Regulatory Compliance Path

Selling as a traditional fermented food product without health claims. This is both the correct legal positioning and the honest one — the product is food.

The Regulatory Fork

Path A — Dietary Supplement

Registration: DSHEA (Dietary Supplement Health and Education Act, 1994)
Claims: Structure-function claims permitted with specific disclaimer ("This statement has not been evaluated by the FDA...")
Manufacturing: 21 CFR Part 111 (dietary supplement GMP)
Expensive, burdensome, requires specific labeling regime
Not appropriate — the product is a fermented food, not a concentrated extract

Path B — Conventional Food (Correct Path)

Regulation: 21 CFR Parts 100–199 (food standards)
Claims: No structure-function or health claims without specific FDA authorization
Manufacturing: 21 CFR Part 117 (food GMP for human food)
The honest positioning: a fermented food product
Significantly simpler compliance path

Key Food Safety Regulations

21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (FSMA)

Requires: Written food safety plan, hazard analysis, preventive controls
Applicable to: All food facilities with >$1M annual sales (Qualified Facility exemption below this threshold)
For a small startup below $1M: Qualified Facility status with modified requirements
Still requires: Basic sanitation, allergen controls, pest control, equipment maintenance

pH and Water Activity Controls (LACF Regulations for Acidified Foods)

This is the critical compliance issue for lactofermented products.

The FDA distinguishes between:

Fermented foods (naturally acidified through microbial activity): not regulated as "acidified foods"
Acidified foods (acid added to reach target pH): 21 CFR Part 114 — requires process filing with FDA

A genuine lactoferment (where the pH drop is produced entirely by microbial lactic acid production, not added acid) is classified as a fermented food, not an acidified food. This is the correct classification for this product.

Documentation required:

pH monitoring records showing gradual pH decrease consistent with fermentation (not an immediate drop from added acid)
Evidence that the pH reduction is microbially produced
Final pH ≤4.6 (which prevents Clostridium botulinum growth — the primary safety concern in low-acid food production)

Target pH of 3.2–3.8 is well below the 4.6 safety threshold.

Allergen Labeling (21 CFR Part 101.4)

The formulation contains potential allergens:

Celery (European allergen, not US top 9)
Wheat germ — contains gluten; must be labeled as containing wheat (US top 9 allergen)
Review full botanical list against FDA's top 9: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybean, sesame

Sesame (added to top 9 in 2023) — check botanical pack for sesame content.

Label Requirements

Required on label:

Product name
Net weight
Ingredient list (all ingredients, in descending order by weight, including all botanicals)
Manufacturer name and address
Nutrition Facts panel (can use simplified format for certain products)
Allergen declaration

Prohibited without authorization:

Disease claims ("helps with MCAS")
Unapproved structure-function claims tied to body parts or physiological conditions
Anything implying the product treats, cures, prevents, or mitigates a disease

Permitted:

"Traditional fermented preparation"
"Small-batch, 120-day fermented"
List of ingredients as botanicals
"May contain histamine" advisory for MCAS-relevant customers (voluntary but valuable)

State-Level Requirements

Some states have additional requirements for cottage food vs. licensed food production:

Check state health department requirements before selling
Most states require licensed commercial kitchen for products sold through retail channels
Direct-to-consumer (farmer's market, farm stand) has different requirements by state

Honest Representation vs. Health Claims

The protocol's complete mechanistic framework can be shared with customers in educational contexts (website, articles, books, one-on-one conversations) without violating the labeling prohibition. The label itself contains no health claims; the education happens elsewhere.

Connections

[[Product Concept]] — what's being sold
[[Economics]] — the financial model
[[Petition Framework]] — the regulatory work this preparation supports
[[System Architecture]] — the GMP-compliant production system