under specified conditions (frequency and quantity), and (3) “ecological” balance and support claims that communicate information about how consumption of a given prebiotic or probiotic affects the microbiome.

Ultimately, Roller expressed hope that the health benefits that are being linked to prebiotics and probiotics with respect to supporting and maintaining a healthy microbiome will help inspire the kinds of policy reforms that are needed to allow food and dietary supplement manufacturers to convey accurate and substantiated information about the benefits of prebiotics and probiotics and the products that contain them, consistent with sound science and First Amendment standards. In Roller’s opinion, the current legal framework—the existing “food versus drug” construct that is codified in the FD&C Act—is based on outdated science and is too rigid to allow FDA to account for current science or future advances in science. According to Roller, the current legal framework draws an artificial line between the permissible food benefits of “disease risk reduction” or “health promotion” and the benefits of “disease prevention, mitigation, and treatment,” which are categorically reserved for FDA-approved “drugs,” even when the distinction may not align with scientific facts. In Roller’s opinion, the current situation with probiotics is probably a key moment of opportunity that can allow this long-standing problem to be addressed. Failing to do so could have huge opportunity costs for public health, she added.

Roller speculated on whether it might be possible to adopt an ecological approach to regulating health claims for food products intended to have a beneficial impact on the microbiome, in the same way that environmental law has adopted an ecological approach. For example, fisheries law is based not on individual fish or fish populations, but rather on the environmental conditions required for fish to thrive. She asked, “Does it work for us to think about the microbiome that way?”

REFERENCES

Amar, J., C. Chabo, A. Waget, P. Klopp, C. Vachoux, L. G. Bermudez-Humaran, N. Smirnova, M. Berge, T. Sulpice, S. Lahtinen, A. Ouwehand, P. Langella, N. Rautonen, P. J. Sansonetti, and R. Burcelin. 2011. Intestinal mucosal adherence and translocation of commensal bacteria at the early onset of type 2 diabetes: Molecular mechanisms and probiotic treatment. EMBO Molecular Medicine 3(9):559-572.

Bagramian, R. A., F. Garcia-Godoy, and A. R. Volpe. 2009. The global increase in dental caries. A pending public health crisis. American Journal of Dentistry 22(1):3-8.

Deshpande, A., and A. R. Jadad. 2008. The impact of polyol-containing chewing gums on dental caries: A systematic review of original randomized controlled trials and observational studies. Journal of the American Dental Association 139(12):1602-1614.

EFSA (European Food Safety Authority). 2008. LGG MAX and gastro-intestinal discomfort—scientific substantiation of a health claim related to LGG MAX and reduction of gastrointestinal discomfort pursuant to Article 13(5) of Regulation (EC) No. 1924/2006[1]. European Food Safety Authority Journal 853:1-15. http://www.efsa.europa.eu/de/scdocs/doc/853.pdf.



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