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Credit where credit is due: FDA activity is a good thing
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
FDA hired henchmen for pharmaceutical industry
The potential for serious harm from FDA "approved" pharmaceutical drugs is much larger than that from natural products; yet the FDA continues to focus on harrassment of dietary supplement producers. Powerful, well-funded lobbyist; revolving doors (FDA regulators moving "up" to pharmaceutical industry jobs and extreme pressure for positive results from drug trials have perverted the FDA.
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Posted by Steve Farrar
16 June 2011 | 19h56
Where's the other half of the story?
Based on the comments here, the author struck a nerve. Yes, it's laudable to go after the rat-infested companies that are not in compliance with good manufacturing practices. However, what about the companies that are making a good-faith effort to comply and even acted proactively earned NPA's GMP rating? The FDA is issuing Warning Letters to many of these same companies due to overzealous interpretation of GMPs. They have gone beyond the original intent of DSHEA. The author seemed to miss this point.
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Posted by MDR
14 June 2011 | 22h24
FDA raids are good?
I am sorry, if a company responds to FDA letters and takes down wording or label info and gets ride of product it is not necessary to bring in armed people (SWAT teams)to stop the company. That is overkill!
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Posted by Mickey
14 June 2011 | 16h54
Congressman Ron Paul is introducing legislation to require the FDA to prove inaccuracy in any company's product claims before taking action against the company for its claims.
Congressman Ron Paul is introducing legislation to require the FDA to prove inaccuracy in any company's product claims before taking action against the company for its claims.
comment: Thanks for the info Lyndon ! ! !
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Posted by ANNE
14 June 2011 | 12h25
FDA holds up Elderberry Co.
FDA held up an Elderberry Co. "at gunpoint
for making false claims; comment: NO OTHER GOV. AGENCY HOLDS CO. UP AT GUNPOINT
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Posted by ANNE
14 June 2011 | 12h20
Excellent Perspective
Steve, I applaud the courage and the perspective of your article. For too long,
the functional food and the natural medicine industries have been looked upon
like the "snake oil" industry of the bygone era propagated by claims of irresponsible and unethical companies multilevel and otherwise. Obviously "self regulation" is not enough. Reputable companies should take the lead to bring transparency, legitamacy, and respect to industry.
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Posted by James Thai
14 June 2011 | 02h39
Astonishing
I found this article to be incredibly superficial and almost childish in its implicit ignorance of the history of an agency that has been singularly hostile and malicious in its actions and policies towards our industry. Coming from a journalist who one assumes writes from a position of expertise and authoritative knowledge it is a travesty. I suggest that Mr Daniels do at least a modicum of research on the public record of FDA corruption, intimidation, incompetence, and mendacity before heaping praise on this agency. The snippet about NOW implies that the rest of the industry would ignore a serious dosage issue with one of their products. Mentioning this matter is a pointless waste of editorial space and an insult to all of us.
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Posted by Debora Bialack
14 June 2011 | 00h26
Can't believ you are serious
It is obvious you are a journalist and not actually making your living in the supplement industry. If you applaud the FDA's terrorist tactics in putting families out of work and on the street who were previously employed in the Health Supplement industry, but were put out of business because the refused to knuckle under to the pharma controlled regulators, and to which there is no appeal, you are either bought off or seriously mislead. What about looking at simple health statistics, like the fact that the USA has the lowest remission rates of any country in the world for cancer? Why do you think that is, because our medical system and the paid for regulators are the best there is? Or could it be because our medical system is bought and paid for by the highest bidders with no options and no appeals? It is too bad a previously good industry journal is now turned to garbage with this kind of "reporting". Don't bother sending me any more issues, I am not interested in reading any more of this crap.
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Posted by John Bear
13 June 2011 | 20h49
What's the main objective of the FDA??
Why does the FDA exist? Isn't it to safeguard the public against harmful foods and drugs? SO, why have there been hundreds of FDA-APPROVED drugs involved in class action lawsuits after killing or permanently effecting consumers? Can we compare this please to the number of supplement-related deaths?? Anybody got statistics on that?
Now we need to talk about the lobbying done (commonly called BRIBES outside the USA) by large corporations to safeguard their PROFITS...not public safety, but the health of stock holders in these multinational companies who still buy questionable resources from places like China. China is involved in at least one tainting or contamination scandal monthly. These drug companies which manhandle the supplement industry through the FDA and through bribery.. sorry, LOBBY dollars in DC. are attempting to eliminate the industry or put it under their oversight and control. Look what's happening in the UK for example.
