Probiotics are living human, animal or environmental microorganisms that can give a health benefit to the host when adequate dosages are administered. In order to be considered a microbe it must be alive when administered and it must have undergone a controlled evaluation to document the health benefits for the target host.
There are a few subcategories of probiotic. Probiotic drugs are meant to cure, treat or prevent disease, probiotic foods are foods, food ingredients and dietary supplements, direct-fed microbials are designed for animal use and designer probiotics which are genetically modified.
There are many common myths regarding probiotics and their use among both consumers and manufacturers alike. Probiotics aren’t completely understood in regard to their benefits, dosage and the constituents.
Many probiotics are from specific microbes like the Lactobacillus or Bifidobacterium genera and the Saccharomyces boulardii (yeast). Escherichia coli or Bacillus coagulans are also strains that are less commonly used as probiotics.
There is a distinction between a virus and a probiotic. Virus’ are not considered to be probiotics. While live virus’ can be administered as vaccines they are still outside the classification.
Also, probiotics are distinct from live active cultures. There are many foods like fermented dairy products or fermented foods that have live active cultures that are not considered to be probiotics because they aren’t meant to provide health benefits.
To reach the maximum benefit the dosage of probiotics should be 1-10 billion CFU (colony-forming units)/day, although dosages can vary being greater or less than that amount.
There are a few challenges facing the probiotic industry. The first is the validation of the health benefit claims of probiotics. Currently, no probiotics have been approved for their health benefit claims, though approval is being sought from both domestic and international regulatory bodies.
Another challenge is human research. It is necessary to find out the bioequivalency of probiotics in multiple circumstances therefore human tests are necessary. Also, human testing will allow regulators, consumers and physicians to have more clarity regarding the effects of probiotics.
Currently no probiotic product is licensed in the United States or Europe as a biological drug product for use in treatment, prevention, cure, mitigation or diagnosis of a specific human disease, however, oral probiotics can be marketed as dietary supplements, conventional foods, medical foods and drugs (biologics).
In order to go forward with probiotics, which have a similar regulation process to live vaccines to prevent infectious diseases, there must first by an Investigational New Drug (IND) application prior to studies on humans can begin.
About the Author
Blair Thomas is the co-founder of eMerchantBroker.com the best high risk merchant account processing company in the country. eMerchantBroker have the best Nutraceutical Merchant Account rates in the industry! When Blair is not running his business, he spends his time writing and producing music, which has been featured in a variety of films.