NDI Needed In Absence Of "Concrete Evidence" Of Prior Sale – Attorney

Until FDA issues new dietary ingredient notification guidance, a company must consider several factors when deciding whether an NDI is necessary, an attorney says.

Congress mandated in last year's food safety bill that FDA issue guidance within 180 days of President Obama signing the bill, which should be by early July (Also see "McCain-Dorgan NDI Guidance, Steroid Provisions In Senate Food Safety Bill" - Pink Sheet, 29 Nov, 2010.).

The agency "has indicated that they're hoping to get it out before July," said Claudia Lewis-Eng, a partner at the Washington law firm Venable.

An NDI May Be Necessary If:

• There is no concrete evidence an ingredient was in the food supply.

• An extract of a grandfathered ingredient has been chemically altered.

• The ingredient is a different part of an herb or botanical than the grandfathered ingredient.

• A different company already has an NDI.

But until that happens, "it's not very clear when something is a new dietary ingredient," she said at a Food and Drug Law Institute conference Jan. 27 in Washington.

"The good news is that FDA really hasn't been taking enforcement actions on new dietary ingredients recently, so the industry at large had a little bit of a reprieve," she said.

The agency acted last year against aromatase inhibitors that went to market despite failed NDIs (Also see "FDA Enters New Enforcement Territory With Warnings Against Failed NDIs" - Pink Sheet, 18 Oct, 2010.).

In general, a new dietary ingredient notification is not required for products that were marketed legally as supplements in the U.S. before Oct. 15, 1994, or for dietary ingredients that were "present and marketed in the food supply as an article used for food before 1994," she noted.

One key factor to consider when debating whether to submit an NDI is whether sufficient evidence to support that an ingredient was marketed prior to the grandfather cutoff exists. If there's no evidence, the agency takes the position that an NDI is required, she said.

The agency is looking for "concrete evidence" like bills of lading, websites or circulars, she said. "There was a recent case where the agency said that affidavits from those who sold the product were not adequate evidence," she warned.

If a company wants to produce an extract of a food, that probably does not require an NDI if the food was in the food supply – like green tea or cinnamon – before the 1994 cutoff.

"The only time that you need a submission is if you're chemically altering that extract in some way," she said.

It might be a different case, though, if a company wants to include a different part of an herb or botanical than the one that had been used – the root of an herb when the leaves had been used, for example.

"It can be expensive, and it takes time for the agency to review," she said. "But better to have an NDI notification on file than not to have one on file."

In other cases, an ingredient may have been in the food supply prior to the grandfather cutoff, but not in the U.S. The statute says supplements must have been in the domestic food supply, but the food component clause does not have that restriction, she said.

"It's been our position that as long as you can establish it's been in the food supply someplace in the world, then it is not necessarily a new dietary ingredient," she said.

The American Herbal Products Association and Council for Responsible Nutrition keep lists of ingredients that have been submitted for NDIs, she said.

Although the lists are "fairly reliable," FDA does not deem them official, she said. "So the agency can always take exception to the product that's on the list," she warned. Lewis-Eng said she urges clients to "do due diligence" and find out what criteria the association used for listing the ingredient as not requiring an NDI.

Additionally, she noted that unlike health claims, which can be used by the whole industry, NDIs only cover the company that submitted them.

There have not been as many NDI notifications filed as there should be, she said.

Only 34 were filed in 2009, and the agency rejects 75% of applications, AHPA said last year (Also see ""Insufficient Data" Linked To Most NDI Notification Failures At FDA" - Pink Sheet, 8 Nov, 2010.).

A successful NDI submission includes the name of the company and contact information, the name of the ingredient and its history of safe use.

"The toxicity and safety data are the most important element," she said, and urged companies to have a toxicologist review the safety data.

An agency official warned last year that, once guidance is issued, FDA will not warn companies that fail to comply before taking judicial action (Also see "FDA Will Enforce NDI Notification Requirement Without Warning" - Pink Sheet, 21 Jun, 2010.).

By Carolyn B. Phenicie