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FDA’s – and Obama’s – Broken Promises

“There are certain things that only a government can do. And one of those things is ensuring that the foods we eat …are safe and don’t cause us harm.”

                                                     President Barack Obama, March 14, 2009

Anyone who believes that the Food Safety Modernization Act protects this nation’s consumers from foodborne disease outbreaks is dreaming in Technicolor. And anyone who believes that the Federal Food, Drug and Cosmetics Act protects consumers from harmful drugs, cosmetics and medical devices is equally self-delusional.

Consider this:

Jensen Farms, the source of Listeria monocytogenes-contaminated cantaloupes that are responsible for 125 illnesses and 27 deaths, registered with FDA in 2011. FDA officials, speaking during a media teleconference last week, confirmed that the company’s operations had never been inspected by FDA, and that Jensen Farms was not scheduled for inspection until sometime between 2015 and 2017 – 5 to 7 years after registration – as specified under the Food Safety Modernization Act.

Larry Schultz Organic Farm, a free-range shell-egg producer that was linked last week to six cases of Salmonella Enteritidis infections in Minnesota, was not covered under FDA’s Egg Safety Rule, because the company maintains fewer than 3,000 laying hens. In contrast, the “small producer” definition in the United Kingdom is fewer than 350 laying hens. FDA has no plans to inspect shell egg producers that maintain fewer than 3,000 hens.

CooperVision, a contact lens manufacturer and distributor, initiated an international recall of certain of its contact lenses on August 19, 2011. Recall notices were posted on government web sites in Hong Kong, Australia, Spain and Italy. The company successfully resisted FDA’s “request” to issue a public recall notice in the USA for almost two months. The Voluntary Recall was announced on October 13, 2011 – only after the shares of CooperVision’s parent company tanked as a result of publicity generated by eFoodAlert and by MSNBC.com’s JoNel Aleccia.

Insight Pharmaceuticals issued a “stealth recall” of more than 34,000 bottles of Nostrilla Nasal Decongestant nasal spray on September 19, 2011. Although a few retailers of the OTC nasal spray posted recall notices, the company only went public with its recall on October 19, 2011, explaining that the product was contaminated with Burkholderia cepacia – a microbe that is capable of causing very serious infections in people with compromised immune systems or chronic lung conditions. Insight exposed its customers to an unnecessary risk for a full month before publicizing its recall. Where was FDA while this was taking place?

The so-called Food Safety Modernization Act – a last-minute “compromise” to salvage a worthwhile project that was being sandbagged by certain”Congresscritters” – has buried FDA and the food industry in a quagmire of mandates and regulatory red tape that threatens to choke off any real progress toward a safer food supply. The situation is no better in the drug, cosmetic and device divisions of FDA, where mandatory recall authority is so tied up in “process” that it is non-existent.

Our tax dollars are being frittered away by pissant politicians who believe it more important to make speeches about the repugnancy of their opponents’ ideas than to reach practical and effective bipartisan solutions to our pressing health and safety problems.

At this rate, we might as well disband FDA’s Food Safety operations and take our chances with the free market. The money we save can be used to defray the medical costs resulting from foodborne disease outbreaks.


“FDA’s – And Obama’s – Broken Promises’ was first posted by Phyllis Entis on her blog, eFoodAlert, on Oct. 22, 2011. Reposted with permission.

© Food Safety News
  • Gustaaaf van der Feltz

    The Hague, Netherlands, October 25th 2011
    Dear ,
    Re: An approved processing aid against Listeria
    On the internet I read that President Obama has said:There are certain things that only a government can do. And one of those things is ensuring that the foods we eat …are safe and don’t cause us harm.” Alas he forgot to say that there is a perfect remedy against Listeria contamination. It is approved by the FDA!
    I am writing to you because I am a former listeriosis patient. Luckily I had a strong enough immune system so I did not die, but I was very, very sick!
    I gather you do not know of the product called LISTEX P100. Listex is a safe (FDA approved as GRAS = Generally Recognised as Safe) phage preparation produced by the Dutch company Micreos Food Safety in Wageningen. (See link: http://www.infectioncontroltoday.com/news/2011/05/usda-approves-listex-as-processing-aid-against-listeria.aspx . ) It is also approved as a processing aid by Health Canada and in many other countries. It is a natural and relatively inexpensive product, much cheaper than destructing a great lot of good product or having to worry night and day about possible product contaminations with Listeria or the bad reputation you can get in your business. A great amount of advertising money down the drain! Above that a lot of investing to save your revenue!
    Micreos’ website is: http://www.micreosfoodsafety.com . In my view it is worthwhile to contact them. They are working worldwide. On the site you will see how it works. The product can also be used on all organic products (OMRI listed), it is effective against only Listeria (leaving even the ‘good’ bacteria in place), and has no effect on any other food properties (color, odor, texture, taste).
    It could also be valuable for a company to use Listex, because it is an approved and effective measure against Listeria monocytogenes and every food producer can use it. Because of the high risk associated with Listeria, if the company does not take measures against it, they could expose themself to liability. Sadly, more than 400 deaths in the US and Canada underscore this!
    Listex is very well known in the food business, it was honoured with the gold award of the Food Ingredients Europe.
    Contacting http://www.Micreos.com can mean the salvage of a company. And also can save many deaths and illnesses like mine!
    To be precise: I am not on the pay list of Micreos Food Safety, I am just working to ban the Listeria bacteria. I do not want other people to suffer from listeriose like I did.
    Perhaps you could write an article about Listex. You can find it on the Internet and Micreos can supply you with all the details you want.
    May I ask you your opinion on how to ban Listeriose on my e-mail g.van.der.feltz@ziggo.nl
    Thank you in advance!
    Gustaaf van der Feltz ( g.van.der.feltz@ziggo.nl )

  • Paul

    This is a little harsh. There may be a few thresholds that could be boosted, as with the eggs, and the Act could be stronger, but it will, even if by degrees, improve food safety. Of that there is no doubt.