Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

Morrison & Foerster LLP
Contact

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt to provide some regulatory clarity in the wake of the explosion in popularity of wearable wellness devices and general fitness products. The draft guidance — which slightly loosens the FDA’s hold on general wellness products — comports with the FDA’s current policy of refocusing its resources on high - risk products and away from products that present low risk to the end - user.

BACKGROUND -

Historically, the FDA has not regulated devices intended to benefit a user’s overall health and wellness, unless those products made claims about disease prevention, treatment, mitigation, or cure. In the FDA’s prior guidance of 1995, it stated that it would regulate fitness equipment only if the equipment was “intended to be used for medical purposes[.]” On the other hand, if the equipment was to be used for “general physical conditioning,” the equipment was outside the FDA’s regulatory scheme.

Please see full publication below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP | Attorney Advertising

Written by:

Morrison & Foerster LLP
Contact
more
less

Morrison & Foerster LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide