We are concerned about an increasingly common industry practice when a “me too” manufacturer incorrectly uses another company’s New Dietary Ingredient (NDI) filing to market an ingredient that is not identical. This violates the law under which we all do business, discourages ingredient companies from abiding by regulations, and has the potential to harm consumers, presenting a large threat to our industry.
Specifically, Mitsubishi Gas Chemical Co., Inc.’s ingredient BioPQQ® is the only pyrroloquinoline quinone (“PQQ”) sold in the U.S. market that has been successfully filed as a New Dietary Ingredient, and subsequently the only company selling PQQ in accordance with FDA regulations.
Passed into law in 1994, the Dietary Health and Education Act (DSHEA) unambiguously requires every manufacturer of an ingredient introduced after 1994 to file for NDI acceptance with the FDA. The FDA maintains a table of all new dietary ingredient notifications and explicitly states that:
1. “The listing of a new dietary ingredient in this table does not mean that another manufacturer can lawfully market the dietary ingredient in a dietary supplement. Each manufacturer is responsible for ensuring compliance with the Act.”
2. “Importantly, if a product containing a new dietary ingredient is marketed without the required notification, unless exempt, the product may be adulterated as a matter of law.
These regulations have two important implications as it relates to the current state of the PQQ market:
1. All PQQ other than BioPQQ® is being marketed and distributed unlawfully and in direct violation of DSHEA. Any company that purchases unaccepted PQQ material is also noncompliant.2. All nutritional supplement products containing PQQ other than BioPQQ® are considered adulterated by the FDA, creating regulatory and legal risk.
Information required for an NDI filing includes safety testing and manufacturing specifications. Proprietary manufacturing information does not need to be made public. Third party manufacturers lack information needed to manufacture the FDA reviewed ingredient and therefore cannot create an identical product. As a result safety data is not applicable to third party ingredients, potentially putting consumers at risk.
We have identified adulterated PQQ ingredients with high levels of impurities, marketed by third parties purporting to rely on Mitsubishi Gas Chemical’s BioPQQ® NDI. These materials are unrefined and have failed to demonstrate safety testing sufficient for a NDI filing and are therefore unfit for consumption. We believe that knowingly distributing adulterated material is not only unethical, but poses a liability risk to the manufacturers and the health of their customers. Such practices only undermine the credibility of our industry.
Following the laws under which our industry is regulated not only protects consumers; it also creates a level playing field in which to do business.
We also ask for your support. We welcome your comments and questions which can be directed to Kevin Duffy at 212-687-9030 or via email at email@example.com.
Tomomi Suzuki Manager BioPQQ Mitsubishi Gas Chemical America, Inc.
Masahiko Nakano General Manager BioPQQ Mitsubishi Gas Chemical Co., Inc.
Dated: August 30, 2013