Printed Brochures Are Labeling
Ensure ingredients are GRAS for the marketed population
FDA has been paying close attention to probiotic products marketed to preterm infants recently, and this letter shows the continuing trend.
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An interesting part of this warning letter is that printed brochures are cited. Of course, all marketing is an extension of the label, but in this digital era, this is rare. FDA references claims made in a printed brochure that was given to hospital staff. Other than tradeshows and items gathered during GMP inspections, I can’t remember seeing printed brochures cited in the recent past. The lesson here is that even printed literature can elevate the risk of a warning letter.
From warning letter: Your “Probiotics and Preterm Infants: Clinical Evidence” handout provided by your sales representative to hospital staff has a section with the heading “Probiotics in the NICU: Clinical Evidence” that states, “Probiotics have shown to significantly improve outcomes” for “All-cause mortality,” “Necrotizing enterocolitis (NEC),” “Late-onset sepsis,” and “Feeding tolerance,” and that represents “Benefits of probiotics on NEC,” as “significantly reduc[ing] incidence of NEC in clinical studies.” The other marketing handout with the heading “The Promise of Similac Another Innovation Only From Similac” states that Similac® Probiotic Supplement undergoes safety testing to “ensure the probiotic is ready for hospital use”
FDA took issue with a few of the probiotic ingredients in the product. For example, this probiotic is considered a new dietary ingredient (NDI), and the FDA states there is insufficient safety data to back up its use in preterm infants. According to a well-known supplier’s website, this ingredient is GRAS, but I wonder if the safety data applies to preterm infants. If the product was not marketed to preterm infants, it probably wouldn’t have been mentioned in this letter, in my humble opinion.
From warning letter: “S. thermophilus (TH-4®), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, when used in preterm infants.”
There is a lot more to this warning letter, such as FDA’s comments regarding the safety of B. infantis in preterm infants. Please share your thoughts on this. Here’s the FDA press announcement.
Read the full letter here.
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