When 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 see	What we would use	Why it matters
1	Vitamin B1	Thiamin	FDA specifies nutrient nomenclature. “Vitamin B1” is a permitted synonym in certain contexts, but thiamin is the prescribed nutrient name.
2	Vitamin B2	Riboflavin	Same problem: familiar doesn’t necessarily mean the appropriate nutrient declaration.
3	Vitamin B5	Pantothenic acid	“Vitamin B5” is commonly understood, but FDA specifies the nutrient name.
4	Vitamin B9	Folate	“Vitamin B9” is a common shorthand, but folate is the prescribed nutrient name.
5	DHA	Docosahexaenoic acid	An abbreviation may tell the reader what the company means without actually identifying the dietary ingredient appropriately.
6	KSM-66®	Ashwagandha root extract	A trademark identifies a branded ingredient, not necessarily the dietary ingredient that belongs in the Supplement Facts panel.
7	Ginkgo extract	Ginkgo biloba leaf extract (assuming leaf as the plant part used)	Botanical ingredients need appropriate identification, including the plant part.
8	Panax ginseng	Asian ginseng	Standardized common names (SCNs) found in Herbs of Commerce are required when available. This one is also part of an Import Alert.
9	Berberine hydrochloride (from barberry root extract)	Berberine hydrochloride	The 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.
10	Stevia leaf extract (>95% Reb A)	Rebaudioside A	A 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.
11	Triphala	Proprietary (or Triphala) Blend, with components declared by SCNs, in descending order by weight, and with plant parts	Familiar, marketing-friendly, or traditional names aren’t necessarily the required common or usual names.
12	Non-GMO pumpkin seed protein	Pumpkin seed protein	Ancillary 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 “Asian 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.

By Curtis Walcker, M.S.
January 24, 2021

In 2020, we saw 20 FDA Warning Letters posted citing label violations for dietary supplements. We tallied up all of the violations cited and put them into a single chart. For the most part, these are the same violations we see year after year. However, there were a few things worth taking note of. Here is what we found:

What was familiar?
We do tracking and compiling of FDA Warning Letters each year, and with regard to label violations, everything was pretty familiar. FDA was able to grab the same old low-hanging fruits that brands still find challenges with. As with years previous – incorrect common or usual names, missing plant parts for botanicals, missing ingredient declarations, and incorrect use of bars and hairlines topped the chart with very high numbers. Things like zero claims, intervening material, and the use of footnotes that should not be present can typically be traced back to brands trusting the templated system-generated Supplement Facts panels supplied to them by their manufacturers, or worse – copying competitor labels. No matter what the reason behind errors, the Warning Letters get addressed to the brand on the bottle, and not manufacturers or competitors. Shoring up label compliance is definitely one of the fastest and easiest risk-reducers for any brand.

How did our client labels compare?
New client labels were very similar in terms of what issues we resolved, and frequency in which they occurred. The great thing that occurs with returning or existing clients is that within a few labels together, the client begins removing template errors across all of their labels proactively, so our reviews become more streamlined and focused on product-specific errors. For instance, once a client figures out that they were missing serious adverse event reporting information on a couple of labels, they go back and put it onto all labels.

What stuck out?
More than anything, this is why we track Warning Letters and violations the way we do. You can go read the laws and regulations all day long, but Warning Letters shed light on what the FDA is focusing on, and how they are interpreting things. While nothing was really new here, beyond the usual violations, these three stuck out:

1. Trade names are not permitted within the Supplement Facts panel.

   This may come as a big surprise to virtually all brands…and manufactures…and raw material suppliers. However, it is the case. The information panel of a label generally bears the Supplement Facts panel, ingredient statement, and name/place of business, and major food allergen labeling when applicable. All of these items are regulated in terms of their contents, placement, and formatting. Adding anything beyond what is required, becomes at risk of being what the regulations refer to as “intervening material”. And anything intervening and not required by the regulations is generally not allowed.

   In the Warning Letter to Market America, Inc. for instance, FDA noted to them that referencing their trademarked ingredients (SunActive® and Quatrefolic®) within the Supplement Facts panel was not permitted – referring to it as intervening material.

   This does create a bit of a conundrum. A brand invests more into their product with trademarked ingredients, and they want to let their consumers know. However, for FDA compliance, the Supplement Facts panel should not be that marketing vehicle. There are many other places more suitable on the label or in the labeling for marketing callouts.

2. “Herb” and “aerial parts” are not acceptable plant parts to declare for botanicals.

   Again, probably surprising to a lot of brands. We see this come through on labels weekly. Plant part(s) declared for botanicals need to be specific. Understandably, FDA told R-Garden, LLC that “Cleavers herb” was inadequate, as “herb” is not a plant part. Less understandable, however, ForYou, Inc. and BHP Holdings, Inc. were told that “aerial parts” was also inadequate. The industry tends to use “aerial parts” when plant parts used consist of all parts above ground – much like “whole plant” is used when all parts are used. The challenge in labeling aerial parts one-by-one is that the lists could become long and ultimately be more misleading when parts are left out of the list. This is one we’d like to see some more clarity from the FDA on what exactly they are looking for.

3. If a footnote in the Supplement Facts panel is not required, it is not allowed.

   This one is usually just a template error, usually passed along by a manufacturer, but a risk nonetheless. We see many Supplement Facts panels with both of the typical footnotes, “Daily Value not established” and “Percent Daily Values are based on a 2,000 calorie diet”. However, either one is only required and only allowed when it applies based on what is declared. FDA let LifeHealth Science know this, when they sent them a Warning Letter stating that their footnote was not permitted, as nothing declared required it.

If you recognize any of these errors in your own labels, or are unsure, we are here to help. We offer very affordable label compliance review service, fast turnaround times, and bulk discounting for multiple labels. Contact us today!