The excitement about dietary supplements keeps growing more than ever as they expand their reach to new market levels across the globe. Recent industry efforts to curtail regulatory challenges along with the rapid rise of personalized nutrition in the form of medical foods are changing the dynamics in a highly competitive marketplace. What do these developments mean for the consumer? How do these trends impact the dietary supplement industry?
Supporting evidence-based claims has become more challenging as regulators seek science behind claim specifications. The review of dossiers promoting health claims by function carried out by the European Food Safety Agency (EFSA) have toned down the marketing of health claim benefits of dietary supplements in Europe. It does not mean that supplements cannot be sold; rather they cannot make certain claims if not approved by EFSA. The United States follows a more flexible approach on health claims, yet the threat of increased regulatory action is not going away. The intention is not to expand pre-market regulation as it would be costly for both producers and regulators; rather the goal is to have players meet current regulatory standards so as to avoid further regulation in the future.
Revisiting some of the important issues on safety, efficacy and quality discussed at the Council For Responsible Nutrition (CRN) conference back in September 2013, we see that progress has been made in terms of realigning the industry through the efforts of a cohesive group of firms seeking to balance the access to safe and efficacious supplements against the threats of increasing regulatory activity. It is clear that the target of the industry is to produce and market supplements that can guarantee a health benefit to consumers, while impeding impostor of illegal firms to improperly benefit from this effort by selling tainted supplements or questionable products. In the most recent examples of this progress, the Food and Drug Administration (FDA) in the US published two guidance papers “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements” in January 2014 that address some of the issues and concerns raised by the dietary supplement industry. Both guidance papers aim to provide clarity on the labelling, packaging, composition, serving, size, recommended daily intake and directions of use of supplements. In another great example of progress, the Designer Anabolic Steroid Control Act of 2014 (DASCA) was introduced to Congress on 11 February 2014 in the US to ban the use of designer anabolic steroids in dietary supplements and sports nutrition. One of the topics and main concerns addressed at CRN’s conference was the illegal use of designer anabolic steroids and how they are exposing consumers to unnecessary health risks while tainting the image of the industry.
In separate interesting development, medical foods are encountering further scrutiny as in the past they did not have to meet the same regulatory constraints as those set for dietary supplements. In theory, medical foods are enteral formulations that treat specific nutritional gaps of people diagnosed and suffering from a medical condition that cannot be treated by modifications in the diet and that requires the supervision by a health professional. Sales of medical foods may not necessarily need a prescription for dispensing, but sometimes need to take place through the institutional channel. Medical claims are usually allowed in these foods as opposed to dietary supplements that require evidence-based support to make claims on the label. The apparent open concept or grey area of “medical food” has been adopted by some smaller firms as a good opportunity to sell nutritional supplements labelled as “medical foods” and carrying medical claims without having to meet the regulatory burden of what dietary supplements and drugs go through nowadays. The FDA published “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition” that closed for comments on December 2013. This specific guidance aims to provide more clarity on the definition of medical foods by making sure that certain conditions such as pregnancy and diabetes are not labelled as medical foods, while others such as inborn errors of metabolism (IEMs) would fit the medical food definition. In the past, EFSA established the directive of “foods for special medical purposes” (FSMPs) under the Foods for Particular Nutritional Uses Directive 2009/39/EC (an amendment of Directive 1999/21/EC) within similar parameters of those of the FDA. Several big players in medical foods such as Danone (Nutricia), Unilever, Nestlé Health Science (Pamlab, Vitaflo, Prometheus Labs, Accera Inc partnership), Abbott Laboratories, Ajinomoto, and other biotech firms such as Targeted Medical Pharma and Mondobiotech have rushed to file many patents for medical foods based on genomics and personalized medicine that will drive future growth for medical foods, especially as the global population ages. This innovative approach will help them set apart from standard dietary supplements or functional foods targeted at healthy people.
In spite of the rising calls by many health organizations to have people meet their nutritional gaps via fresh, functional or fortified foods and beverages against the irresponsible intake of dietary supplements, bright prospects of growth persist for the sales of dietary supplements needed to help fill nutritional gaps in healthy people who do not need medical foods, or who may not meet their daily nutrient requirements. Amongst them, protein supplements, minerals, probiotics and fish oils/omega fatty acids will likely remain the top performers as evidence continues to prove that they indeed may help people prevent certain chronic conditions and maintain their health. Their combined global retail value was estimated at US$18.4 billion in 2013, while they are expected to generate a total of US$24.7 billion by 2020. This is an impressive growth of 34% that will make a positive difference in the health of millions of consumers.