The Research Process: Regulatory Impacts on Science

By Douglas Kalman, PhD, MS, RD, CCRC, FACN | March 1, 2012

Proper finished product testing can help avoid FDA or FTC action.

As 2012 shifts into gear, some interesting things are happening on the regulatory front. To me, as a scientist who works in early stage medicine and nutritional products research, regulatory matters affect how research is carried out.

For example, if you are developing a medicine for certain organ diseases, then you must also test that medicine in early phase trials on subjects with renal (kidney) disruptions. This hasn’t always been the case. In fact, FDA recently started “encouraging” pharmaceutical companies to test medicines that are already in late stage development, or currently on the market, for tolerance among people with liver or kidney disease. This kind of research has typically been done in early stage trials, so this represents a side step, or a step backward in the approval timeline and practice.

In the natural products realm, many companies are “forced” into doing research as a result of litigation, Attorney General interest, a Better Business Bureau-National Advertising Review Council (NARC), Electronic Retailing Self-Regulatory Program (ERSP) or National Advertising Division (NAD) review, or even Federal Trade Commission (FTC) action. Thus, at times, clinical research studies are needed after going to market. Still, it is best practice to have your finished product studies done beforehand in order to substantiate marketing.

When FTC evaluates a product in the marketplace it analyzes truth in advertising. The agency often refers to its measurement standards as the “Pfizer factors.” In 1972, FTC essentially set six factors that are still used today in review and consideration of substantiation.

The six factors are: 1) the type of product; 2) the type of claim; 3) the benefits of a truthful claim; 4) the cost/feasibility of developing substantiation; 5) the consequences of a false claim; and 6) the amount of substantiation that experts in the field believe is reasonable.

For claims related to health or safety, the commission has determined that these factors translate to “competent and reliable scientific evidence,” which has been defined in numerous consent orders as: “tests, analyses, research, studies or other evidence based upon the expertise of professionals in the relevant area that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

FTC has indicated companies can take several steps that will put them in good position in the event of a query. The current working definition of competent and reliable science is: at least two adequate and well-controlled human clinical studies of the product at issue or substantially similar product, conducted by different experts independently of each other that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate the health claim (product claim).

The Natural Products Foundation (NPF) has initiated a “Truth in Advertising” campaign designed to self-police the industry. The board members of the NPF, through its legal advisor and chair, are pro-actively communicating with FTC and FDA regarding advertisements and companies that are found to be in violation of the law.

The typical violation is a drug and disease claim. Out of 85 companies contacted by the NPF group (and asked to fix their advertising), a whopping 41% ignored the free legal advice and were referred to FDA and FTC for direct legal action. In these cases, it seems the NPF has done the homework for the government and this form of self-regulation, much like working with the ESRP/NAD and NARC programs of the BBB, can only help to shape a quality-focused industry.

In my mind, a recent press release regarding a study of Xanthigen, from P.L. Thomas, demonstrates the need for U.S.-based finished product studies. Dr. Vladimir Badmaev stated: “results indicate that Xanthigen may suppress fatty tissue build up through multiple mechanisms and may have further explained applications for this dietary supplement in improving liver functions and managing obesity.” The statement relates to an in vitro study published in the Journal of Agricultural and Food Chemistry.

A mechanistic study (one that looks to elucidate a mechanism of action for a drug or product in a biological system), does not always translate to how the product will actually work in a real human being. Thus, Dr. Badmaev’s statement is more of an implied nature and not necessarily true of any finished product that contains the tested pomegranate oil/seaweed-based ingredient.

There was one published human study, but it was conducted outside the U.S., and FDA and FTC have indicated a preference for finished product studies done in the U.S. (or related areas) over those done in other parts of the world. Thus, there seems to be an opportunity here for a product, which perhaps demonstrates potential for overweight or obese Americans, to ensure it doesn’t end up on the “watch list” of regulatory authorities.