market them without regulatory oversight. However, if a topical product truly works to stimulate hair growth, there’s nothing cosmetic about it.

In 2011, the FDA made a point of enforcing regulations against products promoting eyelash growth, although the claims on a hair treatment product or mascara product—i.e., fuller, thicker hair/lashes and more hair/lashes—blur the drug/cosmetic line.12 It is at this interface where marketing departments and their regulatory and legal advisors spend a great deal of time.

Finally, no discussion of improving hair quality or quantity would be complete without recognizing the attempts marketers have made at orally ingested nutritional products, often referred to as Beauty from Within (BFW) or nutricosmetics. Aside from whether or not these products work, the regulatory oversight is complex and without a hint of global harmonization. In some jurisdictions, these products are regulated similarly to foods; in others, more like drugs. From the consumer’s perspective, these products have never really taken off. The speculation is that consumers do not immediately see or feel the benefit, and manufacturers see steep regulatory limitations.

Whether the consumer wants to rid themselves of hair, have more of it, or simply change their look, few segments of the beauty industry fall under a more complex scientific and regulatory landscape than hair care.

References

All websites accessed May 15, 2015.

  1. www.electrology.com/faqs-about-permanent-hair-removal/
  2. www.cancerresearchuk.org/cancer-info/cancerstats/types/bladder/riskfactors/bladder-cancer-risk-factors
  3. http://onlinelibrary.wiley.com/doi/10.1002/1097-0215(200002)9999:9999%3C::AID-IJC1092%3E3.0.CO;2-S/full
  4. www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/CentennialEditionofFDAConsumer/ucm093787.htm
  5. NE Estrin, The Cosmetic Industry: Scientific and Regulatory Foundations, CRC Press (1984)
  6. www.fda.gov/Cosmetics/Labeling/Regulations/ucm126438.htm
  7. www.margiepatlak.com/hair_dye.pdf
  8. www.medicaldaily.com/chemical-irritant-cosmetics-banned-europe-mit-leads-epidemic-skin-allergies-eczema-265379
  9. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_q_095.pdf
  10. http://ehsjournal.org/http:/ehsjournal.org/robert-fishlock/canada-environment-canada-reverses-siloxane-d5-decision/2011/
  11. www.cyclosiloxanes.org/uploads/Modules/Links/17.-cyclomethicones-final-cir-report.pdf
  12. www.adstandards.com/en/clearance/cosmetics/Guidelines-for-the-Nonprescription-and-Cosmetic-Industry.pdf

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