Playing Games with Ingredient Names? FDA May Not Be Amused

FDA not amusedWhen we perform dietary supplement label compliance reviews, one of the most common problems we find is surprisingly simple:

The ingredient has the wrong name.

It may be a name everyone in the industry recognizes. It may be a scientific name. It may be a marketing-friendly name. It may even be the name used by the ingredient supplier.

That doesn’t necessarily make it the right name for the label.

And this isn’t just about typos.

Ingredient naming problems can come from using an abbreviation, a trademark, a familiar nickname, the wrong botanical name, an incomplete description—or simply a name that doesn’t accurately identify the ingredient being used.

So, rather than turn this into a lesson in regulatory nomenclature, let’s look at 12 ingredient-name problems we routinely see in label reviews.

The Dirty Dozen: Ingredient Names That Can Get You Into Trouble

#What we seeWhat we would useWhy it matters
1Vitamin B1ThiaminFDA specifies nutrient nomenclature. “Vitamin B1” is a permitted synonym in certain contexts, but thiamin is the prescribed nutrient name.
2Vitamin B2RiboflavinSame problem: familiar doesn’t necessarily mean the appropriate nutrient declaration.
3Vitamin B5Pantothenic acid“Vitamin B5” is commonly understood, but FDA specifies the nutrient name.
4Vitamin B9Folate“Vitamin B9” is a common shorthand, but folate is the prescribed nutrient name.
5DHADocosahexaenoic acidAn abbreviation may tell the reader what the company means without actually identifying the dietary ingredient appropriately.
6KSM-66®Ashwagandha root extractA trademark identifies a branded ingredient, not necessarily the dietary ingredient that belongs in the Supplement Facts panel.
7Ginkgo extractGinkgo biloba leaf extract (assuming leaf as the plant part used)Botanical ingredients need appropriate identification, including the plant part.
8Panx ginsengAsian ginsengStandardized common names (SCNs) found in Herbs of Commerce are required when available. This one is also part of an Import Alert.
9Berberine hydrochloride (from barberry root extract)Berberine hydrochlorideThe isolated chemical form, dietary ingredient, and source can raise different labeling questions. Don’t assume the name on the COA is automatically the name that belongs on the label.
10Stevia leaf extract (>95% Reb A)Rebaudioside AA label name needs to accurately identify what is actually in the product—not simply the plant from which the material originated. Abbreviations are also a common issue.
11TriphalaProprietary (or Triphala) Blend, with components declared by SCNs, in descending order by weight, and with plant partsFamiliar, marketing-friendly, or traditional names aren’t necessarily the required common or usual names.
12Non-GMO pumpkin seed proteinPumpkin seed proteinAncillary ingredient information that isn’t part of a common or usual name can be considered “intervening material” and generally isn’t allowed within the ingredient declaration.

Why does this happen so often?

Part of the problem is that the supplement industry has developed its own vocabulary.

Ingredient suppliers use trade names. Scientists use chemical names. Marketers use names consumers recognize. Manufacturers copy names from specifications and COAs. And companies often look at other products on the market and assume that if everyone else is using a particular name, it must be acceptable.

That’s a dangerous assumption.

The name on a supplier specification isn’t automatically the name that belongs in the Supplement Facts panel.

The name consumers recognize isn’t automatically the name FDA expects.

And the name that appears on 500 other labels isn’t automatically compliant just because it’s on 500 other labels.

Botanicals deserve extra attention.

Botanical ingredients can be particularly tricky because the declaration may need to identify the plant using the appropriate standardized common name, as well as the plant part. FDA’s labeling guidance specifically addresses the use of Herbs of Commerce for botanical terminology.

And seemingly small differences can matter. Panax ginseng and “Panx ginseng,” for example, aren’t simply stylistic variations. The botanical name needs to accurately identify the ingredient, and standardized common names should be used when available.

The same goes for extracts.

If the material in your product is a highly purified constituent derived from a plant, you can’t necessarily label it simply by naming the plant it came from.

The source of an ingredient and the dietary ingredient itself are not always the same thing.

FDA’s guidance specifically distinguishes between a dietary ingredient and an ingredient used as its source. It also permits certain constituents to be declared under a dietary ingredient.

The stevia example is a good illustration. FDA’s 2023 warning letter to Cosmax NBT USA specifically addressed a label declaring “stevia extract (leaves)” when the company’s manufacturing documentation identified the material as Stevia leaf 97% (Rebaudioside A 97%). FDA stated that when a steviol glycoside is purified to 95% or more of a single glycoside, the specific glycoside name is the common or usual name—for example, rebaudioside A.

The takeaway

Ingredient nomenclature may seem like one of the smaller details on a supplement label.

It’s not.

A label can have the right ingredient, the right amount, and the right claim—and still have a problem because the ingredient isn’t being properly identified.

Before approving an ingredient name, ask:

Is this the actual dietary ingredient?

Is this the appropriate common or usual name?

If it’s a botanical, have we identified the correct plant and plant part?

Are we using a trademark, abbreviation, nickname, or supplier name where a proper ingredient declaration is needed?

And perhaps the most important question:

Are we using this name because it’s correct—or simply because we’re used to seeing it?

Just because FDA knows what you mean doesn’t mean FDA considers it the right name.

At Dietary Supplement Experts, ingredient nomenclature is one of the many details we examine during a comprehensive label compliance review.

Because when it comes to ingredient names, “almost right” may not be good enough.

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