Warning letter underscores FDA view of extraction and concentration as factors in NDI status

By Hank Schultz

- Last updated on GMT

Related tags New dietary ingredient

Warning letter underscores FDA view of extraction and concentration as factors in NDI status
A warning letter from FDA to Star Scientific, makers of an antioxidant supplement called Anatabloc, underscores again the agency’s focus on the status of New Dietary Ingredients.

In the warning letter​, FDA outlines what it considers to be some key errors the company made in the development of the supplement that is based on a molecule called anatabine, which can be found in low levels in a variety of plant sources. Star Scientific has not filed an NDI notification on this ingredient, which the agency says it should have.

“They are definitely ramping up the new dietary ingredient warning letters,”​ attorney Ivan Wasserman told NutraIngredients-USA.  Wasserman is a partner in the Manatt law firm.

If you extract it, it's new

This warning letter goes a step beyond some other recent warning letters that have mentioned the NDI issue, Wasserman said. Many of these past letters involved DMAA and centered on the issue of whether this ingredient was a lawful dietary ingredient in the first place, with the agency maintaining that it is wholly synthetic.  In the case of anatabine, the agency is not quibbling over the compound’s botanical origin.  But the agency’s view the molecule’s presence at very low levels in foods does not automatically confer Old Dietary Ingredient status to the ingredient when it is extracted and presented at a high concentration, Wasserman said.  To qualify for this grandfathered status, a substance must meet some very specific requirements, he said.

“FDA's position (is) that just because an ingredient is a constituent of a food (e.g. a substance in a fruit or vegetable) that does not necessarily mean it is ‘present in the food supply’ and thus not require a new dietary ingredient notification (NDIN).  The ingredient itself must have been ‘used for food,’ ”​ Wasserman said.

The key point for falling under the grandfather clause of DSHEA is whether an ingredient was being marketed as a food as of Oct. 15, 1994.  As far as anatabine is concerned, the agency’s position is unequivocal:

“Although anatabine occurs naturally in certain foods such as cauliflower, eggplant, potatoes, and tomatoes, the mere presence of anatabine in such foods, without any evidence that the foods were promoted for their anatabine content, does not constitute 'marketing' of anatabine as a food,”​ the agency wrote in the letter.

“Because the required premarket notification was not submitted to FDA, your products containing anatabine are deemed to be adulterated,”​ the agency concluded.

IND roadblock

Star Scientific started marketing Anatabloc as a supplement in August 2011, according to the letter.  The company subsequently filed an Investigational New Drug application on anatabine in July, 2012.  This pathway, starting first as a lawfully-marketed supplement and then moving on to a drug, is approved by the agency, but not the other way around. This is the second mistake Star Scientific made, according to the agency.  Because there is no NDI notification on anatabine, the supplement is considered adulterated and therefore not lawfully marketed.  So, with an IND application on file for the molecule, Star cannot now market it as a supplement, unless they successfully petition the agency to be allowed to do so, Wasserman said.

“To the best of FDA’s knowledge, there is no information demonstrating that anatabine was marketed as a food prior to being authorized for investigation as a new drug under an IND,”​ the agency wrote.

“Assuming FDA sticks to this position they would have to file a petition to continue marketing the supplement,”​ Wasserman said.

Disease claims

FDA also cited the company for unapproved disease claims relating to research on the substances effects on ulcerative colitis, multiple sclerosis, Alzheimer’s disease and traumatic brain injury.  In addition, the agency warned Star Scientific for unapproved disease claims contained in consumers’ testimonials featured on a company website.

“The company is responding to the letter and has already advised the agency that it intends to work cooperatively to resolve these issues, including undertaking a review of the company's websites,”​ said Star Scientific in a statement.

Star Scientific has been under pressure since the disclosure last year of thousand of dollars of gifts and loans from former CEO Jonnie R. Williams and the company to Virginia Gov. Bob McDonnell and members of his family.  According to the Washington Post, state and federal authorities are investigating the transactions.  Williams recently stepped down as CEO but will remain with the company in an official capacity for the next year. 

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1 comment

Why does FDA use the term premarket approval in paragraph #2?

Posted by D. MacKay,

I also noted a an interesting sentence in the warning letter - "In addition, your Anatabloc and CigRx products contain anatabine as a dietary ingredient. While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket approval."

Note the use of "premarket approval" in this sentence. Does anybody have insight on why FDA used "approval" and not "notification"?

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