Nutrasource Blog

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:

Clinical research has become a fundamental step in the development of a dietary supplement. Nutraceutical companies are investing more in clinical research than ever before to support health and marketing claims and gain a competitive advantage in a saturated marketplace.

You have an exciting new product idea and are ready to take the leap and go to market. Before you start selling, however, it is important to make sure your product is the best it can be from a regulatory standpoint.

As competition in the food and health product space grows, companies frequently look to health claims to differentiate their products from those of competitors.  Claims that showcase the health and nutritional benefits of a product, while communicating the brand’s values and positioning to the end consumer, can help boost sales when done effectively.  Health claims appear not just on product labels but in all avenues of product marketing and advertising, including company websites, product pages and social media accounts.

Bringing a product to the next level can be a challenge.  There are many hurdles standing in the way, whether your goal is to support a new claim or re-position your product for a new market.

We've rounded up some of the most common questions we hear from the dietary supplement industry in the hopes that our answers will help you overcome your latest product development challenge.

The verdict is in on one of the two high-profile dietary supplement industry cases before the courts this year.  The decision from the U.S. Court of Appeals for the D.C. Circuit upheld the Federal Trade Commission's (FTC) charges that POM Wonderful and POMx ads were deceptive.  The ads claimed that the product could treat, prevent or reduce the risk of heart disease and prostate cancer, but lacked clinical evidence to substantiate such claims.

The decision led to questions around how much clinical evidence is required to support a health claim. How is a company promoting the benefits of natural health products supposed to navigate the regulatory landscape when even the guidances are not clear?