FDA Wants $220M from Food Producers After Congress Already Said No

March 27, 2012
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fda_logoCan’t get what you want by legitimate means? Just try an end-run around the system!

The FDA has submitted its budget funding request for FY 2013. That request includes $220 million in food facility registration fees. FDA would use the money to “increase its capacity to establish an integrated national food safety system and further strengthen food safety inspection.”

What’s a food facility? Unfortunately, it may include a family farm or a Mom-and-Pop food stand. As it stands now, it’s anybody the FDA thinks is involved with food.

This facility registration user fee provision was in the original version of the Food Safety Modernization Act (FSMA). But that, after intense criticism from us and others, was struck from the final version that was signed into law in 2011. What this new budgetary request means is that FDA is trying to circumvent the law—and the clear intent of Congress, just as they did with the NDI guidance document.

Food fees can drive small producers out of business. That might make life easier for the FDA. Like other federal agencies, they may find it easier  to work with a small number of giant companies. But with or without the fees, food facility inspections can also be a big deal.

The original version of the Food Safety bill mandated that every registered facility must be inspected by the FDA. We and others were able to exempt small farms with less than $500,000 in sales from these new federal inspection requirements—so long as the majority of sales are direct to consumers, restaurants, or grocery stores and those restaurants and stores are in the same state or within 275 miles of the farm. However, many small and organic farms make just a little over $500,000 per year or do not meet all these specifications, so they are not  exempt.

Under the law, as passed, high-risk facilities will be inspected initially within the first five years and then every three years thereafter; low-risk facilities, initially within seven years, and then every five. The FDA would need to hire an additional 5,000 employees to do all the inspections. Big companies love this, because the FDA would be so bogged down inspecting all the smaller operations that they wouldn’t have time to focus on the big guys—where the actual food safety problems arise. Food safety legislation should be targeted at the large industrial farms, but, no surprise, the bill as passed did just the opposite.

Inspections are also an opportunity for FDA to go on fishing expeditions when they want to target a particular company or industry—they can be as finicky as they wish, citing harmless paperwork violations as huge offenses, for example.

While FDA has not said what specifically they would do with the $220 million in new registration fees they are trying to sneak into the federal budget, it is clear that they are trying to restore what was denied them by Congress in  the final version of the Food Safety bill.

The agency has also implemented interim rules for administrative detention—rules that give FDA wider authority to detain foods, including supplements. This means that if FDA even suspects that a violation has occurred, they can detain a food or supplement company’s full stock for up to twenty days (with a possible ten-day extension if FDA wishes to initiate legal action), which might be enough to destroy smaller companies.

Why does this matter? Just ask the cherry growers, who were almost driven out of business for citing peer-reviewed scientific research about the anti-inflammatory properties of cherries!

This can now happen even where FDA only thinks a violation has occurred. Let’s say FDA finds third-party praise for a supplement’s therapeutic properties on a website related or linked to from the supplement company. Even though it’s a gray area, FDA may decide to pull a company’s products and make them battle in the courts for a decision on whether a third-party testimonial is a health claim attributable to the company.

After a bill is passed into law, it usually goes through a rulemaking phase, where an agency will flesh out how all the specific provisions in the bill will be implemented. That’s where the FSMA is now—the process of writing all the rules for the Food Safety Act is still in process. FDA delivered four proposed rules to the White House’s Office of Management and Budget (OMB) toward the end of 2011, but the rules have been “stuck in review” at OMB since then.

The Consumer Federation of America (CFA), a coalition of 300 nonprofit consumer organizations, has urged FDA to make public the proposed rules dealing with preventative controls for food, animal feed, produce safety and food imports.

FDA has invited comment from the public on many of the topics covered by the FSMA, but the agency has yet to submit those four proposed rules for public comment. We will keep a close watch on the proposed rules, and as we promised to keep you updated on the process, will let you know as soon as they are released and open for comments.

