Nutrasource Blog

Summary: FDA announces draft guidance for industry on their policy to exercise enforcement discretion on delinquent notifications to encourage firms to submit NDIN to correct past failures. Read on to learn more.

By the end of this blog post, you should have a good understanding of who regulates supplements in the US and Canada, and how they differ from food and drug regulations. Continue reading if you are looking for information on how to sell supplements in Canada or the US. Understanding the category definitions as laid out by the respective regulation is one way to discern between frameworks; see table below.

Increasingly, over the past few years, the dietary supplement industry has emphasized quality control and claim substantiation. At times, companies conserve on quality control and can end up with a product that doesn't match the claims and ingredients on the label. Many look to third-party organizations that help solve this problem by objectively certifying supplements for purity, safety, and quality. Non-GMO certification has become an useful tool to address some of these concerns. Keep reading to learn more about consumer demand for third-party tested products and ingredients and learn more about the Non-GMO certification process.

Consumers today are far more educated and discerning in their choice of dietary supplements. For context, one in five of US consumers make a transparent vitamin and supplement brand their first choice, according to a consumer market research study, as they seek transparency and third-party certification to back up their claims. Outlined in the 2021 TTC ITC Insights Consumer Supplement User survey, 31% of consumers consider quality certifications and seals on labels/ website a key driver of trust.

This goes beyond consumers, when healthcare practitioners were surveyed, over half of the dietitians surveyed considered quality certifications and seals displayed as the number one driver of trust. 

Needless to say, having third-party certifications back your claims is critical both for consumer consumption and healthcare practitional referral of product. As mentioned, one area that leading dietary supplement brands have leveraged is third-party certifications related to Non-GMO testing. Not only are consumers looking for Non-GMO tested products and ingredients, many retailers require a brand to have third-party certification validating their Non-GMO claims.

Making a Non-GMO claim through traditional supply chain verification is impossible for some ingredients. Certifications by Nutrasource has a streamlined and effective process that assists your product and/or ingredient in acheiving these certifications.

Below we address some of the common questions we receive related to Non-GMO testing and certification.

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.

You've developed a new product and are keen to market it as a dietary supplement in the U.S. You're confident it fulfills the FDA's definition, but its "star" ingredient is newer to the market and, to your knowledge, hasn't been used in foods to date. This means that if you marketed it as is, the product would be considered adulterated.

What options do you have to go to market, and what is the most effective way to do so without raising regulatory red flags and risking your brand reputation?

Sesame has recently been added to the list of major food allergens, here's what you need to know for product labelling.

Developing dietary supplements with strong claims not only allows brands to stand out from the pack but also provides a competitive advantage.

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”.