The US FDA draws a hard regulatory line between food and dietary supplements. Products that add non-standard ingredients (botanicals, vitamins, minerals) to conventional foods, or that make health-related claims, are treated as supplements and subject to a separate, more demanding compliance regime. A June 2025 FDA rule update — the first since 2010 — has tightened enforcement significantly, increasing the practical risk of importing functional food products without proper supplement registration.
This article summarises the key rules, the specific violations that trigger FDA action, and the strategic options available to brands navigating this landscape.
The FDA issued its first food labelling rule update in 15 years in June 2025. Key enforcement changes include:
The practical effect is that products which may have passed through customs without issue in prior years now carry a materially higher risk of FDA action.
Evidence: This rule change was the direct trigger for La Natura's inability to import their functional coffee range under existing food classification. See [1].
The FDA defines certain products as standard foods — categories with a fixed, expected composition. Coffee is one such standard food.
Adding the following to a standard food is prohibited under food regulations:
If such ingredients are present, the product cannot be lawfully marketed as a food — it must be classified and registered as a dietary supplement.
Making any of the following types of claims on a food product is not permitted:
| Claim Type | Examples |
|---|---|
| Longevity / anti-aging | "Longevity coffee," "supports healthy aging" |
| Cognitive function | "Focus," "mental clarity," "brain health" |
| Skin / beauty | "Good for your skin," "collagen support" |
| General health benefit | Any structure/function claim tied to an added ingredient |
To make these claims lawfully, the product must be registered and sold as a dietary supplement, not a food.
Note: Watered-down descriptive names (e.g. "Focus Coffee" as a brand name rather than a health claim) may be permissible, but this is a grey area and should be reviewed on a case-by-case basis.
Many brands on platforms like Amazon do make aggressive claims on food-classified products. The practical enforcement model is:
This means non-compliance is possible to sustain temporarily, but it is not a stable long-term position and carries the risk of forced product withdrawal.
| Dimension | Food | Dietary Supplement |
|---|---|---|
| Health claims | Not permitted | Permitted (with caveats) |
| Non-standard ingredients | Not permitted in standard foods | Permitted |
| Factory registration | Standard food facility registration | Supplement manufacturer registration required |
| Audit requirement | Standard | Yes — can take 6–9 months |
| FDA registration cost | Standard | ~$200 |
When a product range cannot be lawfully imported as food, three paths are available:
Register the manufacturing facility as a supplement manufacturer with the FDA.
Import the functional range as food and make marketing claims, accepting the regulatory risk.
Incorporate a new US company specifically for the functional/supplement range, keeping it legally separate from the core brand.
Example: La Natura considered creating "La Natura Supplements" as a separate US entity to ring-fence their functional coffee range from their core coffee business. See [1].
Standard food products without added functional ingredients or health claims are generally unaffected by these rules:
The compliance burden applies specifically to products where non-standard ingredients are added and/or health claims are made.