Do we really need new studies for our products?
With the recent emphasis on clinical research in product formulation, a trend of borrowing research has emerged. Borrowing research refers to the use of existing research to identify the capabilities of an ingredient in natural products. The scientific literature offers a wealth of knowledge about the potential effects your main ingredients may offer your finished products. Many formulators rely on the existing published research to substantiate claims about the product's effects.
This shortcut is an appealing one, but is insufficient for the task at hand. Existing studies can only identify potential because they differ from studies conducted on your finished product. The gold standard for substantiation comes from human studies conducted on your unique product. While existing studies are useful for identifying potential, they are insufficient to confirm actions within finished products. Borrowing research to substantiate your product's claims is a risky business.
Borrowed studies that fail most FTC investigations:
- Studies conducted on animals
- Alternate routes of administration
- Variances in dosing or delivery method (i.e. capsule vs syrup)
- Alternate extraction processes
- Differences in total concentration of active ingredient in finished product
- Variations in raw material composition (often due to seasonal variability or different growing conditions)
- Differences in sample demographics and your product's market (race, sex, age, region, etc)
- Manufacturing differences
- Differences in formulation (i.e. using a study on a single ingredient to substantiate a combination product or vice versa)
Clinical Trials: Worth the Investment
When it comes to scientific substantiation, the gold standard is a clinical trial conducted on your finished product. Clinical research is sometimes seen as a necessary evil and a financial risk, but these same studies are able to deliver substantial marketing potential. Clinical trials also protect your company from liability and provide a cutting edge in this rapidly growing industry. The more research a company conducts, the better their success in the marketplace.
Meet Dr Hawkins
Dr. Hawkins brings 20 years of expertise in the integrative health field to her role as Executive Director of the Franklin School of Integrative Health Sciences and the leader of our clinical research team.
She holds a Bachelor’s Degree in Environmental Health from Union Institute and University, a Master’s Degree in Health Education & Promotion from the University of Alabama, a post-graduate certificate in epidemiology from the London School of Hygiene and Tropical Medicine, a PhD in Health Research from Middle Tennessee State University, and is completing the post-doctoral Global Scholars Research Training Program at Harvard Medical School. She also holds certifications in numerous natural health fields including aromatherapy, aromatic medicine, herbalism, childbirth education, and labor support.