Consider the marketing and regulatory advantages of testing your products, particularly as a PROGRAM to provide credibility and protect your brand. Here are some examples of studies I designed to test for efficacy:

1. Effect of 30-day [Isagenix weight loss] program vs. TLC diet to reduce risk factors of metabolic syndrome and inflammation in older women  

2. Evaluation of the effectiveness & safety of Absorbitol Plus ™ in patients with borderline hypercholesterolemia: A Randomized, Crossover, Placebo-Controlled Trial

3. Impact of Chitosan supplementation on body weight and plasma cholesterol

4. Glycemic effect of meal replacement bars

5. Clinical efficacy of two joint formulations to reduce swelling, pain and inflammation in healthy older adults with osteoarthritis

6. Bioavailability of alfalfa mineral mix in rats

7. Effect of CLA and AA supplementation on body composition and muscular strength in older women

8. The effect of drinking alkaline water on urine pH

9. Dietary CLA alters body composition and lowers cholesterol and TG in healhty men.

10. A novel nicotinic acid based dietary supplement reduced TG in healthy, hyperlipidemic adults. 

     

     

Investing in Good Science 

The development and introduction of nutraceutical products has grown rapidly, making it a leading topic of interest, as well as a source of misunderstanding and disappointment to consumers.  

The key to the industry’s success and to regain confidence will mean having credible scientific evidence to substantiate the health benefits on those products that  marketers advocate.

Establishing consumer confidence entails supplement companies to consistently deliver products with the highest quality in manufacturing and provide scientific validity on any marketing claims.

How you do this with cost always a critical factor is to know the business of science and the business of selling products!  You must work smart.

Clinical studies are really the only way to add credibility to claims and provide evidence to FDA/FTC that your product is valid!  You must substantiate claims with clinical evidence or "Proof of Concept. Eventually, this will be the norm.

Additionally, below are some of the key  factors to consider prior to marketing a new dietary ingredient for the use in dietary supplements.

1. Regulatory basis of the chosen ingredient(s) (food or supplement--health claim or structure/function claim; food label or nutrition facts label)
2. Safety data for the chosen ingredient(s)
3. Identification and quantification of the bioactive(s)
4. Understanding the biochemistry, metabolism and efficacy of the chosen ingredient(s)
5. Understanding the effect of environmental conditions on bioactive(s) of the chosen ingredient(s)
6. Estimating shelf life of the chosen ingredient(s)
7. Checking the legal status of that ingredient in your formula (is it protected by another patent?)
8. etc., etc., etc.      

As the supplement industry matures, more companies will need to invest heavily in research and development, particularly in human clinical study. Hiring an experienced, knowledgable scientist is crtical and necessary--the value added benefit can be the difference of success or failure for a company. 

Unfortunately, according to the Consumer Healthcare Products Association (CHPA), there is a lack of incentive for individual firms to invest in creating solid scientific dissemination.  Part of the problem is that the quality manufacturer that does invest in scientific research does not typically gain exclusive right for a specific ingredient. For example: If a company invests on clinical research for a specific health benefit of botanical “Y”, the company does not get exclusivity for botanical “Y”. Hence other companies can (and do) use the clinical information to market the botanical without the capital investment in research and development.

Ultimately, consumer choice for quality products and increasing regulatory and enforcement pressure for performance claim substantiation and truth in labeling  will force companies to carry out solid research on individual products rather than using “borrowed science” to product “me too” imitation products whose end result is an erosion of consumer confidence in dietary  supplements. 

Therefore, it is of paramount importance for those dietary supplement companies to substantiate their product’s efficacy and quality with scientific research to ensure the continued growth of the industry.

 Reference:

1. Lachance P. Nutraceuticals, for Real. F. Technology. 2002; 56(1):20
2. DeFelice S. Foundation for Innovation in Medicine. (http://www.fimdefelice.org)
3. Schmidl M, and Labuza T. Essentials of Functional Foods. 2000:15-44
4.  Dietary Supplement Health and education Act of 1994. U.S. Public Law No.103-417.
5. Kitzmiller G. Are Supplements Sick? Nutraceuticals World. 2002;5(3):22-23