Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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44 INSIDER September/October 2017 The word "substantiation" carries a lot of weight. In fact, substantiation itself is an action, and the word is a verb. An action verb. Therefore, we also can think of the word substantiation to be proactive versus being reactive. The defi nition of substantiation includes three aspects, and of which underscore why this is so important of those who do business in the nutrition sector. (Although, one can argue, this is just as important for anyone who sells something in general or other commerce.) Before we defi ne substantiation, it is also good to know that the general term originated in the mid-1600s from the Latin word, substantiātus. Substantiation is essentially defi ned three ways: to establish by proof or competent evidence to give substantial existence to to affi rm as having substance; give body to; strengthen Substantiation also can be thought as the backbone off of which a company bases its advertising and marketing. In the United States, under FTC and now even state laws, one must have what is believed to be competent and reliable evidence to support an overt marketing claim or inferred claim. While most people understand substantiation through its literal defi nition, FTC published (way back in 1972) what are popularly known as the "Pfi zer Factors." These factors helped to defi ne how the agency viewed advertising and marketing as related to the product and potential impact on consumers. The Pfi zer Factors are what also, in general, helps FTC decide if there is a reasonable basis for a claim. The Pfi zer Factors are: 1 the type of product, 2 the type of claim, 3 the benefi t of a truthful claim, 4 the ease of developing substantiation for the claim, 5 the consequences of a false claim, and 6 the amount of substantiation experts in the fi eld would consider reasonable. FDA and FTC work together, when appropriate, on "policing" the industry. This includes reviewing labels for claims, implied claims and substantiation. In 2008, FDA attempted to further defi ne substantiation by releasing a well-read guidance document. In fact, FDA basically stated it views the following four parameters as the foundations of substantiation: 1 the meaning of the claim(s) being made; 2 the relationship of the evidence to the claim; 3 the quality of the evidence; and 4 the totality of the evidence. FDA's guidance document attempted to further the understanding of what substantiation is by sharing examples that are typical in the supplement industry. Defi ning what level of substantiation is adequate has become an issue that companies that want to be proactive are grappling with, considering the various takeaways from FDA's and FTC's outreach to industry, as well as outcomes from litigation brought by FTC and other parties against natural products companies. A successful business is one that generally minimizes its risks, while also making sure it runs effi ciently. One way for a company to be effi cient, cost-conscious and smart, especially if the company markets aggressively, is for it to have a substantiation assessment done prior to the product launch. This is sometimes called a "CARSE" assessment. In other words, one can prevent legal issues upfront by creating a live dossier that covers why a product and related claims are based on competent and reliable scientifi c evidence (CARSE). Several things must be considered before assessing the basis for an implied or direct claims. First, one published ingredient study may not be enough for a reasonable basis for a product claim. Does a company need studies at all if it has content area experts who "endorse" the claims as being reasonable? What happens if the company is challenged on the quality of the data that it relied on for its marketing and advertising? What about the cost of creating or obtaining substantiation, can the company predetermine what it might cost versus what legal issues may cost you? And, is it acceptable to look for substantiation after it has been hit with an FTC issue or civil lawsuit? Substantiation defi nitely is a verb, as it is about action. Douglas Kalman, Ph.D., R.D., is a research scientist at QPS (, a contract research organization that conducts clinical trials in the pharmaceutical, medical device and nutrition industries. In addition, Dr. Kalman is with Substantiation Sciences (, a consultancy that helps companies realize their intellectual property (IP) and marketing substantiation goals. Substantiation—It Matters by Douglas Kalman, Ph.D., RD Sports Nutrition Hear more about substantiation from Douglas Kalman during the "Exploring the Opportunities, Challenges in the Sports Nutrition Space" Workshop on Tuesday, Sept. 26 at 1:30 p.m. at SupplySide Wes t in Las Vegas. The session is underwritten by Arranti, Nutrition 21, Pharma Foods Int'l., Shanghai Freemen and XSTO. Scan Here Sports Nutrition at SupplySide West

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