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Cheryl Hadden got really ticked off when she read about the New FDA Strategy for Enforcement.  This post is her response.

Word Play at the FDA, Point-Counterpoint on Food Safety

by Guest Blogger, Cheryl Hadden

The incoming leadership of the FDA seems to be waging a war of words with itself. Or maybe they are trying to snow us with a blizzard of words so we’ll believe something is actually being done? All the bluster they can muster is just a little smoke and no mirrors.

When we get finished reading all the convoluted business-speak, what we are left with is a lot of hot air and no actual change or progress. But with all the big and pretty words they try to swamp us with, we aren’t supposed to understand that what they are saying a whole lot of nothing.

Another case of top officials trying to play the people for stupid, patting us on the head like children, and hoping we’ll never question them or hold them accountable for what they’ve said. Some of what they did say I decided to break down and read between the lines.

They said they wanted: “A strong FDA.”

That couldn’t be their goal, not if we take what they say at face value. What a recent missive outlined is really just more business as usual at the FDA, with a little added paperwork.

Of course, it can be counted on to harass and try to subjugate any kind of healthy, holistic, alternative food or supplement type of business, because the last director gave orders to ignore the DSHEA law.

The FDA has been running amok for the last 10 years, with the blessing of the previous director. I guess that is why he was replaced.

The FDA went so far as to a try to blackmail the Wilderness Foods of Minnesota into paying the FDA for the inspections they are demanding to do on a regular basis! Yes, the FDA is demanding to be paid $300 per inspection plus an hourly fee for the inspector!

There was no mention of rectifying that.

But the FDA can’t issue a statement notifying the public of a food danger before people get sick or die. However this is an issue for another day, another blog.

The new leadership of the FDA is advocating a bunch of nothing but fancy wording for continuing to do nothing different than is being done right now,  it just will sound impressive, important and very busy.

Long story short, we can expect the FDA to “fire off” a faster letter to violators and a promise not to wait as long as before “firing off” that second letter threatening action if the violators don’t comply in a little while. Maybe that’ll work, if the violators are afraid of memos and snail mail, a little threatening.

Oh, and a hint that the FDA might get nasty and give them a fine, maybe, probably. End of action.

This is progress?

Not in my book, not by a long shot. This is just simply not an acceptable policy change.

Here are the new FDA strategies (Point:), followed by my comments (Counterpoint:).

It breaks down like this, and you tell me if you see any improvements that we were promised.

This is the opening statement of an FDA letter:

Point: “To achieve more effective enforcement”, she said, ” the FDA must be more vigilant in following up on reported issues and in conducting regular inspections so that problems may be identified and resolved in their early stages.”

Counter Point: What does this mean? Aren’t they already supposed to be vigilant?  Or do they also feel like they are missing the boat on problems? Is it that they take so long to admit there is a problem that things get way out of hand before they take action to contain an outbreak or pull a bad product?

Point: “Additionally, FDA’s responses to violators must be strategic.” (This was all that was said about that)

Counter Point: What does that mean, exactly? How will this serve to deter future violations?
Why don’t they just shut down the violators, show them they mean business, and there won’t be any future violations. They are threatening them with the use of vague “meaningful penalties”, but never name the penalties.

Point: “FDA’s responses must also be made visible by publicizing enforcement actions,  as well as the rationale behind them, to industry and consumers.”

Counter Point: The only purpose is to scare the common people and make us fear the FDA. So far the only rationale offered is that they don’t really give a darn as long as the violator can pay up.

Point: “Finally, FDA must be able to respond more quickly when the public health is at risk.”

Counter Point: Faster than waiting until after several hundred people been sickened as with the peanuts, or 51,000 people have died as in Vioxx, before issuing a statement that there is a problem?

Having stated these general elements of effective enforcement, the letter then outlined six specific initial policy and procedural changes FDA will take toward that goal:

1. Post-Inspection Response Deadline: Effective Sept. 15, 2009, there will be an established time frame for the submission and agency review of responses to inspectional observations listed in a form FDA 483. Formerly, FDA’s receipt and review of such responses has tended to delay the issuance of a warning letter. Going forward, however, FDA will not delay the issuance of a warning letter in order to review a post-inspectional response that was received more than 15 business days after the issuance of the FDA 483.

