Can a company design a study for a condition-specific product and still be in compliance with the Dietary Supplement Health & Education Act (DSHEA) and subsequent laws? By law, as most people know, dietary supplements cannot be marketed to treat, prevent or cure any disease, which is why FDA requires that the following statement be listed on all dietary supplement products: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
 
Claims
 
The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim or a structure/function claim. Health claims describe a relationship between a food, food component or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body—but it cannot mention any specific disease. Remember that to be fully DSHEA-compliant one must also submit to the FDA any structure/function claims that are going to be made within 30 days of going to market (it does not need approval; it just needs to be submitted). While one does not need FDA approval on a structure/function claim, one does need substantiation for any claim that is being made.
 
Most important, the marketing related to a supplement cannot state that it prevents or reduces the risk of a disease or health-related condition unless the claim has been approved by FDA.
 
Conditions As Diseases
 
If you accept the notion that conditions are related to diseases, then let’s consider that Metabolic Syndrome (“MetSyn”)—a combination of abdominal obesity, elevated blood pressure, high triglycerides, low HDL (the “good” cholesterol) and/or high blood sugar—might also be a disease. While this condition (MetSyn) is not formally recognized by FDA as a disease, many health organizations have definitions for it.
 
Recently, two studies published in peer-reviewed journals detailed the effects of a dietary supplement on bone metabolism in postmenopausal women with MetSyn. The dietary supplement contained 200 mg hop rho iso-alpha acids, 100 mg berberine sulfate trihydrate, 500 IU vitamin D(3) and 500 mcg vitamin K(1), and was taken twice daily for 14 weeks. The purpose of these studies was to evaluate the impact of a dietary supplement (“targeted phytochemicals and nutrients”) on bone turnover markers in healthy postmenopausal women and postmenopausal women with MetSyn.
 
These studies found this specific dietary supplement produced a more favorable bone biomarker profile indicative of healthy bone metabolism (i.e., positive changes in osteocalcin, 25-hydroxyvitamin D and with type-I collagen) in healthy postmenopausal women as well as those with MetSyn.
 
Here’s the tricky part. FDA has indicated that in order to conduct a human interventional clinical trial with a dietary supplement on a “diseased” population, an Investigational New Drug (IND) application must be filed. INDs require a lot of paperwork, are laborious, and might affect opportunities to market the product as a dietary supplement. In other words, FDA says any product being studied for anything that is not quality-of-life related and where the primary endpoint is disease related (e.g., change in lipids in a group of people with elevated cholesterol outside the normal range) you need an IND. This is all well and good unless you want to take that study product to market as a supplement. A perfect case in point is the recent New Dietary Ingredient (NDI) rejection of homotaurine.
 
FDA rejected homotaurine as a dietary ingredient because it once was submitted as part of an IND package for potential development as a drug. Going forward, it will be an uphill battle for the company to argue that this ingredient be considered a supplement and not a drug. In fact, it appears from the February 2011 FDA ruling on homotaurine that once an ingredient gets the FDA stamp of approval for research under the IND program, then the agency has the power to remove the product or ingredient from the supplement marketplace.
 
The studies mentioned previously by Drs. Holick and Lamb provide some evidence that their unique intervention aids in healthy bone metabolism and has potential in those who are at increased osteoporotic risk. But there are still some unanswered questions: 1. Did the researchers or sponsor know they needed an IND application for their 2011 study (since it was in women with MetSyn)? 2. If they did file an IND application, can the studies be used as part of product substantiation, since the group studied had a “condition”? These are important issues to consider in designing clinical trials. While research is certainly important, one must be cognizant of the subtle details that might affect the product’s target population and marketability in the future.
 
References furnished upon request.