Nutrasource Blog

Sports Nutrition as a business category within foods and dietary supplements have had a relatively short history. From a mass market perspective, it was not until 1965 and into the 1970’s that the nephrologist (kidney specialist) Robert Cade, MD started tinkering with a “homemade” beverage, later named Gatorade (Dr. Cade was the Director of the Renal Division at the University of Florida Medical School) for the sole purpose of helping football players stay hydrated during the hot and humid game conditions in Florida.

As we are all adjusting to modifying our work practices to stay safe and “flatten the curve” during the time of COVID-19, work must go on. R&D, product development, and regulatory compliance are as important as ever as the FDA has been handing out warning letters for unsubstantiated coronavirus claims.

Medical Foods is a unique regulatory category wedged between supplements and drugs, a category where nutrients can be marketed with a claim for the management of a disease. A claim that has led some to call this category “supplements on steroids”.

How has the probiotics market evolved over the last 12 months?

We have seen some interesting market shifts over the past 12 months. A small pull back on market growth in the US, probably fueled by a combination of education gaps at the HCP and consumer level and too many copycat products in the market. Then in APAC, that market is starting to experience exponential growth. Where in Europe we are starting to see a small comeback in the supplement market. So varying situations which are region specific, just like the regulatory environments around the globe.

The Western world is hungry for health products, and industry is meeting that demand with increased product innovation and global expansion like never before. In Canada, consumer health products are categorized as foods, drugs, cosmetics, and natural health products (NHPs). NHPs (referred to as dietary supplements in the U.S.) are health products sold in traditional medicinal formats. Vitamins and minerals, protein powders, herbal medicines, probiotics, and many others, are all examples of products that are sold as NHPs. A 2010 survey showed that 73% of Canadians consume NHPs regularly, proving Canadian consumers are more interested in alternative health products than ever before.

It’s no secret that probiotics are dominating the supplement market, and the consumer demand for foods and supplements that contain beneficial bacteria is increasing exponentially. In fact, the probiotics market is predicted to be worth $69.3 billion by the year 2023.

As the cannabidiol (CBD) market continues to gain steam, global regulators are working to carve out or update legal pathways to market. This makes keeping up—and staying compliant—an ongoing challenge for brands.

What if you could develop one dietary supplement, with a single product specification, and sell it in multiple countries simultaneously – with no reformulation or regulatory headaches involved?

Note: This article pertains to the United States. Products sold elsewhere are subject to different country/region-specific regulations.

Mandatory label compliance deadlines are drawing near. If you sell, or are planning on selling, a dietary supplement or food in the U.S., here is what you need to know about the updates required and how you can comply.

In addition to the changes to nutrition labeling, due for most companies January 1, 2020, FDA has set an official “uniform compliance date” of January 1, 2022 for final food and dietary supplement label regulations issued in 2019 and 2020. This compliance date also applies to the National Bioengineered Food Disclosure Standard.

With so many label updates coming in the near future, will your brand ready?

For the past decade, I've written and educated industry about the benefits of substantiating dietary supplement claims, from the rationale of complying with national regulatory rules to remaining ahead of the innovation curve.

But despite policing from the U.S.-FDA and FTC, and the negative media attention surrounding offending brands, the supplement industry still has a substantiation problem. There are far too many instances of companies under fire (or yet to be under fire) for unsubstantiated, misleading, or deceptive claims.

The good news is that this can be fixed with a clearer understanding of what qualifies as substantiation and how companies can benefit from making the investment in quality research. Read on to find out what you need to know.