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Well-designed clinical trials on ingredients and finished products should create the foundation for marketing to consumers.
March 1, 2013
By: Douglas Kalman
PhD, MS, RD, CCRC, FACN, Miami Research Associates
Is anyone really surprised anymore when they learn there’s a man behind the curtain, and that there’s no mystical, all-knowing, all-powerful being named “Oz?” If you have never seen the film “The Wizard of Oz” I highly recommend it, not only for history’s sake—and to see the late, great Judy Garland—but also for understanding how marketing influences thoughts and actions. The use of marketing via impressions intrigues me. When hearing the name “Oz” today, most Americans think of the famous television personality Dr. Mehmet Oz. While I believe he is a wonderful physician, and a very bright and influential man, he seems spread too thin. It’s difficult to master every discipline, so every now and then it seems, perhaps, he is fed information—unaware of exactly what he’s discussing. But let’s not get off track. Does science come before marketing? Yes, we know that it should, or it’s supposed to. However, when talking with various executives who work in the nutritional products industry, it seems that sometimes a decision regarding a product or a product in development is made to create a platform on which they want to market that product—before they find the science to substantiate the product. After hearing this notion, I wondered, do many companies or industries identify what is perceived to be a need (or opportunity) first, and then decide to develop a product based on that opportunity? Or do companies develop a product first and then decide how to develop the market for the product? One aspect of bridging product creation with marketing is to define the category that one seeks to enter. Take, for example, Champion Nutrition’s new product line that is based on ambition. The products are intended for individuals in a pre-defined category who are looking to achieve a sports nutrition goal. For example, if you lift weights and want to get stronger, then the product “Strength” would be the right fit for you. Forrest Haag, brand manager, Champion Nutrition, was quoted as saying, “The beauty of this line is we are ambition focused. It’s all about where you want to go.” This seems like it could be a case of creating a product to fit a segment of the community that has similar goals. In this case, the ambition is gaining strength, so the marketing will probably be directed toward those who lift weights and are looking to get stronger. If a company is going to utilize an “ambition-focused” marketing and product development approach, what type of science must be in the arsenal to support the product? The answer lies within what the company wants to say about the product in conveying the intended use to the public. Is the name of a product alone an implied claim? For example, does calling a product “Slim” denote or imply that the product could help one get thinner or slimmer? If the answer is yes, then at least one or two well-designed, randomized, double-blind and adequately powered clinical trials are needed to support claims, according to the Federal Trade Commission (FTC), U.S. courts and recent rulings. Other levels of scientific support for implied or overt claims have been considered adequate, however, the point is that scientific support for any form of marketing, whether it be ambition-based or direct, needs some form of substantiation in order to be considered legitimate. Mr. Haag conceded that the company does not currently have any finished product clinical trials to support claims, but also noted that studies are in the planning stages. Those who fail to plan, plan to fail. So it would be great to see these studies engaged and carried out in an objective, third-party manner before claims are made on a product. Since that was not done in the case of these protein-based products, hopefully these studies will be carried out early in 2013. I contend that the product development cycle is strongest when it includes original research on key ingredients and/or finished products before the products are released to the public. The research is most convincing when carried out by a third party and conducted under Institutional Review Board auspices utilizing FDA Good Clinical Practice standards. Companies that utilize prospective research rather than Googling or searching Pubmed (www.pubmed.gov) can also gain an advantage over competitors. This advantage includes first-hand knowledge of how the product performs for the user, the potential for patents (intellectual property) and the right to utilize the research in conversing with the public about the product. If you choose to utilize already published science available in the public domain, and the data is not that special, any company selling the same ingredient or product may argue it is “borrowed-science.” However, if it is your science (your study) on your product, then the information is unique and can be protected from anyone else using it for their economic gain (and your loss of opportunity). FTC guidelines for advertising in the dietary supplement industry, along with with recent rulings by FTC and U.S. courts, indicate a preference for product claim substantiation through actual clinical studies (trials) that are well-designed, adequately powered and prospective in nature. From a regulatory perspective, science supporting a product should come before decisions regarding how that product will be marketed. Recall that the marketing of a product often draws the ire of class action lawyers, civil litigation and regulatory actions. The FTC denoted that “before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.” To me, this also implies that the science should be completed, vetted out and secured before marketing a product. It is imperative for the legitimacy of the nutrition industry to utilize science—especially prospective science, as opposed to borrowed science—in an effort to drive product development and product validation and to create sound messages to the end-user. The growth of clinically tested ingredients and finished products helps enhance the legitimacy of the entire industry. Marrying the product development cycle with ongoing science—both in-house and outsourced—can be done for less money than many think. The smart and judicious use of federal and state tax credits for R&D along with filing intellectual property will actually enhance the valuation of a company while also building a positive image for both the company and the brand. There are some intangible benefits when utilizing a science-first approach to product development and creation. Often, the intangible can help distance your product from the rest of the category. If you currently market using the “Wizard of Oz” approach to product development (create the buzz, myth, mystery and interest first, then obtain the science if needed), it is not too late to reposition yourself and redefine the products through scientific validation. A study today could mean more validation and valuation tomorrow.
Douglas Kalman, PhD, MS, RD, FACN, is director of clinical nutrition at Miami Research Associates (MRA), Miami, FL, in the Nutrition and Endocrinology Division. MRA is a clinical service organization involved for over 10 years in phase II through post market trials for the pharmaceutical and nutraceutical industries. Mr. Kalman is also an active member of the American College of Sports Medicine, American College of Nutrition, the American Dietetic Association, the National Strength and Conditioning Association and the Association of Clinical Research Professionals. He is also the executive vice president and treasurer of the International Society of Sports Nutrition (ISSN). He can be reached at 305-666-2368; Fax: 305-669-8966; E-mail: dkalman@miamiresearch.com; Website: www.miamiresearch.com.
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