One of the things mandated by the FSMA was guidance on New Dietary Ingredients. As you know, their guidance document was a disaster, and ANH-USA has asked them to withdraw the guidance altogether and start over—as have a number of senators and congressional representatives.

Regular readers will recall our serious concerns with the FSMA. And then there was the controversial way the bill was passed in the first place—the bill was dead until the Senate resurrected it as an amendment to a completely unrelated bill. You can see the full timeline of FSMA-related battles here.

18 Responses to “FDA Wants $220M from Food Producers After Congress Already Said No”

  1. wvhillbilly says:

    it’s high time to clean out both the FDA and the USDA. Both are stacked with lobbyists and former officers of major drug and agribusiness corporations that have absolutely no business being on any government agency. Strict rules should be passed and consistently enforced by congress prohibiting anyone having any interest whatever in the corporations or companies they will be regulating from having any part in these agencies. Allowing lobbyists and ex-officials of such corporations to have a place in such agencies is a blatant conflict of interest and would never be allowed in private businesses, so why should it be tolerated as business as usual in government agencies?

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  2. Joyce Gilbert says:

    The FDA has to much power! How many dangerous drugs have they taken off the market ? too many people are dying from these drugs and their side affects. The FDA should be dealing with these companies and put them out of business. As far as supplements go? this is up to each person to check the ingredients and make sure they are taking the correct amount and they are ordering from companies that have been in business for years.

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  3. Michael Young says:

    The FDA is the most corrupt government department . They need to be relieved of all duties and totally reorganized. Big Pharma has all of the FDA personnel in their in their pockets and can get anything they want done whether it is approving a marginal or ineffective killer drug or stopping the use of natural proven remedies. Cherries comes to mind as a great anti inflamitory but producers are not allowed to say so.
    .

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  4. John Matheson says:

    I believe the death penalty would be appropriate for the corporate whores in the FDA.

       1 likes

  5. buck says:

    The ONE thing the FDA has not done the last twenty or so years is protect the American consumer from the big agribusiness , big chem , and other deep pocketted corporations . Meanwhile they harrase and intimidate the little mom and pop operations to make themselves look good . The raw milk episode and the multi-rabbit joke are perfect examples , not to mention the organic food store busts . Every department in the US government has become corrupt criminal organizations that need to be eliminated and recostituted with a whole set of new controls controlling THEM and all new people with honesty and integrity . Of course those requirements would eliminate all demonrats from applying .

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  6. Jenifer Parker says:

    So, what happens now?, does Congress slap the FDA on the wrist or do we roll over and take it?

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  7. Barb Gilligan says:

    Maybe we first need to define what is whole food and what does pure and natural mean, before we start putting fines and fees on business’. Soil testing on farms, food testing on large corporate claims. A definitive panel who has no cnnections with government, not appointed by the government, and who cannot accept bribes for decision making, overseeing FDA’s decision making. Decisions should be made on future outcomes of this planet, the enviroment, health and disease, we should be teaching people in 3rd world countries to feed themselves, that is the only lasting way, not selling them BIO engineered seeds. We need to get back to the basics. All BIO seeds should be distroyed, or there will be no future. FDA makes alot of noise to deter the people as to what really goes on, they seem to be accountable to no one. That needs to change, we as a nation need to stand up……they work for us, and are suppose to protect, they have failed, it is time to dismantle their empire. It no longer works.

       1 likes

  8. Grace Adams says:

    Food the FDA should leave to the USDA. Drugs the FDA already believes its mission is to protect the turf of the too big to fail drug manufacturers, so I wish the FDA could just be abolished–

       0 likes

  9. Barbara Mrozek says:

    It never ceases to amaze me how the FDA is controlled by the big boys. And also how these manipulators must sit up nights thinking how to continue with their bad habits by making trouble for others as a distraction from their greedy, devious ways. What I am thinking about just now are the filthy, cruel conditions under which our meat and some food is produced. The FDA would not need all these unnecessary inspections and regulations if the these big food industries would just clean up their ways. They do not want to do the right and decent thing – produce a healthy, clean, and nutritious food product by cleaning up their production methods. Yes, the bottom line will not be as big – but is that worth all the destruction they do to people’s health, land, water, animals, etc.? They really do not care and have absolutely no conscience or feeling about what it means to live and work in a decent society. And they apparently do not care about their own or their family’s health.

