Did FDA overstep bounds in warning letter on probiotics claims?

The recent warning letter sent to Great Healthworks Inc. founder Ken Meares​​ cited the company for allegedly impermissible claims on the company’s Probiotic XL product that includes an ingredient branded as ClearPhage, a blend of four bacteriophages, as well as 11 probiotic species.

Among the claims that the FDA issuing office in San Juan, PR, cited as unapproved drug claims were these:

• “Combats bad bacteria”​
• “Targets harmful bacteria”​
• “Reduces yeast growth.”​

Rebalancing the gut part of probiotic claims for years

Claims of rebalancing the gut microbiome have been central to the messaging around probiotic activity for many years.  For example, a 2018 review paper​​ from a team of Italian researchers had this to say:

“Dysbiosis status has been related to various important pathologies, and many therapeutic strategies aimed at restoring the balance of the intestinal ecosystem have been implemented. These strategies include the administration of probiotics, prebiotics, and synbiotics; phage therapy . . . “​

Attorney Ivan Wasserman, managing partner of the firm Amin Talati Wasserman and the chief counsel of the International Probiotics Association, said the nature of the warning letter’s observations points out that FDA issuing offices might see things slightly differently from one another.  And the Agency has at times enforced claims in a way that might overstep the letter of the actual law.

Overstepping the law?

“First, it is important to understand that this warning letter in no way suggests that the probiotics in the product do not have the claimed effects.   The warning letter only reflects the issuing office’s opinion that the identified claims  cause the product to be a drug because they suggest that the product is intended to treat or prevent a disease,”​ he said.

“ With respect to the claim ‘combats bad bacteria,’  ‘Bad bacteria’ are not by themselves diseases.  We  all have ‘bad bacteria’ in our bodies, and maintaining  a healthy microflora balance is essential to maintaining good health.  That is an important role of probiotics and prebiotics,” ​Wasserman added.

“ To me, this is very different from an antibacterial or antibiotic claim.    The  issuing office must believe that ‘combats bad bacteria’ is either akin to a broad antibacterial claim, or that  it ​necessarily implies to consumers that the product will treat or prevent some type of bacterial illness.   It is similar to FDA’s position on cholesterol.  It is not a disease, but FDA’s position is that a claim that product will reduce cholesterol necessarily implies that it will treat or prevent cardiovascular disease,” ​he went on.

“Is FDA correct under the law?   Unless someone challenges the position in court we may never know,” ​Wasserman concluded.