For years, one of the most common violations cited in FDA Warning Letters has involved missing plant part(s) declarations for botanical ingredients. Specifically, the regulations require that the part(s) of the plant (e.g., root, leaves, seeds, etc.) from which a botanical dietary ingredient is derived be declared in the Supplement Facts panel. A few compliant examples: “Garlic bulb”, “Garlic (bulb)”, or “Garlic bulb extract”. The only exception for including plant parts would be for algae.
While this violation is extremely common, it is also one of the easiest to comply with and prevent from ever becoming an issue for your brand. Raw material suppliers should be providing this critical information, it should be part of raw material specifications at the manufacturer, and should be communicated on all respective labels. However, some simplicity seems to be lost when it comes to raw materials using aerial parts, and that designation being declared on product labels.
We’ve seen “aerial parts” listed on raw material data sheets indicating all above ground parts. We’ve seen 100s of labels using that plant parts declaration, and never really batted an eye about it being inaccurate or misleading. However, a series of FDA Warning Letters in the past few years have made us question the declaration, and even advise clients about it.
Some FDA Warning Letter excerpts on this topic:
To ForYou, Inc.
Your Thin-Ergy AM and Thin-Ergy Boost products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example, the labels fail to declare the specific part of certain plants that use the term “aerial parts.”
To BHP Holding, Inc.
Your Neem Synergy and Cocktail Liposomal products are misbranded…in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived…For example, those botanical dietary ingredients that identify the part of the plant as “aerial parts” fail to specify the exact aerial parts.
To R-Garden, LLC
Your Memory Formula, Herbal Blends Eyes System, Herbal Blends Liver Gallbladder System, Milk Thistle Formula, and Herbal Blends Prostate System products are each misbranded…because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1)….For your Herbal Blends Eyes System, “aerials” are not a specific plant part.
To Marco Pharma International, LLC
Your Para A and Absinthium products are misbranded…in that each label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived…For example, your Para A and Absinthium product labels fail to declare the specific part of certain plants that use the term “aerial part” or “aerial portion”.
To Let’s Talk Health, Inc.
Your Agua Vitae “Water of Life,” Brain Booster, Prosta-Plex Plus, Diatrol Plus, and Menopause products are misbranded…because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived…The Menopause product label lists “aerial part” which is not a specific part of the plant for the alfalfa in the “Proprietary MenoRelief Complex.”
To TruVision Health, LLC
Your Complete™ Women’s Multivitamin product is misbranded…because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived…We note the term “Horsetail Extract (Aerial Parts)” does not comply with this requirement.
Given the trend in citations for declaring plant parts as “aerial parts”, “aerial portion”, or “aerials”, it would seem that brands should be more specific in their plant part declarations in order to appease the FDA. As we advised clients of this, many of the conversations that followed were almost always similar. The question back was immediately, “Well what should we put instead, if our manufacturer and raw material supplier have documentation that aerial parts is accurate?” Our response to that was muddy at best – to declare individual parts as best you can. But of course, sometimes what would come back would be too few parts (e.g., stem and leaves) to accurately represent all above ground parts, or it would be too complex to fit onto a label, where a dozen or more parts would be revealed. Nothing seemed to rival the accuracy of simply “aerial parts”.
Knowing that we’ve seen FDA review many labels listing “aerial parts”, many raw material specifications listing “aerial parts”, many MMRs and BPR listing “aerial part” without apparent issue, this was a challenging thing to comment on clearly. We have also seen FDA receive new dietary ingredient notifications for botanicals using aerial parts, and find “aerial parts” listed as a plant part in FDA’s Botanical Drug Development guidance document. And then we saw the recent Warning Letter sent:
To Western Herb Products, Inc.
Your Wormwood/Aloes dietary supplement is misbranded…in that the labels fails to identify the appropriate part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example:
a. The label indicated that Artemisia absinthium is derived from the leaf part of the plant, however, the specification sheet indicated that the botanical ingredient is derived from the aerial parts, which include the entire plant parts that grow above the ground…The plant part declared on the product label must be consistent with the actual plant part identity as indicated on the specification sheet.
Reading this section of the Warning Letter seems to indicate that FDA here recognizes “aerial parts” to mean the entire plant parts grown above the ground – and also seems to indicate that the violation could be corrected by declaring “aerial parts” on this particular label.
Going forward, unless we get some more clarity from FDA or otherwise – as long as our clients are declaring accurately “aerial parts”, we are not going to comment on it for change. This declaration does not seem to have a better alternative to match conciseness on a label.