Probiota Americas panel to delve into NDI guidance, labeling, additional issues

The regulatory panel will consist of Dr Corey Hilmas, MD, PhD, chief science officer of KGK Science, Solange Henoud, vice president regulatory & compliance at Lallemand Health Solutions Inc., Serna Viswanathan, JD, of the Federal Trade Commission, and Betsy Jean Yakes, PhD, of the Food and Drug Administration. 

The panel will kick off with short presentations from Viswanathan and Yakes.  In the discussion part of the session, several hot topics that are of key interest to probiotics stakeholders will be addressed.

How ought the ingredients be labeled?

One issue that hovers over the industry is how probiotic products ought to be labeled.  The letter of the law would have the amounts of the ingredient quoted in milligrams.  Manufacturers counter that that might miss the point.  The total weight of the ingredient would include fillers and carriers.  What’s important is the CFU count, but that’s not addressed in the labeling regulations as they stand.  What should companies take away from that impasse?

Ongoing  NDI issues

Another burning issue concerns the process of fling a New Dietary Ingredient notification.  There is an unease within the industry about how much confidential information must be divulged in that process.  It’s a concern for the developers of all sort of ingredients.

 In the probiotics sphere this specifically relates to exactly how the probiotic organisms are cultured and then prepared for encapsulation.  FDA employees may state that this kind of information is needed to assess the safety of the ingredient.  Probiotics manufacturers might retort that that’s information won with blood, sweat and tears as part of the development process, and giving it away free to a competitor as might happen in an NDI filing where it all goes onto the public record would be ruinous.

New indications for probiotics

An addition question that the panel will delve into is the expanding indications for probiotics.  Just this week a probiotic that has been on the market with a claim of specific benefit for gout sufferers has announced the start of the development of a drug along those lines.  And another probiotic recently debuted with a claim to positively affect the microbial communities within the lung mucosa.  Probiotics that address the vaginal microbiome have been on the market for years. 

As there are microbial communities in many parts fo the body  (eyes, ears, skin, nose, and, um . . . toes?) that remain under addressed by probiotic formulations, are more of those in the offing? And, if so, how would regulators view that development?

Submit additional questions

If you have other questions you’d like to see addressed as part of the panel email them to unax.fpuhygm@jeoz.pbz​ and we’ll try to fit them into the agenda.