The Food
and Drug Administration decided late last week that it would not seek to
regulate fitness trackers and wellness mobile apps, freeing the industry from
rules that could potentially slow progress in the field.
The FDA
released its stance through a guidance document titled, “General Wellness:
Policy for Low Risk Devices Guidance for Industry and Food and Drug
Administration Staff,” which also makes it clear that all recommendations are
nonbinding. Instead, the guidance “describe[s] the Agency’s current thinking on
a topic and should be viewed only as recommendations, unless specific
regulatory or statutory requirements are cited.”
The
recommendation covers products intended only for general wellness, according to
Bloomberg BNA, including tools for weight management, physical fitness or
mental acuity. The FDA document also states that the guidance does not apply to
products that refer to specific diseases or conditions, or products that say
they can be used to treat or diagnose a disease or disorder.
Making
the distinction between healthcare and wellness products is important for the
FDA and for industry participants, Bloomberg BNA said. This is because
developers “want to be able to market their products as helpful to people with
certain medical conditions but want to steer clear of FDA regulations, which
can be time-consuming and expensive.
“Products
regulated by the FDA must register with the agency, undergo review before
they’re sold, and meet certain requirements,” according to Bloomberg BNA.
It’s clear
that the FDA is referring to very low-level fitness trackers and apps in its
document, ones that consumers wouldn’t mistake for “fix all” health solutions.
Using
illustrative examples, the FDA document describes six products that would fall
under the “don’t regulate” recommendation, including fitness bands, meditation
apps, diet tracking apps, skin exfoliation products, and more.
Sen.
Lamar Alexander (R-Tenn), chairman of the Senate Health, Education, Labor, and
Pensions Committee, told Bloomberg BNA that he was happy to see the FDA’s
recommendation and that it “has no current plans to put unnecessary government
red tape between people hoping to use a FitBit to help them get moving or a
Weight Watchers application to monitor their diet.”
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