The short answer
Probiotics are sold in the U.S. in two very different ways:
- As foods — yogurt, kefir, kombucha, fermented drinks, snack bars with added cultures. Each added microorganism must be GRAS (or an approved food additive) for that use, and the product follows normal food labeling.
- As dietary supplements — capsules, powders, gummies. The cultures are dietary ingredients; a strain not sold in U.S. supplements before October 15, 1994 may need a New Dietary Ingredient (NDI) notification. FDA has reviewed NDI notifications for live microbial ingredients.
CFU labeling on supplements
Supplement Facts rules require the amount of each dietary ingredient by weight. FDA’s September 2018 draft guidance (docket FDA-2011-D-0376) says it intends to use enforcement discretion to let firms also declare colony forming units (CFU), if:
| Condition | What it means on the label |
|---|---|
| Weight first | The quantity is still declared by weight first |
| Clearly separate | CFU shown separately — for example in parentheses or a sub-line: “100 mg (10 billion CFU)” |
| Understandable | Plain terms such as “10 billion”, with the unit clear |
| Live only | The CFU count measures live microorganisms only, not dead or inactive ones |
| Accurate | Not misleading; in a proprietary blend, cultures listed in descending order by weight |
Claims
- Structure/function claims such as “supports digestive health” are allowed on supplements with the FDA disclaimer and notification within 30 days of marketing. See supplement labeling.
- Disease claims — “treats IBS”, “prevents diarrhea”, “cures infections” — make the product a drug, whether food or supplement.
- Probiotics marketed for infants or for use in hospitals deserve extra care; FDA has warned about serious infections in preterm infants given probiotic products.
Checklist
- 1Decide food or supplementThis decides GRAS vs NDI, Nutrition Facts vs Supplement Facts and which GMP applies.
- 2Name each strainGenus, species and strain on the label and in your specifications.
- 3Check the regulatory status of each strainGRAS notices for foods; history of use or NDI for supplements.
- 4Test and support the countStability studies supporting the CFU claim through shelf life.
- 5Register and shipFDA food facility registration with a U.S. Agent, Prior Notice and an importer with an FSVP.
Example: probiotic capsules from Denmark and kefir from Poland
A Danish company exports capsules with two Lactobacillus strains. Its Supplement Facts reads “Probiotic blend 150 mg (20 billion CFU*)”, with the asterisk explaining the count at expiry, and the label makes only “supports digestive health” with the FDA disclaimer. A Polish dairy exports kefir: the cultures are part of a traditional fermented food, the label follows normal Nutrition Facts rules and declares milk, and it makes no disease claims.
Standard label review (Supplement Facts or Nutrition Facts, structure/function claims) $550. FDA facility registration with U.S. Agent from $300. FSVP program from $400 per supplier.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
Can I list CFU on a US supplement label?
Yes, under FDA’s enforcement discretion, as long as the weight is declared first and the CFU count is separate, clear, accurate and measures only live organisms.
Do probiotic strains need FDA approval?
There is no approval, but foods need each strain to be GRAS for its use, and supplements may need an NDI notification for strains not marketed before October 15, 1994.
Can a probiotic claim to treat IBS?
No. That is a disease claim and makes the product a drug.
Is the CFU guidance final?
It was issued as a draft in September 2018. FDA said it intends to exercise enforcement discretion as described.
Sources
- FDA — Draft guidance: Quantitative labeling of dietary supplements containing live microbials (September 2018)
- FDA — Guidance page (docket FDA-2011-D-0376)
Rules checked on November 12, 2026. This article is general information, not legal advice.