FDA Must Find Regulatory Balance for Probiotics Says School of Law Professor
The U.S. Food and Drug Administration (FDA) should consider the unique
features of probiotics--bacteria that help maintain the natural balance
of organisms in the intestines--in regulating their use and marketing,
says Diane Hoffmann, JD, director of the Law and Health
Care Program at the University
of Maryland Francis King Carey School of Law and lead author of the
newly released Science
article, "Probiotics: Finding the Right Regulatory Balance."
The FDA has no definition of probiotics and regulates them based on
whether they fall into one of the existing regulated product
categories, says Hoffmann, who along with faculty members from the University of Maryland School of
Medicine's Institute for Genome Sciences, the School of Pharmacy, and
the UM Carey School of Law, investigated how probiotics are being
The authors brought together a working group of scientists conducting
microbiome and probiotics research, legal academics, food- and drug-law
attorneys, government representatives, bioethicists, and consumer
advocates to examine the current regulatory structure to determine if
it adequately accounts for the risks of probiotics as well as the
accuracy of claims of effectiveness. They also considered whether the
regulatory structure is flexible enough to allow for (or at least not
discourage) research on new probiotic products that may have
The project was supported by a three-year grant from the National
Institutes of Health as part of the Ethical, Legal, and Social
Implications component of the Human Microbiome Project. Claire Fraser, PhD, and Jacques Ravel, PhD, professors at
the School of Medicine and leading experts in the field of human
microbiome science, participated in the study.
"One of the outcomes of the Human Microbiome Project is a tremendous
interest in targeting these microbial communities with probiotics to
both improve health and mitigate disease", says Fraser, whose research
focuses on the role of the gut microbiome in a number of chronic
diseases and its interaction with the immune system. But according to
Ravel, a professor of microbiology and immunology, "there is confusion
about the regulatory process, in particular knowing within which
product category different types of probiotics fall, and the current
regulatory framework discourages the development of probiotic food in
preventing disease, improving health, or possibly treating disease."
In their article, the authors recommend that the FDA consider changing
the way it characterizes probiotics and modifying two regulatory
pathways. "This will help reduce the number of unsubstantiated
probiotic claims and help consumers make more informed decisions as
well as encourage more research on probiotics," says Hoffmann.
Probiotics, which contain live organisms that degrade over time, have
been consumed for centuries in the form of yogurts and fermented milks.
Supermarket shelves are lined with a variety of probiotic foods and
probiotic supplements are being aggressively marketed in retail stores
and over the Internet. Although no probiotic has of yet been approved
for therapeutic purposes by the FDA, some are undergoing clinical
trials and may soon be marketed as biologics or other drugs--a
development that prompted Hoffmann and her colleagues to examine the
potential regulation of probiotics.
Current FDA regulatory requirements are not customized for probiotics.
While probiotics that make drug claims should normally be subjected to
the same requirements as other drugs, under "limited circumstances,"
Hoffmann and her colleagues recommend an "abbreviated" process for some
types of probiotic products. These products include: probiotic foods,
dietary supplements, and dietary ingredients for which there is
adequate evidence of safety in the target population; approved food
additives and substances generally recognized as safe. An "abbreviated"
process would allow probiotics to be excused from Phase l trials, the
first step in clinical testing.
A second recommendation of the working group, says Frank Palumbo, PhD, JD, MS,
professor at the law school and executive director of the School of
Pharmacy Center on Drugs and Public Policy, is that the FDA develop a
monograph for probiotic foods and dietary supplements similar to that
used in Canada or employed by the FDA for over-the-counter drugs.
Because all claims in monographs must be substantiated by
evidence-based science, requiring a monograph to accompany probiotics
should significantly reduce the number of false scientific claims.
Additionally, notes Palumbo, compliance with monograph requirements
lead to expedited review for the application for marketing probiotic
The article's other co-authors are: Karen
Rothenberg, JD, MPA, Marjorie Cook Professor of Law; Virginia Rowthorn, JD, managing
director of the Law and Health Care Program and co-director of the University of Maryland Global
Health Interprofessional Council, and Jack Schwartz, JD, adjunct professor
of law. All are faculty members at the UM Carey School of Law.
|Posting Date: 10/18/2013
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