Currently, the Food & Drug Administration (FDA) is in the process of developing draft guidance to provide clarity on compliance policy for low-risk products that promote a healthy lifestyle or general wellness products. By clarifying policy on general wellness products, the agency hopes to improve the predictability, consistency, and transparency on the regulation of these products.

What Is Considered a General Wellness Product?

For purposes of the guidance, “general wellness products” are defined as products that:

  •  (1) Are intended for only general wellness use, as defined in this guidance and;
  •  (2) present a very low risk to user safety

General wellness products can include exercise equipment, audio recordings, mobile apps, video games, and other products that are typically available from retail establishments (including online retailers and distributors that offer mobile apps to be directly downloaded), when consistent with the two factors above.

Scope of Guidance

The scope of guidance is limited to certain products that have either:

  •  (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 associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions

For the first category of general wellness products, the intended use do not include any reference or connection to diseases or conditions and only relate to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.

For the second category of general wellness products, the product is intended to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may either help to reduce the risk of, or help living well with, chronic diseases or conditions where it is well understood that the healthy lifestyle choice(s) may reduce the risk or impact of a chronic disease or condition.

What Is Not Included

The general wellness policy does include devices that present inherent risks to a user’s safety. If the product is invasive, involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied (such as risks from lasers, radiation exposure, or implants), raises novel questions of usability, or raises questions of biocompatibility, then the device is not covered by this draft  guidance.

Why This Is Important

As many companies develop new mobile apps the legal and regulatory landscape is consistently evolving subjecting business operations to increased regulatory risk.  Along with the FDA, the Federal Trade Commission (FTC) has also stepped up its oversight by focusing their attention on product claims and data privacy impacting brand strategy and app marketing.  Recently, skincare apps MelApp and Mole Detective have received warring letters from the FTC for claiming to help consumers detect skin cancer.  By submitting comments, you help establish a set of rules that promote business growth and consumer safety.

What You Should Do

As a small business owner/entrepreneur you should submit comments expressing your position on how the guidance will impact product development and market access.  You must submit comments by April 20, 2015.

How To Submit Comments

Submit electronic comments on the draft guidance by clicking here: Comment Now. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number: Docket No. FDA-2014-N-1039.

Full Text of Public Notice for Comment

While the information provided is courtesy of the FDA, you can learn more and read the full text on the FDA website by clicking here.

1938 is the online magazine blog for Well-Kept Beauty, formally entitled Primer.

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