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.
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: The regulatory information provided in this article pertains to the United States.
If you have been following recent CBD (cannabidiol) discussions happening around the world, you'll know that the evolving regulatory landscape is leaving many brands confused about their market access options.
As regulatory consultants, we field questions daily about CBD compliance and marketing, both from food and supplement brands and CBD suppliers looking to get to market quickly.
To help you find an efficient pathway to market, we've put together a list of frequently asked questions about CBD marketing, sales, and compliance—including GRAS—for the U.S. market. Read on for answers, then get in touch with us to discuss options specific to your company's needs and objectives.
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.
The past year was a whirlwind of regulatory change that brought exciting opportunities and new challenges in equal measure.
As we look to another game-changing year ahead, our regulatory and scientific team reviews the top regulatory trends expected to shape health product innovation and marketing in 2019 and beyond.
Here's what to expect...
While many U.S. states (and, of course, Canada) are approving medical and recreational use of cannabis products, confusion about how these products are regulated continues to grow.
When Congress passed the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a unique marketing position. Unlike prescription drugs, which must be rigorously tested to prove both safety and efficacy before they are approved by the Food and Drug Administration (FDA) for commercial release, dietary supplements can go to market immediately. The FDA monitors the “claim” to ensure there is no implied cure wording and the Federal Trade Commission (FTC) assesses the truthfulness of the label claim only if there is a complaint.
Product claims are a key component of dietary supplement positioning and marketing. Companies use claims to showcase their product's health effects, nutritional benefits or performance to reinforce brand values and help boost sales.
Substantiating product claims is an important aspect of any product launch or
repositioning strategy. Not having the right type or level of data required to support a
claim can put a brand at risk for regulatory consequences, negative publicity and,
ultimately, a loss of market share and competitive advantage.
Below are five essential tips and best practices from our Dietary Supplement Claims Substantiation E-Book which you can use to develop an effective claims strategy for your dietary supplement:
There are many questions that must be asked, and consecutive steps planned, in order to successfully develop and launch a dietary supplement. These questions include: