FDA REGULATORY & US MARKET ACCESS
That is what makes it difficult. There is no licence number and no pre-market review, so the responsibility for proving your product is legal sits entirely with you.
FDA REGULATORY & US MARKET ACCESS
The US market has no approval process.
That is what makes it difficult.
There is no FDA sign-off for a dietary supplement. No licence number, no pre-market review, no confirmation you got it right. The responsibility for compliance sits entirely with you, and the consequences arrive as warning letters, import refusals, retailer delistings and class actions rather than as a rejected application. Kompete builds the documentation that makes that responsibility defensible.
CANADA VERSUS THE UNITED STATES
Two systems that fail in opposite directions.
Canadian brands entering the US often assume the absence of a licensing requirement makes the market easier. The opposite is closer to true. Health Canada tells you whether your product is acceptable before it is sold. FDA tells you afterward, and the answer arrives as enforcement.
Health Canada
Pre-market licence required before sale
NPN issued against a reviewed submission
Monographs define acceptable ingredients, doses and claims
Errors surface as information requests during review
Compliance is confirmed before launch
FDA
No pre-market approval for supplements
Facility registration only, no product licence
Claim substantiation held by the company, not reviewed in advance
Errors surface as warning letters, seizures or litigation
Compliance is asserted by you and tested under scrutiny
SUBSTANTIATION FILE
The file you would hand to an inspector.
Because nobody approves your product in advance, the only defence is a file that already exists: ingredient legal status, specifications and methods, batch records, stability data, claim substantiation, and adverse event procedures. We build it as the product is developed, not after a warning letter arrives.
PILLAR 01
Product classification and pathway
The first decision determines every requirement that follows, and it is the one most often made by default rather than analysis.
Classification as dietary supplement, conventional food, medical food, cosmetic, OTC drug or device
Assessment of whether an ingredient qualifies as a dietary ingredient under DSHEA
New Dietary Ingredient notification strategy and preparation
GRAS pathway evaluation for food and beverage applications
Drug preclusion analysis where an ingredient has clinical trial history
Combination product and borderline classification assessment
PILLAR 02
Claims and substantiation
Claims are where most enforcement begins, because they are the part of your product a regulator can read without visiting your facility.
Structure function claim development and competent and reliable scientific evidence review
Disease claim assessment and identification of language that triggers drug status
FTC substantiation standards for advertising, which are stricter than FDA’s for labels
Required disclaimer placement and formatting
Marketing, website and social media review including influencer and affiliate content
Claim substantiation dossiers prepared to survive an FTC inquiry
PILLAR 03
Labeling and facility compliance
Label defects and cGMP findings account for the majority of warning letters issued to supplement companies.
Supplement Facts and Nutrition Facts panel construction and verification
Ingredient declaration, allergen labeling and net quantity statements
Facility registration under the Bioterrorism Act and biennial renewal
21 CFR Part 111 cGMP gap assessment and readiness review
Master manufacturing records, batch records and specification systems
Serious adverse event reporting procedures and complaint handling
PILLAR 04
Import, supply chain and post-market
Most Canadian brands meet FDA at the border rather than in a hearing room.
Prior notice filing and import entry documentation
Foreign Supplier Verification Program requirements for imported ingredients
Import alert and detention without physical examination response
Supplier qualification and certificate of analysis review programs
Recall planning, reportable food registry and post-market surveillance
Warning letter and FDA Form 483 response preparation
MOST CANADIAN BRANDS MEET FDA AT THE BORDER, NOT IN A HEARING ROOM
GRAS IS CHANGING
The self-affirmed pathway is on the clock.
On August 11, 2026, FDA published a proposed rule that would replace the voluntary GRAS notification program with a mandatory one, amending 21 CFR parts 170 and 570. It covers substances added directly to food and substances that migrate into food from packaging. Public comments close December 9, 2026, which means the rule will not be finalized before 2027. If finalized as proposed, it takes effect 60 days after publication, with an 18-month compliance window.
01
What it does not do
Mandatory notification is not pre-market approval. A company can still reach its own GRAS conclusion and market the substance before or during FDA review. What changes is that FDA must be told.
02
The streamlined path
For substances already in commerce under a self-affirmed conclusion, the proposal includes a time-limited streamlined submission that does not require the underlying safety data. Inclusion on the resulting public list is not an FDA determination that the use is GRAS.
03
Why files fail
A conclusion reached years ago may no longer match the ingredient as manufactured, the applications it has expanded into, or the published literature as it now stands. Dietary exposure calculations built on an older use pattern are a common weak point.
04
General recognition
A GRAS conclusion cannot rest on confidential data alone. The evidence available to the wider expert community has to be sufficient on its own, which is where dossiers built around proprietary studies tend to fall short.
None of these requirements are in effect today. The window to assess an existing file, and to comment on the proposal, is open now.
WHERE TO START
Assess the file before the rule lands.
If you hold self-affirmed GRAS conclusions on ingredients sold in the US, the useful question is not whether the original determination was sound. It is whether the evidence and documentation still support that conclusion under how the ingredient is manufactured and used today, against what FDA expects a notice to contain.
IDENTITY AND MANUFACTURE
Whether the ingredient described in the file is the ingredient currently produced, including changes to raw materials, process, source organism, purification and manufacturing site.
SPECIFICATIONS
Whether current specifications are supported by analytical data and whether the commercial material still corresponds to the test article used in the supporting safety studies.
DIETARY EXPOSURE
Whether food categories, use levels and consumption assumptions still reflect actual use, particularly where an ingredient has expanded into new applications since the original conclusion.
SAFETY NARRATIVE
Whether the literature search is current, whether newly published evidence has been assessed, and whether evidence inconsistent with the conclusion has been addressed rather than omitted.
PUBLIC AVAILABILITY
Whether enough of the supporting evidence is publicly accessible to establish general recognition among qualified experts, independent of proprietary data.
PRACTICAL REFERENCE
What actually triggers enforcement.
The pattern in FDA supplement enforcement is consistent, and almost all of it is preventable at the documentation stage.
Trigger
What it looks like
Where it is prevented
Disease claims
Warning letter citing unapproved new drug status, often sourced from a website or social post rather than the label
Claim review across every channel before launch, including affiliate and influencer content
Label defects
Incorrect Supplement Facts formatting, missing allergen declaration, misdeclared serving size
Panel construction and verification against 21 CFR 101 before artwork is printed
cGMP findings
Form 483 observations on specifications, batch records, testing or supplier qualification
Part 111 gap assessment and documentation build before an inspection, not after
Undeclared ingredients
Public notice and recall following detection of a drug analogue or unlisted active
Supplier qualification, certificate of analysis review and finished product testing
Import refusal
Detention at entry, or listing on an import alert requiring proof of compliance for every subsequent shipment
Prior notice accuracy, FSVP records and labeling verified before shipment
NDI failures
Warning letter stating an ingredient is adulterated for lack of a required notification
Dietary ingredient status assessed at formulation, not after the product is on shelf
ENGAGEMENT MODEL
Four steps to a defensible US position.
01
Classify
Determine what the product is under US law and which pathway applies, before formulation or claims are locked.
02
Assess
Review formula, label, claims, supplier documentation and facility systems against current requirements, and identify what will not survive scrutiny.
03
Build
Prepare the substantiation dossiers, notifications, specifications and procedures that support the position you are taking.
04
Defend
Stay on the file for import questions, retailer audits, FTC inquiries and agency correspondence.
No one approves it. Someone still has to defend it.
Whether you are entering the US for the first time, responding to a warning letter, or holding GRAS files that predate the current proposal, the starting point is an honest assessment of what your documentation would withstand.