This guest post was submitted by Lisa A. Leigh, of Leigh Business Group, New York, NY.
Is the creativity behind cosmetic chemistry being stifled by excessive regulation? How can regulatory specialists and formulators in the personal care industry work together to develop innovative products that wow the marketplace but yet stay within the confines of the law? Can excessive regulation present unforeseen opportunities for formulators? These modern dilemmas are on the forefront of a rapidly-changing global regulatory landscape in the personal care industry.
Generally speaking, cosmetic formulators and regulatory specialists work closely together to bring products to market. But how can they work together to not only streamline the process but to also develop an ongoing creative compliance framework?
Cosmetic chemists work with the exterior of the body developing lotions, makeup, shampoos, over-the-counter drug products such as sunscreens and antiperspirants as well as other personal care products. A formulator may be an entrepreneur or may take a position in corporate R&D.
Regulatory specialists are the protectors of the businesses they work for by ensuring that the products are in compliance with federal, state and international laws where the company markets its goods.
It is smart business practice for regulatory specialists and formulators to join forces and make it their mission see to it that creativity is not stifled, regulations are met, and new global products launch smoothly.
Working with cosmetic regulatory specialists
Unfortunately, this is easier said that done because complex marketing plans, global supply chain distribution and aggressive launch strategies often collide with unexpected regulatory restraints causing costly delays potentially destroying an otherwise profitable product line. To avoid any kind of financial catastrophe, marketing objectives must be shared during the early product development cycle so that potential claims take into consideration current consumer perception and awareness. The marketing objectives must be followed up with a well-designed product safety review and testing protocol, both pre-and post market.
It is also essential that a global marketing plan takes into consideration different regional regulatory requirements for ingredient selection, product claims, advertising and promotions.
Changing cosmetic regulatory landscape
Aside from these obvious suggestions, there is more to the story. In the US, the cosmetics/personal care industry has seen an in-your-face visible rise in Non-Governmental Organizations (NGOs) or activist group campaigns that are spurring highly restrictive legislation on the industry.
Companies have no choice but to pay attention to the heated debates over controversial ingredients whether scientifically proven or just perceived by consumers to be harmful. Because of the wide success of these activist campaigns, consumers now fear ingredients such parabens that have been long-proven to be safe. No matter, businesses must accept that the marketplace is the final judge of product success and perception of risk by the consumer is inherently important in determining what a product is acceptable or not.
Activist groups have made it crystal clear that FDA guidelines are aging and may need to be re-upped in light of new technology, new products and growing consumer demands, not only in this country but also globally. Industry is aware of these flaws and has been proactive in instituting change. The Personal Care Product’s Council and the Safe Cosmetics Alliance have both announced their support for H.R. 4395, a bill introduced by Representative Leonard Lance known as the Cosmetic Safety Amendments Act of 2012.
Beyond Federal Cosmetic regulations
Unfortunately, it doesn’t stop with federal laws. California is an example of a state within the US that has generated legislation that goes far beyond FDA regulations via Prop 65, the Safe Cosmetics Act and now Green Chemistry.
In the area of regulatory affairs, it is important to have current information on the changing regulatory scene not just in the US, but in markedly different areas of the world. A manufacturer cannot just decide it wants to sell its products in any market because their competitors are going there. There are 193 countries in the world and each one of them has its own set of changing and evolving regulations that must be scrutinized and carefully followed. Some countries require product registration to import, some ban certain ingredients and some counties do not even allow products made by American companies. Because of the vast differences between global regulations, global harmonization is sought after but far from being realized. It can takes months and even years before a product can be sold in a particular foreign market.
Today FDA, COLIPA and other and regulatory bodies around the globe are going through a revolution. They are putting certain restrictions on chemical ingredients like formaldehyde, dibutyl phthalate, parabens and many others once proved safe.
Working with regulatory experts
Regulatory experts need to work closely with formulators to relay new regulatory information so that they understand the parameters under which they may develop a new formula, not just for the US but for global markets. Each country, industry organization, manufacturing company are impacted by present and anticipated regulation.