There is an ill wind in America right now. It smells bad, and it smells like corruption. It's coming from Washington DC and all those "handlers" we've elected to manage our lives. There's an election coming in 2012 which will be a turning point for this country. CORRUPTION will be eliminated, and guys like RON PAUL will show us how to do it. Anyone working in DC "regulating" the public had better find their old business cards and dust off the old "shingle". The lobby industry and the back door access it gives to consumers' pockets in the name of "safety" will be evaporating soon. Anyone who lives in blind faith of this scam needs to wake the hell up or get an EU passport... the "serfdom" is over there.
The FDA is as corrupt as Berlusconi's "ethics committee" in Italy.. if he had one. I have a question... is Nutraingredients a non-profit, and who's cutting the support checks?? I smell something..
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Posted by Banh
13 June 2011 | 20h01
What happened to free speech?
"If you make disease claims, you're a drug, and you need to go through the channels for that." Are you serious? How can any substance, scientifically, be a "drug" if one company sells it and "not a drug" is someone else sells it -- or not a drug on Monday and then a drug on Tuesday and not again on Wednesday -- depending on what is SAID about it?
And what is a "disease claim"? If you take the "cure, prevent, mitigate" premise literally, then anything you consume in order to have a positive effect on your health becomes a "drug", including everything in a capsule, since virtually no one takes capsules of anything just for the fun of taking capsules. Either we're implying, or the customers are inferring, some "anti-disease" factors in virtually everything we make and sell.
Space doesn't permit detailed examples of the FDA's heavy-handed attacks, even on companies who scientifically BACK UP their claims. If REAL drugs are regulated differently than supplements, it's because they're inherently more dangerous, NOT because they fight disease and our industry's products don't.
For the FDA to obscure this simple fact in going after supplement manufacturers even for legitimate claims is as dishonest as it is oppressive. For a supposedly pro-industry writer or organization to give the FDA unqualified support in this is outrageous.
Congressman Ron Paul is introducing legislation to require the FDA to prove inaccuracy in any company's product claims before taking action against the company for its claims. False claims, like rat droppings, are fair game for FDA enforcement. But let's not roll over for Big Pharma on basic American freedoms.
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Posted by Lyndon Olson
13 June 2011 | 19h28
Pandering to the FDA
Anyone who believes that the FDA can be trusted to act in an ethical unbiased and entirely legal manner is naive. One simply has to review the history of malicious actions taken by that agency to see that this is simply not the case. The fact that the honest and reputable companies support fair and even enforcement of the DSHEA need not even be stated. This is not the issue here. Of course we do. The question is to what extent is the FDA is doing the bidding of the pharmas vs upholding their mandate to regulate the supplement industry. I, for one, am not nearly as sanguine about this question as the author obviously seems to be.
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Posted by Antonio vecchiarelli
13 June 2011 | 19h09
look out
the FDA is just flexing their muscle on the easiest of cases, setting precedent and procedure to then go after everyone else.
"first they go after the S.O.B.'s and then they will come after you and me".
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Posted by mrbevergae
13 June 2011 | 18h53
I agree completely
Excellent article, Steve. As someone who has been in this industry for over 20 years and worked to distance the responsible core of the industry from companies who make us all look bad, I'm very happy to see FDA at long last enforcing DSHEA. Calls to regulate dietary supplements like drugs are fueled by illegal behavior, and it takes industry and regulatory agencies working together to protect our long-term viability. And, seriously, who wants to take a product made in rat infested surroundings? That's just disgusting, and there is no possible excuse for it. Whoever sent that comment should go work in another industry because they are part of the problem.
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Posted by Suzanne Shelton
13 June 2011 | 18h43
Two sides to this sword
I agree that the industry benefits from rational and consistent regulation however there are aspects of the FDA policy regarding claims that constitute an unwarranted restriction on free speech. One such policy is to prohibit companies from posting the URLs of clinical trials which were undertaken by acknowledged authorities, in responsible well designed and peer reviewed published studies on the company site. Such citations are considered to be claims when no actual claim is being made by the company. Furthermore, the author seems to be infatuated with the FDA. There are clearly areas in which this agency has acted illegally to the severe detriment of supplement companies and there are certainly flaws that should be pointed out. To see an article which appears to be written by the agency's Public Relations department is a bit disconcerting, to say the least.
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Posted by William Shaw
13 June 2011 | 18h40
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