Research about Prebiotin

Prebiotin has always been committed to backing its products by third-party medical research:

“Jackson GI Medical is dedicated to the responsible development and marketing of medically credible nutritional supplements in an all-too-often irresponsible marketplace. We back our product with third-party medical research and emphasize no-nonsense, no-hype educational materials on our site. A nutritionally-aware customer is our favorite customer, so please contact us if you have any suggestions.” – Founder, Frank W. Jackson, M.D.

Prebiotin™ is currently involved in several clinical studies using their product. Two are funded by the NIH, and results will be reported on our website when allowed, per NIH release guidelines.

Information about the National Institutes of Health

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

Thanks in large part to NIH-funded medical research, Americans today are living longer and healthier. Life expectancy in the United States has jumped from 47 years in 1900 to 78 years as reported in 2009, and disability in people over age 65 has dropped dramatically in the past 3 decades. In recent years, nationwide rates of new diagnoses and deaths from all cancers combined have fallen significantly.

NIH is the largest public funder of biomedical research in the world, investing more than $30 billion in taxpayer dollars to achieve its mission to enhance health, lengthen life, and reduce illness and disability. In pursuing this mission, NIH improves health by promoting treatment and prevention, contributes to society by driving economic growth and productivity, and expands the biomedical knowledge base by funding cutting-edge research and cultivating the biomedical workforce of today and tomorrow.

NIH is made up of 27 institutes and centers  (often referred to as ICs), 24 of which can make grant awards.

Our ICs award more than 80% of the NIH budget each year to support investigators at more than 2,500 universities, medical schools, and other research organizations around the world. About 10% of the NIH’s budget supports scientists in our own laboratories here at NIH, most of which are on our campus in Bethesda, Maryland.

Each IC has a separate appropriation from Congress, and the director of each IC decides which grants it will fund, taking into consideration input from their staff, the results of the scientific peer review of the grant application, public health need, scientific opportunity, and the need to balance its scientific portfolio. NIH only funds research that has been judged highly meritorious in the peer review process.

How does commercially funded research differ from NIH funded studies?

https://blogs.scientificamerican.com/guest-blog/can-the-source-of-funding-for-medical-research-affect-the-results/

As most researchers know, budget constraints at the NIH have resulted in very low funding rates for grant proposals. In many grant review panels of the NIH, only the top 10% of grant proposals are funded. For a study to qualify for NIH grant funding, it has to go through a very thorough and arduous review process. In some ways, therefore, NIH funding can also be seen as a “badge of excellence”.

Regarding the FDA:

http://www.fda.gov/Food/DietarySupplements/default.htm

The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin, mineral, herb or other botanical, amino acid, or dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.  That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.

Prebiotin founder and visionary, Dr. Frank Jackson, preemptively submitted research to the FDA although it was not required under their guidelines of oversight.  He did this to be proactive in a world of unregulated supplements.

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114092.htm

Structure / Function Claims Proactively Submitted to the FDA