SILVER SPRING, Md., Aug. 16, 2018 /PRNewswire/ -- Over the last
several years, there's been growing scientific and public interest
in the role of microorganisms in the maintenance of overall health
and prevention and treatment of disease. Today, more so than ever
before, consumers are familiar with the phrase "good" or "helpful"
bacteria and the expectation that it will aid in treating or
preventing various illnesses. As the field advances, the U.S. Food
and Drug Administration is playing a key role in sorting through
the science and the science fiction of this evolving field.
We know that certain medical issues, such as bacterial
infections and their treatment with antibiotics, may disrupt the
normal complement of microorganisms that naturally live within the
body. Microbiota, the collection of organisms in and on our body,
may also affect how patients respond to certain drugs, as some
research has shown the possibility of manipulating the microbiota
to improve cancer treatment. There is also some preliminary
evidence suggesting that certain microorganisms or "good bacteria"
given proactively may help prevent some diseases.
For example, researchers are studying whether the administration
of certain microorganisms in the form of probiotics can help
prevent a serious disease in premature infants called necrotizing
enterocolitis, which has been associated with systemic infection
and death. With the health and safety of this most vulnerable
population in mind, more research is needed as to whether this is a
viable treatment.
The data collected so far in premature infants are difficult to
interpret because different probiotic preparations have been
studied, often in conjunction with other interventions.
Understanding whether the use of probiotics for premature infants
can have a clinically significant beneficial effect, and which
types of probiotics may be most effective, is important, as serious
side effects have been reported with their use in this population.
We are very concerned by these potential risks and are actively
monitoring these uses. These risks underscore the need for more
definitive evidence showing benefit in preventing serious diseases.
We need to make sure that the products are delivering benefits that
justify any potential risks. This is especially important as these
products are being used in vulnerable patients. We will consider
taking action when we see unsafe or violative products.
In 2016, the FDA issued a guidance document that explains how
researchers studying probiotics as drugs can meet the manufacturing
requirements necessary for early clinical trials. More work and
continued partnership between the FDA and various stakeholders is
needed to advance the clinical science necessary to appropriately
understand the safety and effectiveness of these products. We are
committed to these goals.
The FDA has also not approved any probiotic as a live
biotherapeutic product (LBP), a biological product other than a
vaccine that contains live organisms used to prevent or treat a
disease or condition in humans. However, there are FDA-regulated
foods, including dietary supplements, containing probiotics that
are legally available, though these products cannot lawfully be
marketed to cure, mitigate, treat, or prevent any diseases. The
2016 guidance also clarifies how some LBPs that are lawfully
marketed as a food or dietary supplement can also be studied for
investigational use.
The FDA is also considering ways to provide additional clarity
on information provided on the supplement facts label for declaring
colony forming units of probiotics and weight. We understand that
there continues to be growing interest in the potential benefits of
probiotics in foods, including dietary supplements, and we are
committed to working with industry on efforts to provide
information that can help consumers make more informed choices
about these products.
Given the strong interest and rapidly evolving science in this
field, the FDA is convening a workshop co-hosted with the National
Institutes of Health on September 17 that will discuss
microbiome-based products and how manipulation of the microbiome
may potentially be used to prevent or treat a variety of different
diseases. Presentations will be given on a variety of topics
including: the regulatory framework for live microbiome-based
products; safety and effectiveness of live microbiome-based
products used to prevent, treat, or cure diseases in humans; and
strain selection for live microbiome-based products to prevent,
treat, or cure diseases in humans. The workshop will also
include panel discussions. We look forward to the robust scientific
conversations that are certain to ensue.
This workshop is part of our broader effort to advance
regulatory science in this field, and make sure we establish
modern, efficient policies for how we evaluate products that fall
under our different regulatory authorities. We recognize the
potential benefit offered by these products, but we also have
identified certain risks. We need to make sure that these are
properly evaluated when these products are marketed and used as
drugs, and that consumers have good information on which to base
decisions when probiotics are used in conventional foods and
dietary supplements. By doing our part in facilitating the conduct
of well-designed clinical trials, the FDA and NIH hope that the
full potential of the new science of the microbiome can be realized
to benefit both individual and public health.
For more information:
Federal Register: Meetings: Science and Regulation of Live
Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases
in Humans; Public Workshop
Science and Regulation of Live Microbiome-Based Products Used to
Prevent, Treat, or Cure Diseases in Humans
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
Media Inquiries: Lyndsay Meyer, 240-402-5345,
lyndsay.meyer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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SOURCE U.S. Food and Drug Administration