The Watchtowers: The Distinct Roles of FDA & FTC

The Audit: FDA vs. FTC Jurisdiction

1. FDA: The Guardian of the Product

The Food and Drug Administration (FDA) is concerned with the Material Reality of the supplement. Their primary weapon is 21 CFR Part 111 (Current Good Manufacturing Practices). They inspect facilities to answer physical questions:

• Is the "Ashwagandha" actually Ashwagandha? (Identity Testing)
• Is it free from Heavy Metals and Microbes? (Purity Testing)
• Does the "Supplement Facts" panel accurately reflect the contents? (Composition)

The FDA also regulates the Label itself. If a label claims to cure cancer, the FDA intervenes because the product is being sold as an unapproved drug.

2. FTC: The Guardian of the Speech

The Federal Trade Commission (FTC) is concerned with the Persuasive Reality. They monitor what is said about the product in the public sphere. Their standard is "Truth in Advertising."

The FTC demands Substantiation. If a company claims a product "Boosts Memory," they must possess "competent and reliable scientific evidence" to back that claim before they make it. The conflict often arises here: You can share a scientific study (First Amendment/Free Speech), but you cannot use that study to sell a product if the FTC deems the evidence insufficient for the specific claim being made (Commercial Speech).

3. Decoding the "Warning Letter"

When the media reports that "The FDA issued warning letters to supplement companies," the public often assumes the products were poisonous. This is rarely the case. Most Warning Letters are issued for Linguistic Violations.

If a company uses the word "Inflammation" (a medical pathology) instead of "Normal Inflammatory Response" (a physiological function), they are technically selling an "Unapproved New Drug." The herb inside the bottle may be pristine and safe, but the language used to describe it violated the boundary between Food and Drug.