Is it surprising when a large corporation enters the dietary supplement/natural products sector and doesn’t become a leader? By leader I mean lead the industry in quality, science, product experience, adherence to regulatory guidance and more. Perhaps I have been sadly mistaken in believing that the multi-billion dollar organizations that enter this space, which also have a foot in the pharmaceutical sector, would transfer their quality control to this sector.

One surefire way to build a sustainable business is to create a product that has been clinically validated to perform as advertised, and offers the end-user a reproducible experience. But it hurts the nutritional products industry when “Big Pharma” enters this space while not adding anything to it.

Transparent and consistent science, along with the right distribution and retail outlets, should translate into a sustainable business model. On the other hand, there are companies and products that are marketed through hype with smoke and mirrors (borrowed science plus a slick website and manipulative wording). The products themselves might be quite good; however, the quality and type of presentation made to the public and regulatory agencies is questionable, for short-term gain and hurts the industry overall.

Sadly, many products are advertised or marketed in a way that befuddles consumers trying to understand the science behind the product or how the product is different from others in the same category.

Latest Offender?

FDA’s recent guidance document regarding what constitutes a beverage (traditional) versus a liquid supplement asks the question: If the product is designed to look like a beverage and in fact is sold in the typical drinkable format (i.e., plastic, pourable bottle), then why shouldn’t it be considered a traditional beverage?
 
Furthermore, FDA’s guidance mentions ingredients that are typically added to dietary supplements sold as beverages, or what appear to be beverages. FDA indicates that many of these ingredients do not have food additive or Generally Recognized as Safe (GRAS) status. It will be interesting to see how this pans out—considering all of the  “shot” products and those that appear to be a beverage/supplement.
 
One product that may exemplify FDA’s concern is Elations, which is marketed as a liquid joint health product that delivers glucosamine and chondroitin. The product does in fact utilize the Supplement Facts label (ingredients also include calcium and boron). The primary Elations product comes in liquid form and is typically found in the supplement or health section of the supermarket. According to the product’s website, Elations claims to help improve joint comfort in people with osteoarthritis within six days. Isn’t osteoarthritis an FDA-classified disease, which makes this claim (borrowed from non-referenced, non-transparent studies) run afoul of DSHEA and subsequent laws?

Elations as a company was born out of the pharmaceutical and consumer packaged goods behemoth Proctor & Gamble (P&G), whose sales in 2009 (fiscal year) topped $70 billion. Since one cannot easily read the actual studies that are not even truly cited as substantiation for this product’s claims, one has to wonder if the old “Wizard of Oz” trick is being played here. Moreover, when one views the management board for this company, there is not one scientist listed—not one. This fact is disturbing.

Nonetheless, I contacted a manager of the Elations brand. In fact, after the Elations company sent out a mass e-mail to health professionals as a follow up from the ACSM meeting earlier this year, I replied with one simple question: “Can I have a copy of the peer-reviewed, published studies on Elations?”

The answer I received, my friends, inspired this column. In short, the product/brand manager informed me that all of the science that I ever needed to know on the Elations drinkable product was available on their website. Thus, the lack of transparency of science, coupled with the lack of any published, peer-reviewed, finished-product studies makes me believe that this is just another company who has gotten into the supplement business for the money (potential profits), while not really seeking a long-term position or to help bolster the market.

What is in fact so disappointing is that the parent company certainly knows what finished product, clinical research is, and understands the importance of direct evidence of product utility. Do you think P&G would have ever released their probiotic Align, or any of their pharmaceuticals, without having all of their ducks in a row? (Remember, the Center for Drug Evaluation and Research (CDER)—as discussed in a previous column—is contemplating reclassifying probiotics as biological agents, which would induce new regulations for the category.)

P&G as a corporation has the resources to support R&D to a greater degree than many other companies. However, the bold statement on the Elations homepage, coupled with the admitted lack of any peer-reviewed, published, product studies begs the question: What is missing from this picture?

Where to Go From Here

With long-term growth of the industry in mind, and to establish a sustainable business model, companies should always aim to have finished product studies prior to going to market. Even if all of the ingredients in the product are already FDA-approved or grandfathered in and, most importantly, have published clinical data to support their individual use, a finished product study is still a good idea.
 
Simply combining ingredients does not always add synergy or improve effectiveness. Having your own finished-product study also adds to the product and company valuation. While I cannot speak directly to the Elations product and the large marketing push, which is not supported by robust science, it is my hope that this column ruffles a few feathers. After all, we as consumers also appreciate good products that are transparent in why and how they work. Now, what the industry response will be as related to the liquid beverage versus supplement guidance will be interesting to follow.