The EU’s REACH program and new Cosmetic Directive 76/768/EEC recast as Regulation (EC) No 1223/2009 have an escalating impact on the safety, formulation and commercialization of both old and new products all over the world. EU’s REACH has already spurred many other countries to introduce their own versions. Legislation in one part of the world is likely to be copied in other parts.
For complicated, radical legislation like REACH, regulatory specialists must communicate to formulators product/ingredient assessment requirements such as product definition, supply chain restrictions, registration requirements, substance composition, data sharing, testing, and even environmental effects.
Is it a cosmetic?
Aside from these aggressive chemical regulations, regulators must keep formulators in the loop as to whether a new product is actually a cosmetic or a drug. For example, Australia, the US, EU, Canada and Japan have varied definitions of sunscreens and antiperspirants. In Japan, a sunscreen may be considered a Quasi Drug, but in Korea it may be a functional cosmetic. In the EU, anti-aging products or cosmeceuticals are considered “borderline” products meaning they straddle the line between cosmetics and drugs. Because of this lack of global harmonization, two or three different formulas of the same product may need to be developed. Even though industry has worked for years to harmonize global regulations, it is years or even decades away from realizing one universal standard.
Additionally, when moving into global markets, regulatory specialists must communicate to formulators if certain ingredients pose a particular risk. Some plant-based extracts or botanicals which are popular in natural, organic cosmetics are known to have potentially adverse effects or can cause allergies. Allergens in fragrances containing essential oils and plant extracts are particularly under attack in the EU.
Launching a cosmetic
Whether introducing products for sale in the US or internationally, it is important to define solid testing protocols and develop claims that hold up under scrutiny when dealing with non-harmonized regulatory environments. Allowable ingredients and percentages must be known as well as what borderline product claims will be acceptable in a variety of markets. How to evaluate claims for various ingredients must be conveyed. As well as whether the claims are based on literature, in vitro data or ingredient based or finished formulas. What are the various methods to scientifically support specific claims as well as whether a supplier’s ingredient claims be evaluated and reused must be answered decisively.
Every compliance plan should address issues such as: 1) what info do you have and what is missing that you need; 2) any additional education, training and preparation of formulation requirements needed; 3) compliance management systems for tracking and tracing registration 4) whether additional test data is a must; 4) what are the market risk factors, and 5) how communication internally and externally up and down the supply chain will be conducted.
Preparing for compliance
Being prepared with a solid creative compliance plan can prevent costly product launch delays and other financial setbacks as well as wasting time spent for formulators to work on new products, ingredients and processes that can turn into valuable intellectual property such as patents and trade secrets.
Every high volume company knows that its intellectual property is considered to be a key component of success and in its future. Failure to produce and protect intellectual property assets may spell the difference between the success and failure of a business entity which is why it is important that US federal, state and international laws do not get in the way of innovation. Regulatory specialists must be vigilant in communicating to formulators and marketers new regulations and already have a sound compliance plan in place that provides formulators with the knowledge to work in a creative, positive and non-restrictive environment.
Unfairly, the cosmetic/personal care industry is being scrutinized and regulated in much more detail than food, paint and household chemicals. Expect to see the passage of more legislation with a democratic Senate and re-elected democratic president.
Each country, industry organization and manufacturing company of both ingredients and fully formulated products are being impacted by current and anticipated regulation. The standards have been raised from a regulatory and consumer concern perspective. For the entrepreneurial formulator, the impact of a highly-regulated industry may result in the loss of business because they cannot afford the costs associated with such punitive regulations.
Creative regulatory compliance
Each company that sells cosmetics must assess which specific standards apply to its products and what it must do to ensure that it is fully compliant with global existing and emerging legislation. A creative compliance program must be in place to allow for the continued inspired innovation that our industry stands for and deserves.
If you are looking for regulatory help or advice for your cosmetic product launch, you can contact Lisa through her cosmetic regulatory website.