Guest article

Regulatory Affairs: Your critical partner in innovation and business growth

By Elena Nekrasov, PhD, Senior Regulatory Scientist, Access Business Group, Amway

- Last updated on GMT

© Getty Images / magical_light
© Getty Images / magical_light
Getting your regulatory affairs department or a consultant involved early in the development process can save multiple headaches later when bringing new products to market. The global regulatory goalposts are moving all the time, and R&D teams need the latest information to keep pace.

Consumers’ health focus has shifted from avoiding malnutrition and filling nutrient gaps to health promotion, enhancement of physical performance, and avoiding chronic disease. To meet these new needs, the nutrition industry has had to undergo a transformation to identify innovative solutions to grow their business.

At the same time, albeit at a slower pace, regulatory agencies around the world are gradually catching up to emerging scientific developments and supply chain challenges, changing consumer demands and the new types of food products surfacing in the marketplace.  As a result, we’ve seen many regulatory changes around the world with stricter requirements and increased enforcement around food safety and claims. 

Moreover, we live in an e-commerce world with blurring borders and easy access to information, enabling quick access to multiple markets. For industry these changes have increased the burden of compliance with additional regulatory and transparency requirements around the world. These regulatory developments make it increasingly challenging to commercialize innovation and to effectively communicate it to consumers. This is when the right and timely regulatory expertise​ becomes critical for business success. 

Key take-aways:

  • The Regulatory Affairs function in the nutrition industry is no longer restricted to “a compliance-only” role and is becoming more critical for companies’ growth and success.
  • Early partnership with Regulatory Affairs is an essential component to ensure innovation will bring a return on investment.
  • Insufficient regulatory expertise and lack of awareness of the need to involve regulatory experts early in the ideation and development process persists in the industry, resulting in missed opportunities, costly delays and wasted resources.  

Nevertheless, in many nutrition companies we have yet to see an early partnership with Regulatory Affairs put into practice. Partnership with the regulatory function—whether via an internal department or by consulting with an outside professional—in early the innovation stages is a norm for other industries, such as pharmaceutical and biotechnology, but surprisingly it is still an after-thought in the food and supplement industry. Many companies and ingredient suppliers are unaware of or unable to keep up with all the regulatory developments (especially globally) and decide to move ahead uninformed, hoping the “regulatory issues” will somehow get resolved. 

This approach may work in the short-term, but it is not suitable for sustained business growth and successful commercialization of innovation. The so-called “regulatory issues” do not go away and only become more prominent, growing in number and impact. If not taken into consideration from the start, these will cause innovation to be at best delayed, at worst scrapped all together or attract negative attention from government agencies. 

Pitfalls of neglecting early regulatory input

If you were to ask any seasoned regulatory professional in the industry you’d find that regulations have become more, not less complex; regulatory change is more, not less frequent; and regulatory compliance, especially for global companies, has become more challenging and costly. Below are some hypothetical examples of common misses due to lack of appropriate and timely regulatory input.

Example 1:​ A supplier claims their ingredient meets the definition of “natural flavor” but does not disclose that it is actually meeting the legal definition of “natural flavor” in the US only. Product Development spends 18 months of time and resources to develop a product with an optimized sensory profile, anticipating a global launch. A month prior to the launch date the company learns that the flavor cannot be labelled as “natural” in markets outside of the US. As a result, they must reformulate and find an alternative flavor.

Example 2:​ In 2009 CODEX adopted a fiber definition related to physiological benefit. Yet most fiber-suppliers ignored this important standard. Then, in 2017, after the US FDA issued guidance on a fiber definition similar to that from CODEX, suppliers and manufacturers scrambled to comply. This resulted in extra work and fiber-product reformulation out of fear that the old fiber ingredients would not be able to meet the new definition.

Example 3​: A company developed a product with added anhydrous caffeine for the US with the intention to expand it to new markets. However, use of synthetic caffeine as a food ingredient is not allowed in some countries. Now the product will have to be redesigned using a natural source of caffeine, like green tea extract, which will affect the final product cost and require a new sourcing strategy.

Example 4:​ Your product contains corn starch from GMO-corn. Although starch is highly processed and contains minimal residual GMO levels, this product will need to disclose GMO-contents in labelling in some markets, which may turn away certain consumers. 

Speed to market advantages

Having an innovation culture that views the regulatory function as an inherently collaborative enterprise and that recognizes the need for early partnership would improve innovation speed-to-market, reduce waste of resources and support sustainable business growth.  Understandably, innovation in the industry setting has multiple objectives, like “finding IP space” or “new growth opportunities”, but everyone can agree that the core business value of innovation is identifying new products that can be successfully commercialized. C​ompanies that are truly invested in innovation will involve the right regulatory expertise​ from the start. 

Early partnership with knowledgeable and open-minded regulatory professionals who are passionate for your business is a critical factor that enables innovation rather than stifling it. They will help you to navigate through regulatory maze and guide your innovation to reduce waste of resources and enable quick market access.

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