The first steps when developing any health and wellness product is to know first, what it is and second, how its regulated and in each target market as categorization may differ between regions. Many factors are taken under consideration when determining product classification as summarized in the figure below.
Starting with the end in mind
|Budget, timelines, and pressure to be innovative are just a few of the barriers that many companies face when looking to gain market access. The trick is knowing what you want to say about your product, what you can say, and having a clear understanding of the marketplace you’re looking to penetrate. From there, a strategic solution can be developed to assist in achieving your goals.|
Developing dietary supplements with strong claims not only allows brands to stand out from the pack but also provides a competitive advantage.
The current pandemic situation highlights a weakness in our traditional approach to clinical trials. You are probably experiencing some form of lock-down (“stay at home order” by your local or national government). Our innate sense of optimism says this crisis will blow over fast, but there are also dark clouds suggesting weeks may turn to months and true return to normality will take longer than we dare to think.
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”.
Cannabis has taken Canada by storm since legalizing recreational use in October 2018, and the highly anticipated second wave of regulations has finally arrived. Cannabis edibles, extracts, and topical products will hit the shelves mid-December 2019, and consumers and companies alike are buzzing with anticipation.
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.
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?
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.