"Our Lady's Tears" Brings Warning Letter to Supplement Maker

| 16 April 2014 |  By 

If you didn't know better, seeing an ingredient on a dietary supplement labeled as "Our Lady's Tears" might make you think the manufacturer's process involved forcing a woman to cry into a batch of ingredients destined for further processing.

And that, the US Food and Drug Administration (FDA) explained in a Warning Letter recently posted on its website, is a problem-for the manufacturer, that is.

FDA's 21 March 2014 Warning Letter to Florida-based Aloe Man International Corp, a manufacturer of dietary supplements, is a lengthy read. The letter spans allegations of misbranding, failure to adhere to current good manufacturing practices (CGMPs), and marketing drugs as supplements.

But buried deep within the letter is a somewhat unusual set of concerns raised by FDA.

The agency alleged that several of the company's products failed to declare the presence of ingredients present in the product by their "common or usual name."

For example, the company listed the ingredient in one product as "Our Lady's Tears," when it should have been listed as Lily of the Valley, a botanical dietary ingredient. In another case, a product was labeled as "Arismatic," Amomi" and "other herbs not mentioned." In all cases, the proper names should have been used, FDA said.

In a third case, the company failed to explain which stabilizers were used in the product.

So for supplement manufacturers, FDA's lesson is clear: If you don't want to be shedding some "tears" of your own, follow FDA regulations under 21 CFR 101.4(h):

(h) The common or usual name of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The listing of these names on the label shall be followed by statements of:

(1) The part of the plant (e.g., root, leaves) from which the dietary ingredient is derived (e.g., "Garlic bulb" or "Garlic (bulb)"), except that this designation is not required for algae. The name of the part of the plant shall be expressed in English (e.g., "flower" rather than "flos");

(2) The Latin binomial name of the plant, in parentheses, except that this name is not required when it is available in the reference entitled: Herbs of Commerce for the common or usual name listed on the label, and, when required, the Latin binomial name may be listed before the part of the plant. Any name in Latin form shall be in accordance with internationally accepted rules on nomenclature, such as those found in the International Code of Botanical Nomenclature and shall include the designation of the author or authors who published the Latin name, when a positive identification cannot be made in its absence.

(3) On labels of single-ingredient dietary supplements that do not include an ingredient list, the identification of the Latin binomial name, when needed, and the part of the plant may be prominently placed on the principal display panel or information panel, or included in the nutrition label.


Warning Letter to Aloe Man


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy