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FDA's enforcement deserves loud applause

A flurry of seizures, criminal charges, and warning letters shows that FDA is increasing it enforcement of dietary supplement regulations. Good for FDA and good for industry!

For too long, a light touch from FDA has allowed critics of the industry to claim dietary supplements are not regulated, and that the industry is like the Wild West.

The industry is regulated – it has its very own regulation (DSHEA) – and FDA deserves credit now for flexing its muscles. Most of the serious suppliers, companies and associations I have talked to are happy to see it.

We shouldn’t be surprised by this: FDA Commissioner Margaret Hamburg, MD, sent a letter to supplement manufacturers in December reminding them of their legal obligations and the need to remain vigilant to protect their industry.

This was followed by a warning to consumers in March to “beware of fraudulent dietary supplements” .

Case study

At the start of the month, the Department of Justice found two New Jersey based supplement companies and their owner guilty of multiple counts of criminal contempt of court for violating a consent decree .

The announcement was greeted by applause from a raft of trade associations, including the Council for Responsible Nutrition (CRN) the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA).

As CRN president Steve Mister told me in an interview last week, the recent events are reminding the industry that FDA has teeth.

Not everybody was happy though. We received one comment from a reader who criticized FDA:

“OK, we've got live rats running through the plant and dead rats too! But was anybody harmed? Did patients die or suffer health effects? Sanctioning a company is one thing, putting them out of business is another. Why would the industry applaud this? It's an FDA overkill (not the rats, the company),” read the feedback.

Really? So companies that flout basic sanitary guidelines should be allowed to continue to operate, albeit with sanctions, despite warnings from the authorities?

Nobody was harmed? “Yet!” I would like to add. With rodent feces and missing rodent parts floating around a facility, you could argue it was only a matter of time.

FDA was within its rights to do what it did, and I echo the applause from industry.

Claims

I also applaud the recent activity regarding claims being made on products: If you make disease claims, you’re a drug and you need to go through the channels for that. If you want to be a dietary supplement, then follow the rules laid out in the Federal Food, Drug, and Cosmetic Act.

Warning letters are issued for a reason – to warn – and nobody should act surprised or upset when tougher action follows.

Pats on the back

For the moment, many are happy to see the regulators regulate. Some are, as the feedback suggests, conscious of potential over-enforcement by the authorities. Let’s also not forget that action after action by FDA or FTC may also be interpreted by some that the industry is full of offenders, but responsible and serious players have nothing to fear from such enforcement.

Industry associations are also playing their part: Look to the Natural Products Foundation’s recent referral of 13 dietary supplement firms making unauthorized disease and drug claims about dietary supplements to FDA and FTC, and CRN’s funding of an attorney specifically to tackle false claims about dietary supplements at the National Advertising Division of the Council of Better Business Bureaus (NAD).

Showing how it’s done

It is also pleasing to see responsible companies reacting quickly to potential issues. Only this week, NOW Foods swiftly issued a voluntary recall when two supplement batches were found to contain way more vitamin D then they were supposed to.

After receiving only a couple of adverse event reports (AERs) related to the products, the company initiated in-house lab tests and quickly issued the recall. Credit to NOW Foods for its professional, responsible and swift handling of the situation.

Take home

After a busy few months, there appears to be no sign in the downturn of FDA/FTC activity. If everyone wants to play the game professionally, then they have to accept the decisions of the referees: The ref is there to ensure everyone plays by the same rules, and we should respect that.

Hopefully, recent activity is merely the storm before the calm.

17 comments (Comments are now closed)

Housecleaning within the FDA..

Ok, Stephen, let's go with your support of FDA "enforcement" in the supplement business. Can we also agree to a thorough housecleaning and COMPLETE audit of the agency to be included in this growing control mechanism?

With the absolute corruption taking place inside the agency, giving the FDA more teeth would be like giving Al Capone more guns and the authority to monitor the gambling business.

Let's get real about the corruption inside the system. Orrin Hatch resides in a state which is loaded with large supplement companies. Although they mostly put out good products, this smells like a protectionist move as much as quality assurance. The rats found in that company's facility are synonymous with the rats within the agency getting extra cheese on the side through politicians and lobbyists.

How can a dirty agency demand a clean supplement business? AUDIT the FDA, as well as ALL regulatory agencies, clean out THEIR rats, then start over with a clean house.

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Posted by banh
27 June 2011 | 18h44

Stephen Is Right

Many doctors, researchers, and politicians would like to ban most supplements. They would copy the European model whereby only a few supplements would be available in very small, ineffective doses. There is an entire reseach industry based on isolating components from naturally-occurring substances and marketing them as patented, high-priced drugs. These researchers detest dietary supplements. Then there are politicians who want to federalize all healthcare decisions (Obamacare is the beginning of this process). To them it is anathema that American consumers have the freedom to purchase and consume supplements.

From these powerful interests come the constant complaints of an "unregulated industry". 1994's DSHEA was a fantastic achievement - but its provisions must be enforced! This is the only way to forestall efforts to repeal DSHEA entirely. It also shoudn't be forgotten that product adulteration and the wildly exaggerated claims coming from some companies undermine public confidence in the entire industry. So I agree with Stephen Daniells - stronger FDA enforcement is necessary.

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Posted by Jeff
25 June 2011 | 17h56

As things stand, and glimpses of things to come

Hello everyone,

As one of the comments says, it does indeed seem that I hit a nerve with this piece. For years I have listened to many in industry talk about a light handed touch from FDA towards dietary supplements – indeed, I’m sure many have heard tales alleging that FDA folks in the past were instructed to not enforce DSHEA very strongly in order to create the impression in consumers’ minds that dietary supplements were unregulated.

That was then, and I would argue that the FDA of Margaret Hamburg is not the same beast. Indeed, Ms Hamburg has made very public statements, which I reference in the article above, that there would be increased enforcement of DSHEA and the GMP regulations.

This is what a lot of people wanted: When Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA) introduced the “Dietary Supplement Full Implementation and Enforcement Act of 2010” all of the main trade associations applauded.

Let’s not act surprised when we now see an increase in enforcement by FDA. We should also not be surprised when this is heralded as welcome – I am not the first to applaud the action, nor will I be the last.

I cannot stress enough that this comment is limited to the recent actions by FDA and the message it sends to other companies who may also be sitting on a warning letter and hoping FDA will not follow up. I am a long, long way from saying FDA is perfect.

In writing the article above I decided to raise my head above the parapets and make a bold statement in support of the recent activity. Many thanks to the brave few who registered their support of my statements.

For those who disagreed, I respect your right to comment, even though some seem to not respect mine. Many of the statements and concerns aired in these comments have been heard before and we must continue to ensure that respectable stakeholder concerns remain audible.

Within the comments below are also glimpses of what comes next: The question has been asked as to whether the pendulum of enforcement could swing/ is swinging too far in the other direction: There are statements alleging FDA has exercised/ is exercising an "overzealous interpretation of GMPs".

As the situation develops I will reassess my position, as should everyone, and I remain ready to change my opinion when presented with new facts, but, as of today, I stand fully behind my comment that recent activity was a good thing.

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Posted by Stephen Daniells, Senior Editor of NutraIngredients-USA
16 June 2011 | 20h51

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