It all started by the publication of the Federal Drug Administration of a draft of New Dietary Ingredients (NDI) containing a section on probiotics, the gut friendly bacteria that are all the rage in current nutrition science.

We have discussed probiotics and their pros and cons in several previous posts. What transpires from our previous posts is that there is healing potential in probiotics, particularly about immune system. This is not too surprising, because after all, we are talking about bacteria in our bodies. The healing would pertain to:

  • Inflammatory Bowel Disease
  • Crohn’s
  • Ulcerative Colitis
  • Immune system boost

But before we introduce live beasts in our guts, it is common sense to certify that they are safe, at the very least, never mind their efficacy.


BifidobacteriumAnimalis, one of the many guests to your digestive system


So the FDA has taken a very defensive stance about probiotics, but I am not sure we should, as the food industry is doing, blame them.

What the did NDI document say [1] ?

“…You should include a complete description of the organism, including:

  • the strain,
  • methods used to establish the identity of the strain, such as identification by internationally recognized third-party repositories (e.g., the American Type Culture Collection), and
  • the relationship of the strain to the strain(s) of the same species used to establish the history of use or other evidence of safety for the dietary ingredient.
  • FDA considers each strain of a bacterial or yeast species to be a separate ingredient….
  • The notification should explain the relevance of safety information presented about other strains from the same species.

So what has the food industry livid? The FDA requirements are attached to the strain of bacterium , not its genus or species, so they are much more specific.

The industry claims the US Government should stick to require only data at the genus/species level.

Take the well known pathogen E. Coli: From its Wikipedia entry, “… While many Escherichia are harmless commensals, particular strains of some species are human pathogens…”

You can have good and bad strains of the same genus


E. Coli : Some strains benign, others harmful (Wikipedia, US Dept. Agri.)

So the industry’s position is that bacteria with strains having a history of safety should not be considered “new”.  The question is obviously does a past history of safe strains guarantee that no other unsafe strains exist?

As Joe Public, I need to be convinced….



[1] Federal Drug Administration’s Draft on what constitutes a New Dietary Ingredient ; “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

[2] MediNewsDigest:  Study Claims Immune System Boost from Specific Probiotic Bacterium Strain; November 22, 2011

[3] MediNewsDigest: Are Probiotics Gut Bacteria Good or Bad For Multiple Sclerosis Or Other Autoimmune Diseases? ; October 30, 2011

[4] MediNewsDigest: Understanding The Bacteria World In Our Bodies Is Critical To Our Health ; April 25, 2011

[5] MediNewsDigest:  Nutrition and Probiotics: Bacillus Coagulans could be baked, boiled and even frozen. ; January 30, 2011

[6] MediNewsDigest: Probiotics could be helpful against gingivitis (NutraIngredients) ; October 5,2010

[7] Nutraingredients ; ” Probiotic NDIs: Leading groups argue for genus/species vs strain” ; Stephen Daniells, june 2011




1 Comment for this entry

  • C.Fegan says:

    Probiotics seem to be one of the latest must haves in the end user med market. I do believe in their use post antibiotic use. I see so many blends out there with little or no research available. I have used a product called Florastor, that actually did make my gut function well after a hospital stay. I was given it in hospital, and found it OTC afterward.
    I take it 3-4 times a year. it IS costly for a handicapped consumer, $30 US per bottle of 30? However, it makes the strain of slow MS motility less of an issue.

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