GRAS is an acronym for Generally Recognized as Safe. GRAS status is a regulatory designation first introduced by the U.S. Food and Drug Administration (FDA) as part of the 1985 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act). Its purpose was to exempt certain food ingredients from the definition of food additive.
Nutrasource Blog
An Introduction to Generally Recognized as Safe (GRAS) Filings for Food Ingredients
Posted by Dr. Robert McQuate, Ph.D., Chief Regulatory Officer - GRAS Associates on Thu, May 14, 2015
Tags: Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products
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.
Tags: Claims, Regulatory
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.
Tags: Product Testing & Certifications, Clinical Trials, Claims, Regulatory, Dietary Supplements/Natural Health Products
Can Your Dietary Supplement Claims Stand Up to the FTC?
Posted by Josh Baisley, B.Sc., Vice President, Clinical Design & Delivery on Fri, Feb 06, 2015
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?
Tags: Product Marketing, Clinical Trials, Claims, Dietary Supplements/Natural Health Products
How to Choose an Analytical Testing Lab for Dietary Supplements
Posted by Nutrasource on Mon, Jan 26, 2015
You are in charge of managing outsourcing for your company and you need to contract an accredited third party laboratory to provide analytical services to support your company’s analytical development. Which lab do you choose, and how do you select the right one out of the thousands of labs available?
The optimal selection of your analytical partner is an essential element to the overall strategy of your business. You are choosing a partner that can not only have significant financial implications for your company but may also affect your company’s reputation and how it is perceived in the marketplace.
Here at Nutrasource, we field many inquiries about stability storage testing for different dosage forms. To provide you with insight into this important but often overlooked type of product testing, our analytical team provides answers to frequently asked questions about stability storage and testing.
The Value of Third-Party Certifications for the Natural Health Industry
Posted by Jennifer Andrews, M.Sc., MBA, Marketing Director on Tue, Aug 12, 2014
Consumer interest in quality, transparency, traceability and labelling has grown substantially in the past decade. According to the Supplements/OTC/Rx (SORD) database, an ongoing market research platform launched in 2006, 44% of consumers are concerned about supplement quality.
Tags: Product Testing & Certifications, Product Marketing, Dietary Supplements/Natural Health Products
5 Questions to Ask When Navigating the Regulatory Pathway
Posted by William Rowe on Tue, Jun 04, 2013
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Navigating the regulatory pathway for products remains a challenge for many companies. Regardless of product sector (pharmaceutical, food and beverage, natural health product, cosmetic), the key five questions remain the same.
Tags: Claims, Regulatory, Concept to Claim