Pallone Bill On New FDA Regime for Nutraceuticals Sparks Debate

FDA Week

A nutraceutical bill recently introduced by Rep. Frank Pallone (D-NJ) which would set up an entirely new FDA regulatory regime for nutraceuticals has sparked debate over how FDA should regulate food-type products with health benefits, and has prompted sharp criticism from several dietary supplement makers. The bill would establish nutraceuticals as a new regulatory category falling between drugs and dietary supplements, and would provide companies gaining FDA approval for health claims with 10 years of market exclusivity in an attempt to stimulate research.

Dietary supplement lawyers are attacking the bill for being badly written, too narrow, and possibly leading to a slippery slope which would end with reopening the Dietary Supplement Health Education Act (DSHEA). FDA appears nervous about the prospect of defining certain drug-like products as nutraceuticals, but the agency’s official position on the bill was unclear at press time (Nov. 4).

The bill, introduced Oct. 1, would set up a premarket approval system for nutraceuticals that is potentially less stringent than that applied to new drugs but significantly more stringent than that applied to dietary supplements. In exchange, companies gaining FDA approval would receive 10 years of market exclusivity. The term nutraceutical would cover dietary supplements, foods, or medical foods that: 1. possess health benefits, defined as reducing the risk of a disease or health condition, including the management of a disease or health condition or the improvement of health; and 2. are safe for human consumption in such quantity, and with such frequency, as required to realize such properties.

Companies would be required to conduct at least one clinical trial to gain FDA approval. Sponsors hoping to get the 10 years of market exclusivity would have to submit their information to an Advisory Council on Nutraceuticals which decides if a petition should be reviewed by FDA and if the petition conflicts with another petition.

Stephen DeFelice of the Foundation for Innovation in Medicine played a major role in the drafting of the bill, sources say.

A source close to Pallone’s office agrees that the approval process the bill proposes for nutraceuticals would be more stringent than the review process for dietary supplements, but says that as a result, a company could make stronger claims for nutraceuticals than for dietary supplements.

The source says the congressman has been interested in the issue of dietary supplements for some time and was involved in the original discussions on DSHEA.

Pallone has no co-sponsors as of yet, according to the source, who said the office has been busy with several other bills and has not had time to do the necessary outreach to obtain co-sponsors. But, the source predicted the office would have no trouble getting supporters and co-sponsors based on what it has heard from industry.

But several dietary supplement lawyers disagree. They say that the bill will have serious trouble getting passed, and contest that Pallone will easily find supporters. Although the bill is actually known as the “Nutraceutical Research and Education Act,” one prominent dietary supplement lawyer joked that the bill should be called, “the DeFelice Act.” The lawyer says that DeFelice has built his career on this issue. Another dietary supplement lawyer said the entire industry wrote off DeFelice’s concept a year ago. That source said that no one in the industry will really support it.

DeFelice does not deny the fact that he does not have companies behind him, in fact he relishes his independence. DeFelice is confident that the American people and the media will generate the support needed to pass the bill. He intends to hold a media event Feb. 3-4, 2000 in New York City to spark momentum.

One dietary supplement lawyer complained that the review process outlined in the bill would be just as difficult to file successfully, if not more difficult, than a new drug application. The lawyer says the dietary supplement industry will never have the data needed to satisfy the requirements described in the bill. According to the source, the dietary supplement industry is where the over-the-counter drug industry was 30 years ago; no one has done the clinical trials. When asked about the difficulty of conducting one clinical trial, the source said that the bill requires at least one clinical trial, and that there is discretion on the part of the advisory committee on how much is needed. The lawyer says that the bill is setting up a system of pre-market approval.

But DeFelice says that the lack of clinical trials is exactly the problem he is trying to address. Industry, says DeFelice, does not want to do the research or conduct the clinical trials. But DeFelice says research on nutraceuticals is inevitable, and needs incentives to get underway.

ne of the dietary supplement lawyers disagrees with DeFelice’s assertion that the industry does not want to do the clinical research. The lawyers says a lot of the big companies are already doing research as a way to distinguish themselves from the smaller companies, and that there is a natural evolution towards research.

But one dietary supplement lawyer says that the very incentive DeFelice is offering is a problem. The lawyer says that its not fair to take a well-known connection like the benefit of Vitamin C and preventing rickets, which people have known about for sixty years, do one study and then have a claim that no one else can use. Another lawyer says that such an example probably wouldn’t apply; that the bill is meant for new claims and original work.

Yet another lawyer is afraid of the effect the bill would have on DSHEA. Although the bill does not directly alter DSHEA, the bill would shift the regulatory structure used for regulating dietary supplements. Once the regulatory structure has been altered, it might lead to a re-opening of DSHEA, the lawyer worries. The lawyer says that there is nothing in the bill that is so important that it is worth the risk of re-opening DSHEA.

DeFelice responds that the dietary supplement industry thinks that DSHEA should not be touched because it wants to maintain the status quo. Nonetheless, he says that DSHEA is not going to disappear with the introduction of this bill.

One of the supplement industry lawyers says that the bill is a good start, but that it is too narrow. One of the fundamental problems with the bill, says the lawyer, is that in a case where three companies are already in the process of conducting clinical trials on a product, the company which runs out and files a petition fastest will be the one to get the exclusivity.

DeFelice says there should be a race between businesses. DeFelice also says that the lawyers are overlooking an economic advantage of the system. DeFelice explains that companies will be getting “a bigger piece of a smaller pie” and that a system of innovators and generics will be established just as it was in drugs. DeFelice says that industry has forgotten the importance of the patient.

One lawyer suggests that there are better ways of stimulating research such as a third-party review type program, where if a product met enough criteria it would be allowed to use a certain seal of approval. The lawyer also suggests that a monograph system might be appropriate.

One of the dietary supplement lawyers complains that the bill is poorly drafted and could encompass nearly all foods. For example, the lawyer says the definition of nutraceuticals covers foods, medicinal foods, or dietary supplements that are safe and have health benefits. The lawyer asserts that just about all foods have health benefits and are safe. The lawyer says the bill could potentially lead to all foods without approved nutraceutical claims being misbranded due to the bill’s poor drafting.

The bill would amend the misbranding section of current law by adding the following: “If it is a nutraceutical and it has not had a petition approved under section 403(r)(4)(D).”

It is unclear what FDA thinks of the bill. DeFelice says that he has had a courtesy meeting with FDA to let the agency know what he was thinking, but that FDA did not indicate what it thought of the proposal. Pallone’s office has yet to meet with FDA. DeFelice has invited FDA to his February meeting.

A source in Pallone’s office thinks FDA will like the bill because it gives the agency more authority over dietary supplements, but adds that given past experience with FDA, the agency is likely to complain that it does not have adequate funds to implement the proposed review process.

An FDA source complained that the bill’s definition of nutraceutical as having a benefit “which prevents or reduces the risk of a disease” would make the product a drug. The FDA source stresses that the definition of a drug revolves around the intent of the product, so if a broccoli producer sells broccoli as a treatment for cancer, it is a drug and not a food.

DeFelice says FDA is too focused on statutory definitions.