Pyridoxamine Debate Continues; CRN Points To Ingredient’s Presence In Food

Pyridoxamine's presence in many common foods makes it exempt from 75-day premarket notification, the Council for Responsible Nutrition maintains in comments supporting the ingredient's status as a dietary supplement.

"Even if it was not marketed as a dietary supplement prior to 1994, pyridoxamine, as an ingredient of green peppers, fish, liver and common food yeasts, all of which were in the food supply in 1994, is exempt from the new dietary ingredient provisions of DSHEA," CRN states in a recent submission to FDA.

The Food, Drug & Cosmetic Act "provides that a dietary ingredient which has been 'present in the food supply as an article used for food in a form in which the food has not been chemically altered' need not comply with the 75-day notice requirements of the Act that would apply to new dietary ingredients first introduced after that time," CRN writes.

The letter responds to an FDA comment period requesting information on pyridoxamine's prior sale as a supplement or food. It was initiated following a citizen petition to stop the sale of dietary supplements containing the ingredient.

In the June 2005 petition filed by BioStratum, the company maintains that the ingredient was not marketed prior to 1994 and therefore is not "grandfathered" under the Dietary Supplement Health & Education Act.

BioStratum makes Pyridorin (pyridoxamine dihydrochloride), which was the subject of an Investigational New Drug application by the company in 1999. The IND characterizes Pyridorin as a potential therapeutic agent to slow or prevent the progression of diabetic nephropathy.

Pyridoxamine "is one of three primary natural forms of vitamin B6," CRN says. The ingredient commonly occurs in almost all foods containing vitamin B6 and is in several common foods such as fish, chicken and beef liver, whole wheat, and cooked sausages.

The trade association has surveyed its members in an attempt to locate documentation such as catalogues or product order forms which would prove that the ingredient has been marketed as a supplement in the past.

"Unfortunately, because none of CRN's members currently market a product containing pyridoxamine, it has been difficult to muster the resources that would be required to launch a full-scale search of company records that have long been in storage, if they still exist at all," the group states.

CRN has interviewed retired industry executives and others who worked in the industry during the time in question, "and several recall that pyridoxamine was marketed in dietary supplements prior to Oct. 15, 1994."

The group provides an affidavit of former CRN president Annette Dickinson, PhD.

Pyridoxamine was "unquestionably" included on the list of "grandfathered" supplements compiled by the National Nutritional Foods Association after DSHEA took effect, the group maintains.

Finally, CRN asserts that regardless of the agency's pending decision on pyridoxamine, any evidence of pyridoxamine's supplement status that is submitted in the future would have to be accepted by FDA.

"If evidence is discovered in the future that demonstrates that pyridoxamine was marketed at any time prior to BioStratum's filing of the IND application in 1999, then FDA will not be able to deny a dietary supplement company's right to reassert the dietary ingredient status of pyridoxamine at that time," CRN states.

"The provision of DSHEA is clear: pyridoxamine, or any other ingredient found in the food supply in 1994, does not lose its dietary ingredient status simply because, as science advances, the pharmacologic properties or health benefiting attributes of the ingredient become more well-known."

BioStratum maintained in recent comments to the agency that an ingredient's presence in food alone does not suffice as evidence that it is grandfathered (¹ (Also see "BioStratum Challenges Affidavit Asserting Pre-1994 Pyridoxamine Product" - Pink Sheet, 6 Feb, 2006.), p. 15).

According to the company, "circumstances must establish that in marketing a product containing such a component, a person was, in actuality, marketing the component."

- Bridget Behling