USFDA Alerts
The FDA issued 9 warning letters between October and December 2013 regarding dietary
supplements. In 7 cases, the FDA alleged the products were adulterated within
the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act
(the FFDCA) [21 U.S.C. § 342(g)(1)] in that the dietary supplements were
prepared, packed, or held under conditions that did not meet current good manufacturing practice (cGMP) regulations. Under the FFDCA, a dietary
supplement is deemed “adulterated” as a matter of law unless it has been manufactured, packaged, and held under conditions in accordance with FDA’s GMP regulations at 21 C.F.R. Part 111. This means that deficiencies in process controls, missing specifications, the lack of adequate
testing, or inadequate personnel training, for example, could subject such
products to regulatory action.
A detailed
list of warning letters issued is available at the following URL: http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?qryStr=dietary+supplement&sortColumn=4+desc&Go=Go&webSearch=true.
In the “Botanical
Adulterants Monitor” our focus is primarily on accidental or intentional adulteration, i.e., the willful substitution or insertion of lower cost non-labeled
botanical ingredients, as outlined in the example below. This type of
adulteration is defined in § 402(b) of the FDC Act, which provides that a food (dietary
supplements are regulated as a class of foods in the United States) shall be
deemed adulterated if any valuable constituent has been in whole or part
omitted or abstracted, any substance has been substituted in whole or part, or
if damage or inferiority has been concealed in any manner. [21 U.S.C. §
342(b)(1)(2)(3)].
On November
21st 2013, a warning letter was issued to Raw Deal, a supplier of
ingredients and proprietary formulas to the botanical, dietary supplement, pharmaceutical, and food industries. The FDA warning letter arose from an inspection of
the company’s manufacturing facility during April and May 2013, and review of production records, including batch records, customer formulation
specifications, product labels, and ingredient lists for blends, (e.g.,
Pre-mix, Allergy 1:1 Herb Blend, and Menopause Blend). According to FDA,
review of the company’s records during the inspection revealed that
maltodextrin (and/or white rice [Oryza sativa, Poaceae] powder) was used as an ingredient in the blends, but the formula specifications provided to Raw Deal by customers did not include such ingredients. Also, ingredient lists provided by Raw Deal to its customers with
shipments of the dietary ingredient blends did not list maltodextrin in the ingredient list. Therefore, FDA asserted the products were adulterated because
ingredients used to manufacture the blends had been substituted in whole or
part. The FDA also cited the following violation: “Dong Quai [Angelica sinensis, Apiaceae] Powder was
substituted for Angelica Dahurica [A.
dahurica] Root, Orange Peel [Citrus
sinensis, Rutaceae] was
substituted for Immature Tangerine Peel [C.
reticulata], and Epimedium [Epimedium
spp., Berberidaceae] PE [powdered extract] 10% was
substituted for Ledebouriella [Saposhnikovia
divaricata, Apiaceae] Root.”
Comment: Findings such as these emphasize the
necessity for all companies involved in the supply, manufacture, and distribution of dietary ingredients and dietary supplements to independently verify the identity, purity, strength, and composition of raw materials and
finished blends. Additionally, brand holders working with contract manufacturers or ingredient suppliers must exercise proper due diligence and
oversight, which should include, but not be limited to, on-site audits and
records inspection, to ensure ingredients and finished products meet
specifications. Also, FDA’s Part 111 regulations require manufacturers of dietary supplements to conduct at least one appropriate test or examination to
verify the identity of any component that is a dietary ingredient. The
manufacturer cannot rely solely on the certificate of analysis from the vendor
and must re-confirm identity, even if a thorough vendor audit and qualification
has been carried out.
For more
information: http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm377077.htm