Counter Point: This is classic doublespeak, sounds good, means nothing is changing.

[Note from Kimberly: inspectional is flagged by my spellchecker as a non word, so characteristic of bureaucratic goobledegook!]

Didn’t they do follow ups anyway? Are they saying that they will begin doing what they should have done in the first place?

2. An Accelerated Warning Letter Process: The process by which FDA issues warning letters will be streamlined, and thereby accelerated, by a new policy that will limit the Office of Chief Counsel’s review of warning letters to those presenting “significant legal issues.” Industry should expect a significant increase in the number of warning letters issued by FDA as a result of this new policy.

Counter Point: They’ve got me shaking in my shoes already. They really know how to put the fear of God in evildoers. First a warning letter and then threats of “an increase of warning letters”.

3. Coordination with Other Regulatory Entities: FDA will work more closely with its “regulatory partners” at the local, state, and international levels, which, in many cases, have the authority to act more quickly or with greater enforcement power than FDA in response to certain public health risks, such as food safety issues. Communication and coordination with other regulatory entities will allow for a rapid regulatory response.

Counter Point: Do they know what other agencies they will be working with? Are they saying that other agencies have greater power and control than the FDA does?

4. Systematic Follow-up after Enforcement Actions: FDA will promptly follow up on warning letters, enforcement actions and product recalls, to assess the corrective actions taken by non compliant firms. Such follow-up actions may include inspections and investigations. Too often in the past, FDA has either failed to follow up or allowed matters to linger for long periods of time as companies engaged in prolonged negotiations with the agency.

Counter Point: Isn’t that what they were supposed to be doing in the first place, or are they admitting that they had been doing a pretty lousy job all along?

5. Immediate Action in Response to Significant Risks: FDA will be prepared to take immediate enforcement action—even before the issuance of a formal warning letter—in the face of significant public health concerns and violations. In such situations, enforcement actions will no longer be preceded by multiple warning letters. As an example of this new policy in practice, consider the immediate action taken by FDA in response to reports that Zicam intranasal zinc products may cause a temporary loss of sense of smell.

Counter Point: But nobody died, the danger was minimal, temporary, and circumstantial. However, the target company’s entire business was making holistic health products.

The FDA issued a warning letter to Zicam, but rather than wait for a response before taking action, FDA also issued a Public Health Advisory the same day, warning the public not to use these products.

But in the case of the tainted hamburger, spinach and peanut butter, it took them weeks to even admit there was a contamination problem, no less do something about it.

By then people had started dying.

Why do they wait till there is death to take action?

6. A Formal Warning Letter “Close-Out” Process: In the event that FDA determines a formerly non compliant firm has fully addressed all violations non-compliant warning letter, FDA will issue a “close-out” notice to that firm. Such notices will be placed on the public record and posted on FDA’s Web site. The availability of this public close-out status is expected to motivate prompt corrective action and provide a major incentive for companies to complete the process as quickly as possible.

Counter Point: And this would achieve this how, what incentive do you see? And all this makes a better FDA in what way?

And so all in all what has been said that has value or meaning to the people?

Nothing, not a thing will help or protect the people, at all.

The FDA is a sham agency, they are worse than useless, they are deadly.

The FDA has police powers, but only uses these against the competition to the their own pet companies, the same companies that they don’t fine, don’t stop from violating, and freely do whatever they want with impunity and no fear of the FDA.

The FDA does less than nothing to protect the people, even with implementation of this plan.

So, twice nothing is still nothing!

Cheryl Hadden resides in Michigan. She’s a retired nurse, paralegal and real estate agent and alumni of Americorp-VISTA. Today she is a computer specialist, art teacher and potter. See Cheryl’s recent blog post on the Michael Schmidt case, Sleepless Over Michael Schmidt.

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