Test tubes for clinical trialsYou have a strong brand, a great product concept and have identified your ultimate target market.  You’re eager to get out there and sell, but regulatory authorities are saying you need stronger evidence in order to substantiate your product’s claims. Now what?

If you’re in the natural health or functional food industry, you might be all too familiar with this scenario.

It seems as though company after company is taking a regulatory slap on the wrist for unsubstantiated claims, misleading advertising statements or overly aggressive marketing.  The latest example is POM Wonderful pomegranate juice, whose drug-like claims regarding prostate cancer were scrutinized by the Federal Trade Commission (FTC).

Similar cases have been seen in the dietary supplement/natural health product industry.  Recently, Pfizer agreed to drop “breast health” and “colon health” claims from the labels of its widely used Centrum multivitamin supplements following complaints from the consumer group Center for Science in the Public Interest (CSPI) (view article here).

The key to avoiding the same fate?  Ensure that what you are saying about your product is backed by solid scientific evidence that is defendable and reproducible

In Canada, natural health product (NHP) health claims are reviewed and evaluated by the Natural Health Products Directorate (NHPD) of Health Canada.  The NHPD recognizes data generated from many different types of research, but gives the most weight to evidence that has been generated from well-designed randomized clinical trials (RCTs).  For more details, click here.


Levels of Evidence
Type of Evidence from Human Studies
Well-designed systematic reviews and meta-analyses of randomized controlled trials or other clinical trials, or at least one well-designed randomized controlled trial (preferably multicentred)
Well-designed clinical trials without randomization and/or control groups
Well-designed descriptive and observational studies, such as correlational studies, cohort studies and case-control studies
Peer-reviewed published articles, conclusions of other reputable regulatory agencies or previous marketing experience, expert opinion reports, referenced textbooks, Web site (if the information is peer-reviewed and there is a hardcover version of the site, e.g. Natural Medicines Comprehensive Database)
References to a traditional use, pharmacopoeias

Not only does the NHPD evaluate the data generated from research studies, they also review (and approves) all proposed clinical research studies with NHPs that are being conducted in Canada.  The scope of the NHP regulations with regards to clinical trials is to ensure:

  • The safety, efficacy and quality of both the clinical trial protocol and the investigational product(s) and placebo/comparator given during the study
  • The safety of clinical trial subjects and other people
  • Compliance with ICH, Good Clinical Practice (GCP) and federal and provincial laws
  • That people with suitable expertise conduct properly designed CTs

Sources: Health Canada; NHPD; Nutra-Ingredients USA; Reuters