Bales Photonics

General Wellness Products

A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

If the product’s intended uses are not limited to the above general wellness intended uses, this guidance does not apply.

The first category of general wellness intended uses involve claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions. For the purposes of this guidance, this first category of general wellness claims relate to:

  • weight management,
  • physical fitness, including products intended for recreational use,
  • relaxation or stress management,
  • mental acuity,
  • self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem),
  • sleep management, or
  • sexual function.

The following are examples of this category of general wellness claims:

  • Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals;
  • Claims to promote relaxation or manage stress;
  • Claims to increase, improve, or enhance the flow of qi “energy”;
  • Claims to improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, logic, pattern recognition, or eye-hand coordination;

“Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the FD&C Act).