FDA expressed concerns regarding a 75-day premarket notification for a probiotic containing Lactobacillus reuteri due to inadequate information on the bacteria's safety in infants and young children. The notification was submitted June 30 by McNeil Consumer Healthcare.

In a Sept. 18 letter to McNeil, FDA lists shortcomings in the abstract reports and clinical studies the firm provided in its submission, stating they "lack physiological and biochemical analyses." The agency also notes "the duration of treatment with Lactobacillus reuteri is unclear."

Commenting on two studies of the gastrointestinal effects of the probiotic in healthy children ages 12 to 36 months, FDA claims "one of these abstracts lacks information on the amount of Lactobacillus reuteri consumed by the children during the study."

Both abstracts additionally lacked detailed information on clinical measurements that would help evaluate chronic use of the substance, FDA continues.

McNeil responded Oct. 2, citing a Sept. 28 meeting with FDA in which McNeil agreed to modify labeling for its future Lactobacillus reuteri product, Probiotica. The chewable tablet "is not intended for use by infants and children under two years of age, and the notification submitted was not intended to support such use," the firm says.

Concerns about the safety of probiotics, especially in special populations such as infants and geriatrics, were raised at a recent Food Advisory Committee meeting. Safety issues such as purity, product identity, side effects and potential drug interactions were discussed by attendees.

Members expressed particular concern with respect to infants. "You can't just assume because it is safe for general use and has been used for centuries that it is, indeed, safe for specific populations," Madeleine Sigman-Grant, PhD, University of Nevada Cooperative Extension, pointed out.

"Infant formula for the first six months is the sole source of nutrition," Sigman-Grant continued. Due to the critical nature of this period of growth and development, the committee agreed infant formula safety must be well established.

Center for Food Safety & Applied Nutrition Lead Nutritional Scientist Elizabeth Yetley, PhD, noted FDA recognizes this need, set forth in the provisions of the Infant Formula Act of 1997.

The rule requires, in part, that companies "analyze each batch of formula to check nutrient levels and make safety checks. They must then test samples to make sure the product remains in good condition while it is on the market shelf," Yetley said.

When asked how adding probiotics would affect the established regs, Yetley replied that although FDA has proposed GMPs for infant formula with "an indication of a maximum level of organisms, microorganisms, in the formula," the question of "how would that apply if probiotics were to be added...is not an issue we have resolved."

She noted, however, an infant formula containing probiotics would require food additive or GRAS status for its intended use and would have to follow the 90-day notification of intent to market a new infant formula.

Committee members agreed companies also should have to conduct "very definitive double-blind clinical trials" to demonstrate the safety of products containing probiotics that are intended for use by infants.

Additional ways to evaluate the safety of probiotics mentioned at the meeting included testing for toxicity in animals, monitoring for adverse events and conducting safety tests at levels for which there is no efficacy.

The committee stressed the need for public education on probiotics since they represent a relatively new category in the dietary supplement market.

"For the consumer, there really has to be an articulation from FDA...to dispel some of the myths surrounding these things," Donna Richardson, Howard University, stated.

"You are talking about probiotics and bacteria...there is going to need to be some public education about what the benefits are, what the risks are...and the consumer has to realize that, yes, we have been eating yogurt for years, so this isn't something new."

Probiotic Infant Use Raises FDA, Food Advisory Committee Concern

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