INC/IBC Submit Comments to USP Proposed Dietary Supplement Monograph: Grape Seeds Oligomeric Proanthocyanidins
Holly Bayne, PC, Holly Bayne Law, Washington D.C.
In August 2008, INC/IBC submitted comments to the U.S. Pharmacopoeia’s (USP’s) proposed dietary supplement monograph, Grape Seeds Oligomeric Proanthocyandins. Our position is that the proposed monograph has serious shortcoming that would greatly affect its utility as a generic industry standard. The comments are being considered by USP and will be discussed at a public meeting of USP’s Dietary Supplements Botanicals Expert Committee, to be held on October 22nd in Rockville, Maryland.
USP is an organization that sets official standards for pharmaceuticals, over-the-counter drugs, dietary supplements, botanicals and food ingredients. USP’s scientific standards are used by regulatory agencies and industry to ensure product quality, strength, composition and purity. Under the Dietary Supplement Health and Education Act of 1994, USP standards for dietary supplements and dietary ingredients, published in the United States Pharmacopeia–National Formulary (USP-NF), are legally enforceable standards.
INC and IBC, the worldwide and U.S. distributors of MASQUELIER’s Original Oligomeric Proanthocyanidins (OPCs), have extensive experience in qualifying and quantifying OPCs, and in the development of analytical methods to properly authenticate them. This makes INC and IBC uniquely qualified to participate in the further development and refinement of USP’s proposed grape seed OPCs monograph. In fact, the various methods of manufacturing and uses of the compound now sold throughout the world as MASQUELIER’s Original OPCs, were developed by Dr. Jack Masquelier, who first discovered and isolated OPCs. These manufacturing methods and uses are described in French, British and American patents dating back to 1950.
INC’s main objection to USP’s proposed “oligomeric proanthocyanidins” monograph is that the term “oligomeric” is not defined, but should be defined to include only “2 to 5 units of flavan-3-ols,” while excluding the higher polymers (n>5). This definition is vitally important because Dr. Masquelier and others have demonstrated that only the smaller proanthocyanidins (dimers, trimers, tetramers) are bioavailable and provide health benefits. That is why, in the case of MASQUELIER’s Original OPCs, the manufacturing method has been optimized to exclude the higher polymers, resulting in a highly purified, superior “Grape Seed Oligomeric Proanthocyanidins” fraction with a starting plant material to fraction ratio of 120:1. Under USP’s proposed OPCs monograph, however, the starting plant material to fraction ratio is considerably less, between 70:1 to 10:1.
In addition, we believe USP’s proposed monograph utilizes analytical methods that have significant technical shortcomings, including a proposed HPLC method that is unsuitable for the detection of OPCs, and TLC results from investigated grape seed fractions that cannot exclude adulteration. Further, USP’s proposed, but undefined Reference Standards for which the origin, extraction methods and total compositions are not provided, renders the Reference Standards arbitrary and unscientific. In light of the significant shortcomings of USP’s proposed monograph, INC and IBC have urged USP to republish a revised monograph for a second round of comments, so that stakeholders will have an additional opportunity to comment before the monograph becomes official in the USP-NF.
Review INC & IBC’s comments here.