Question 1

Do dietary supplements need FDA approval before sale?

Accepted Answer

No. Under DSHEA, dietary supplements are a subcategory of food. FDA does not pre-approve finished supplements, formulas, or structure-function claims. You still must register the facility, appoint a U.S. Agent if you are foreign, label the product correctly, file NDI notifications when required, and meet 21 CFR Part 111 cGMP. Registration and a U.S. Agent are not FDA approval of the product.

Question 2

Must a foreign supplement factory register as a food facility?

Accepted Answer

Yes. Owners, operators, or agents in charge of a foreign facility that manufactures, processes, packs, or holds food — including dietary supplements — for U.S. consumption must register under 21 CFR 1.225, using Form FDA 3537 in FURLS, unless an exemption in 21 CFR 1.226 applies. Register before those activities begin (21 CFR 1.230). A facility without a current registration cannot lawfully export that food to the United States.

Question 3

When is the next food facility biennial renewal?

Accepted Answer

1 October through 31 December 2026, then every even-numbered year in that same window (21 CFR 1.230(b)). There is no grace period. If you do not renew, the registration is no longer current and food from the facility is adulterated under 21 CFR 1.241. Shipments can be detained or refused. Axentra calendars the window and files the renewal in FURLS.

Question 4

Is the U.S. Agent the same as the FSVP importer?

Accepted Answer

No. The U.S. Agent is the FDA point of contact named on the foreign facility’s Form FDA 3537 (21 CFR 1.227 and 1.232). The FSVP importer is the U.S. owner or consignee responsible for verifying the foreign supplier under 21 CFR Part 1, Subpart L. They are different roles, often filled by different firms. Appointing Axentra as U.S. Agent does not, by itself, satisfy FSVP.

Question 5

What is an NDI and when do I file?

Accepted Answer

A New Dietary Ingredient is a dietary ingredient not marketed in the United States before 15 October 1994. Before marketing a supplement that contains an NDI, the manufacturer or distributor must submit a notification to FDA at least 75 days in advance (21 CFR 190.6). FDA’s letter is an acknowledgment or an objection, not an approval. Many foreign botanicals and concentrated extracts require this filing.

Question 6

What goes on a Supplement Facts panel?

Accepted Answer

21 CFR 101.36 requires serving size, servings per container, each dietary ingredient by name and amount per serving, and percent Daily Value where FDA has established one. Non-dietary ingredients (excipients, fillers, capsule shells) go in a separate ingredient list by common or usual name. The product must be identified as a dietary supplement. Labeling errors are a frequent cause of import refusal.

Question 7

Do structure-function claims need FDA pre-approval?

Accepted Answer

No. 21 CFR 101.93 allows structure-function claims without pre-approval if they are not disease claims and if the required FDA disclaimer appears prominently, boxed, and in bold. You must notify FDA no later than 30 days after first marketing the supplement with that claim. Claims that the product diagnoses, treats, cures, or prevents a disease make it an unapproved drug.

Question 8

What does 21 CFR Part 111 actually cover?

Accepted Answer

Part 111 is dietary supplement cGMP — not drug cGMP (Parts 210/211) and not food preventive-controls cGMP. It covers personnel, plant and equipment, production and process controls, quality control, laboratory operations, packaging and labeling control, holding and distribution, returned and salvaged product, and complaint files. FDA inspects foreign supplement facilities. A Form 483 can lead to a warning letter or an import alert.

Question 9

Is there an FDA fee for supplement facility registration?

Accepted Answer

No. FDA does not charge a user fee to file or renew Form FDA 3537 for a food or dietary supplement facility. Axentra’s public U.S. Agent Market Access Bundle is $299 per year per facility and covers official U.S. Agent appointment, facility registration, and communications handling. Label review, NDI notifications, Part 111 gap assessments, and FSVP plans are separate engagements.

Question 10

Do I still need Prior Notice if the facility is registered?

Accepted Answer

Yes. Registration identifies the facility. Prior Notice (21 CFR Part 1, Subpart I; Form FDA 3540) identifies each incoming shipment. File Prior Notice before arrival — not more than 15 calendar days early, and not later than the mode-specific cutoff in 21 CFR 1.279: 2 hours before arrival by land, 4 hours by air, 8 hours by water. Prior Notice is not in the $299 U.S. Agent bundle (typically the importer or customs broker). A registered facility with no Prior Notice can still have the lot refused.

Question 11

How fast can Axentra file a facility registration?

Accepted Answer

Typical turnaround is 2–12 hours after we have a matching DUNS record, FDA Industry Systems access, complete facility and activity data, and a signed U.S. Agent designation. DUNS issuance for a new international entity often takes several business days and sits on the critical path before FURLS will accept the filing. We do not file incomplete or mismatched DUNS data.

FDA Dietary Supplement Compliance for Foreign Manufacturers

What we handle

Dietary Supplement FDA Compliance & FSVP— Frequently Asked Questions

When must a New Dietary Ingredient notification be filed?

Do I have to tell FDA about a structure/function claim?

Who is responsible for the FSVP — me or my importer?

Is dietary supplement FDA registration the same as FDA approval?

Do dietary supplement facilities register as food facilities?

Starting at $299 per year per facility. Labels, NDI, and FSVP quoted separately. Not an FDA fee.

Related: U.S. Agent services, food facility registration.