Might be of interest - Hatch, FDA

[Guest guest]

http://www.sltrib.com/sltrib/politics/52397201-90/companies-dietary-fda-

guidance.html.csp

By Matt Canham

The Salt Lake Tribune

First published Aug 16 2011 10:56AM

Updated Aug 16, 2011 10:09PM

Washington * The main players in Utah's dietary supplement industry will

meet privately with Sen. Orrin Hatch on Wednesday to voice their

concerns about a federal proposal they say may impede the sale of new

products and possibly ban some health aids altogether.

The gathering at Utah Valley University will involve the heads of five

national trade groups and focus on the Food and Drug Administration's

" new dietary ingredient " guidance, essentially a set of instructions

intended to clarify a murky federal law.

That landmark law, passed in 1994, said anything already sold as a

supplement is considered safe but companies rolling out any new

ingredients would have to submit to an FDA safety review. Even

government officials admit that it was unclear when such a review was

necessary, and consequently, many companies simply ignored the

requirement.

In 1994, the FDA estimated that 4,000 dietary supplements were on the

market. It now says there are more than 55,000 products, but in all

those years the agency has only received 700 new dietary-ingredient

filings.

While many of the new products are likely reformulations of previously

sold substances, such as multivitamins, a number are undoubtedly new

ingredients.

" I think most people in the industry would say we have been under-filing

in the last few years, " said Steve Mister, president of the Council for

Responsible Nutrition, one of the trade groups. " But it was because we

haven't had any clarity from the agency. "

Hence the draft guidance, a lengthy question-and-answer document meant

to make it much easier for companies to know when to file, what

scientific data to include and in what format.

The industry has until Oct. 3 to submit comments about the proposal, but

the trade groups have asked for an additional 45 days. When the comment

period ends, the agency will review the suggested changes before issuing

a final version some time in 2012.

Hatch, who wrote the 1994 supplement law, organized Wednesday's meeting

to discuss what the supplement companies should include in their

comments. The senator may file his own official comments, and if he does

so, they are not likely to be positive.

The United Natural Products Alliance, a Utah-based trade group, which

employs Hatch's former chief of staff Knight, held a meeting on

the guidance in July. Hatch couldn't be there, but he did send a video

message.

" All of us share the common goal of consumer safety, and the present

task is to do so as efficiently and in as market-friendly a way as

possible. I worry that this guidance misses that mark, " he said. " I am

particularly concerned about the economic impact that this policy will

have on your industry. "

Many supplement executives see the guidance as an overly proscriptive

time waster, while the FDA considers its draft instructions as " a

preventative control " that protects consumers.

The two sides are dredging up the decades-old fight over who has to

prove whether a natural product is safe: the government or the

manufacturer that sells the product. The 1994 law largely said the FDA

must prove a supplement is unsafe.

" What I see in this guidance document in a number of ways is FDA trying

to redistribute that balance of who has that burden of proof, " said

Mister. " And the industry is really unhappy about it. "

Fabricant, the director of FDA's Office of Dietary Supplement

Programs, bristles at the insinuation.

" We operate under the understanding that Congress does what they mean

and mean what they say, " Fabricant said. " The statute puts the

establishment of a reasonable expectation of safety of new dietary

ingredients on the manufacturers and distributors of dietary

supplements. That is pretty clear. "

Supplement companies fear the guidelines could force them to remove

thousands of products from the market while they submit to the safety

reviews, which could take as long as 75 days. They also fear that if FDA

gets hit with a rush of filings the process could drag on much longer,

putting the companies in the position where they either hold their

products until the review is complete or send them to stores hoping the

FDA doesn't issue a recall over a safety concern.

The FDA has never seized supplements because of a new dietary-ingredient

review, and Fabricant says the agency hasn't missed that 75-day mark

yet, but he did challenge the logic of the industry.

" That is kind of like me saying 'I'm not going to go to the DMV to get a

license because it takes three hours and I really want to go somewhere

in two hours,' " he said.

Among the more controversial guidelines, FDA believes supplement

companies should file if they change the chemical structure of a

substance in any way, say, if they use a new extraction method to get a

liquid from a plant. Also, the guidance document says it is illegal for

supplement companies to market botanical compounds synthetically

produced in a laboratory.

Mister argues that changing the processing method of an ingredient

already presumed safe shouldn't require a new dietary-ingredient report

and that there is nothing wrong with creating a supplement in the lab as

long as it is biologically identical to the real thing.

" The substance is the substance is the substance, " he said.

Fabricant says the FDA should check the safety of any substance that

hasn't been in the human diet before. " That is how the law reads, " he

said.

If these disputes remain unsettled and the FDA issues a final guidance

document that makes the industry recoil, Mister says it makes sense for

supplement manufacturers to turn to Congress and Hatch in particular.

" Who better to lead the charge to explain to FDA that they are

misinterpreting the law than one of the original authors of the law, "

said Mister. " If FDA does not back down from some of these positions

that we believe misinterpret the law, then Congress has the opportunity

to go back and amend the statute. "

Tyler Whitehead, the general counsel at Utah's Nu Skin, a large

supplement company, will attend Hatch's meeting, but he's trying not to

get too worked up over the draft guidance. He wants trade groups like

Mister's Counsel for Responsible Nutrition to continue its work in

providing detailed responses to the FDA's proposal, but he also knows it

is likely to change in considerable ways before it goes into effect.

He doubts the agency would use the guidance to make well-known companies

remove products from the shelf pending a safety review. He also thinks

the new instructions should have little financial impact, at least on

the big companies.

" But it is hard for us to predict how they will use this as an

enforcement tool, " he said.

He remembers a similar confrontation over manufacturing rules that

started with contention but ended with widespread agreement.

" It is a process, " he said. " And this is the beginning of the process,

not the end of it. "

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

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Office ext. 5109

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Email: dkalman@...

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