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  10. This makes me think of all the small organic farms in Vermont where my family lives.
    These farms sell items like small batch goat cheese an fresh vegetables to local restaurants and individuals. These farmers care so much about the land and the food they produce. It’s a beautiful thing. This must be allowed to continue and not stopped by some bureaucrat.
    The big industrial farms only care about profit. Yet the are allowed to run rampant over the population by the US government.

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  11. The FDA has and is overstepping what it was set up to do. It cann’t regulate it’s own duties, so keep the FDA’s hands out of our pockets and regulate what it was designed to do. They have already messed up our food supply.

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  12. It’s painfully clear that Big Pharma is back of all this. They want to cartelize vitamins, herbs, minerals & supplements so they can suck people dry of their finances by jacking up prices 800% and making these available only by Rx. They are heavy contributors to Senators and Congressmen whose conscience is always for sale. Their influence is pervasive at medical schools and in medical associations. I used horse chestnut & butcher’s broom to heal an aneurysm in my right subclavian artery. These vasoconstrictive substances worked magnificently. I used the citric acid content of fresh lemons to dissolve the arterial calcium I was also afflicted with. It worked far better than any vascular surgical procedure and left me without scars. I avoided damage to teeth enamel from the corrosive citric acid by immediately rinsing 6x with plain water. I stayed on the treatment for 170 days twice daily, but after 19 days, I felt normal. After 60 days I resumed heavy exercise without symptoms as a consequence. Big Pharma would have blocked me from using these simple, cheap modalities–which far outperform all of their noxious preparations–had it been able to do so. I have a $10,000 reward for any authenticated roster of The Pilgrims Society of the United States dating year 2000 or more recent, to be co-authenticated by Joel Van Der Reijden of the Institute for the Study of Globalization. This is the world’s premier financial organization. I guarantee it to feature chairmen and directors of the largest and most profitable pharmaceutical corporations.

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  13. Frank Apostol says:

    The only really effective way to deal with the FDA is to disband it and start over; as well should be done with Congress.
    We all know that the leadership of the FDA, as has the majority of congress, prostituted the powers of their positions to the highest bidders—and I don’t believe that the bids have to be too high.
    Our grocery store shelves are loaded with toxin containing foods, the toxins of which are proven. If the FDA was really doing its job, these toxins would have long since disappeared from our foods.
    Aspertame, high fructose cornsyrup, hydrogenated fat, the plastic used to line the interior of food containing cans, and several others, the names of which I cannot think of at the moment.
    Our government in general has decended to the level of a cruel and disgusting joke.

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  14. Patricia Kersten says:

    What is this even a controversy — the bill was dead until Senate decided to resurrect it and start working against on our supplements. Leave it alone!

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  15. Marjorie Tursak says:

    The FDA is loaded with drug company cronies. What can we expect? If we aren’t sick, they can’t sell us their pills, etc.

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  16. JOHN LONGENECKER says:

    Hello. As I see it the FDA is a great idea. All the ridiculous FDA stuff you report is prompted by BIG Corporations and their lobbyists. Food safety is wonderful. BIg Food, Big Milk, Big Meat, Big Vegetables, Big Snacks get the FDA to after whatever is small and good. The bad guys are Big Bad Guys, not food safety. JOHNLONGENECKER

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  17. Rix says:

    Boy I hope you can get a petition or direct line contact for usI have listed a couple of other petition sites on my facebook pages Rix Mohay Kline and Fracking Mad. With enough voices maybe we can all work together and keep the FDA honest. Get involved and blees you all.

       0 likes

  18. Robb says:

    Do you have a petition or action item we can work on?

       0 likes

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