What regulations impact personalized nutrition?
Personalized nutrition presents exciting commercial avenues for food, beverage, and supplement companies to explore. However, innovators in this space need to be mindful of regulations that could limit the scope of new products and services. Many approaches to personalized nutrition are reliant on advanced data analytics and techniques such as artificial intelligence (AI). So, the regulatory landscape extends beyond that for traditional foods, beverages, and supplements.
The EU and US regulatory landscapes
In the EU, five key regulations may apply to personalized nutrition products and services. Compliance with general principles and requirements for food safety and consumer protection, as set out in the General Food Law Regulation (EC 178/2022), is just the start. Any health claims must be supported by scientific evidence and approved by the European Food Safety Authority (EFSA) under the Nutrition and Health Claims Regulation (EU 1924/2006). And personalized nutrition products that contain novel ingredients or use novel technologies, such as genetic testing or AI, may be subject to the Novel Food Regulation (EU 2015/2283). As personal data is the foundation of many personalized nutrition strategies, GDPR (EU 2016/679) compliance is another priority. Finally, personalized nutrition products or services that involve wearable devices or diagnostic tests may come under the jurisdiction of the Medical Devices Regulation (EU 2017/745).
In the US, personalized nutrition products and services are subject to general regulations governing the safety and labelling of dietary supplements, functional foods, and medical foods. Like in the EU, the regulatory framework is somewhat fragmented.
Dietary supplements are regulated by the US Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Functional foods which provide additional benefits beyond basic nutrition and may contain added bioactive compounds are governed by FDA under the Federal Food Drug and Cosmetic Act. As with the EU, data protection is an important consideration. So, personalized nutrition providers should consult the Health Insurance and Portability and Accountability Act of 1995 (HIPPA).
Defining personalized nutrition
At present, there is no single globally accepted definition of personalized nutrition. This is not unusual for a field in the early stages of development, but it can result in a lack of clarity for product development, marketing, and regulatory activity. The International Society of Nutrigenetics/Nutrigenomics (ISNN) defines personalized nutrition as “the development of nutritional recommendations and interventions that are tailored to an individual’s genetic, metabolic, phenotypic, and/or psychosocial characteristics, with the aim of improving health and preventing or treating disease”. While other definitions may vary from this, the general emphasis is on providing targeted and individualized nutrition advice intervention with potentially more positive and relatable health outcomes.
A growing category
Significant growth is expected in personalized nutrition over the coming years. According to a Grand View Research report, the global personalized nutrition market was valued at USD 43.40 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 15% from 2023 to 2030. The report cites factors such as increasing prevalence of lifestyle diseases, growing consumer awareness of personalized nutrition and advances in technology and analytics as driving market growth.
To make the most of this potentially lucrative market, it pays to leverage regulatory insight during the front-end innovation phase. Find out how our regulatory review services can help you anticipate and overcome barriers to market entry here.