Getting started

Is this for you at all

Updated October 2026

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The category exists on purpose The manufacturing rule is the part people miss The claims rule is the part people break It attracts attention Who it suits What this property covers References

Anybody can buy bottles and extract. Very few of the people who do are operating inside 21 CFR 111, and the gap between those two facts is this whole property.

The category exists on purpose

Congress created a space between food and drug where a product may make claims about how it affects the structure or function of the body without being approved as a medicine. That is a genuine commercial advantage and it comes with a manufacturing rule and a claims rule attached.

The manufacturing rule is the part people miss

A dietary supplement manufacturer operates under current good manufacturing practice: written procedures, identity testing of incoming ingredients, batch records, specifications you set and then meet. A jam maker has none of that. Somebody bottling tinctures on a kitchen table usually does not realize they are in it.

The claims rule is the part people break

You may say what a product does. You may not say what it treats. That line is narrower than it sounds, it is enforced, and it is broken most often by enthusiasm rather than dishonesty: a testimonial, a blog post, a reply to a customer question.

It attracts attention

This is a category with a long enforcement history and a lot of it is about claims rather than contents. Warning letters in this space quote websites and social posts as readily as labels, which is a thing to understand before you start writing marketing copy.

Who it suits

Somebody comfortable with documentation and disciplined about language. The formulation is usually the easy part; the records and the wording are the work, and they are the parts that determine whether the business survives scrutiny.

What this property covers

The claims line and the disclaimer, the Supplement Facts panel, what cGMP actually asks for, and the container decisions for a small dark dropper bottle. It does not formulate anything, and it is not legal advice on your specific label.

References

21 CFR 101.93, Certain types of statements for dietary supplements, which carries the disclaimer word for word and the requirement to notify FDA within 30 days of first marketing a product bearing a structure/function statement. law.cornell.edu

21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. law.cornell.edu

Written from federal regulation, not from a laboratory and not from a lawyer. The claims rules here are specific and strictly enforced, and the difference between a permitted statement and a drug claim is narrower than it looks. Treat anything here as a starting point for advice on your own label rather than as clearance for it.