Recently the FDA sent out reminders to food processors regarding labeling guidance for Medical Foods. The guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this particular topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Spoiler alert: Don’t make medical claims on your labels! If you are, you shouldn’t be, no matter how awesome your product might be, it will violate the regulations set forth by the FDA.
You can read the FDA GUIDANCE HERE
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