One Last Poke in the Eye from FDA Acting Commissioner Sundlof
The Acting FDA Commissioner issued a statement concerning particularly the unfortunate situation with Hydroxycut products. Dr. Steven F. Sundlof (yes another Veterinarian running the FDA) made some very solid points in his presentation. Sadly he made some other points that are worth noting and should make us glad that perhaps the next commissioner (the one without the ACTING in front of the title) is soon to come into permanence. Still, as parting shots go, this one from the Acting Dr. Sundlof had its moments
Let’s review the Good News first. The Good News is the tone taken in the overall message. It is one of reassurance and one that should put the consumer’s mind at ease.
“FDA issued a public warning and the company recalled these products because some of the products were associated with a number of serious liver injuries.”
Read that excerpt carefully. FDA issued a warning – all that they could legally do within the confines of the law but they issued it promptly. It was the industry member (the manufacturer) who recalled the products – not FDA. FDA’s role in protecting the public health was minimal. The company performed the recall in an effort to demonstrate responsible action. There should not be rounds of applause for this without knowing what the manufacturer knew of the potential for harm its supplements were capable of.
“FDA received 23 reports of serious health problems . . .”
First of all the reason FDA received these reports is due in large measure to the Dietary Supplement industry prompting Congress to act and require the establishment of an Adverse Event Reporting System for all manufacturers of Dietary Supplements. Second. these reports obviously pointed at several Hydroxycut branded products. The “associated with” aspect of the initial quote is sketchy. What was the degree of association? Was there a direct link between consumption of the product and the adverse events? The actions thus far would indicate this since the manufacturer recalled the product without argument. The BIGGEST issue is whether the manufacturer had awareness of the problem in advance. This will likely be discovered going forward. This awareness or lack thereof regarding the products sold should raise an eyebrow or two above the eye just poked here from among those of us in the industry using the same ingredients or very similar combinations. Since multiple formulas were involved one must look to see what the common ingredients and combinations of ingredients were before we can firmly commit to what may have caused the adverse events. Then you should ask yourselves the question as to whether your products bear too much similarity to the products recalled. If so, what are you prepared to do about it?
Now let’s give a good poke in the eye to the outgoing Acting Commissioner as well. You see aside from taking credit where only some credit was due, Dr. Sundlof also took the opportunity to cast a little misrepresentation and disingenuousness at the Dietary Supplement Industry once more. Dr. Sundlof saw fit to remark:
“As a dietary supplement, Hydroxycut is regulated differently than either prescription or over the counter drugs, whether prescription or over-the-counter.” [sic]
This little bit of redundant presentation is accurate. However Hydroxycut and all other Dietary Supplements ARE regulated. Going on about the apparently lamentable situation Dr. Sundlof drifts into classic DSHEA bashing:
“Under the 1994 Dietary Supplement Health and Education Act, dietary supplement manufacturers do not need to register their products with the FDA nor obtain FDA approval before producing or selling dietary supplements.”
This is only a slight twisting of the truth. DSHEA did nothing to either remove registration requirements or to mention such registration. These products have NEVER been required to be registered. Still. Dr. Sundlof decided to point the finger (or should I say paw) of blame at DSHEA for this situation. DSHEA had nothing to do with the current and historic state of affairs. Dietary Supplements are a class of FOOD and thus not subject to registration, as are DRUGS as Dr. Sundlof implies. DSHEA did not create the situation, it is responsible for a lot of things that have gone awry within the industry but lack of registration of products is not one of them.
Dr. Sundlof is not finished though. One more bash before he returns to his hoof and horn practice:
“The FDA has taken other recent actions to help protect the safety of consumers of products marketed as dietary supplements. This March, the FDA issued a nationwide alert about more than 70 tainted weight loss products containing undeclared, active pharmaceutical ingredients - including prescription-only drugs.”
This again is a true statement. At least up to the point where the products are identified. The weight-loss products identified were not, by legal and regulatory definition, Dietary Supplements specifically because they contained “active pharmaceutical agents.” This renders these products DRUGS that are being marketed as Dietary Supplements. The challenge is less in the fact that Dietary Supplements are not regulated as drugs but more in the fact that Drugs are being included in and misrepresented as Dietary Supplements. The enforcement actions taken were applauded by the Dietary Supplement industry while not a whisper is heard from the pharmaceutical industry – perhaps because of the loss of business from these miscreants.
The last point of note from the good Dr. Sundlof is a slightly altered echo from the Dietary Supplement industry itself:
“ . . . FDA suggests that you consult with a health care professional before using any dietary supplement because many supplements contain ingredients that have strong biological effects . . .”
The Dietary Supplement industry as long advocated discussing with your health care provider your consumption of dietary supplements of all sorts. The challenges have been in the receptivity of the physicians owing to their lack of knowledge and the misinformation handed to them by, among others, FDA. The second part of this last statement is very interesting. FDA has historically denied any activity on the part of dietary ingredients and dietary supplements. They deny any benefit and thus, in risk/benefit analysis, which is the direction FDA wants to take the discussion, there being no benefit, ANY risk eliminates the dietary ingredient. While stopping short of saying that dietary ingredients and dietary supplements provide benefit, at least there is acknowledgement that there is “biological effect.” I’ll take that stance even if it is from an interim voice. Sadly, Dr. Sundlof is not finished with the topic as the sentence concludes:
“ . . . and such products may not be safe for all people.”
The evaluation of safety was presented in DSHEA itself, ironically the amendment to the Federal Food, Drug and Cosmetic Act that Dr. Sundlof has such issue with. Congress found:
“ . . .dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare . . .”
FDA has not acquiesced as yet to these findings in spite of their mandate to do so as an arm of the government, not as lawmakers. With the imminent retirement of Dr. Sundlof to some other level of the bureaucracy, perhaps a more reasoned voice will emerge. Perhaps as well our industry will recognize the importance of understanding the ingredients we use to the fullest extent possible and not perform as the pharmaceutical industry has and sweep the bad news under the rug and rely on FDA to act. We shall see.
Let’s review the Good News first. The Good News is the tone taken in the overall message. It is one of reassurance and one that should put the consumer’s mind at ease.
“FDA issued a public warning and the company recalled these products because some of the products were associated with a number of serious liver injuries.”
Read that excerpt carefully. FDA issued a warning – all that they could legally do within the confines of the law but they issued it promptly. It was the industry member (the manufacturer) who recalled the products – not FDA. FDA’s role in protecting the public health was minimal. The company performed the recall in an effort to demonstrate responsible action. There should not be rounds of applause for this without knowing what the manufacturer knew of the potential for harm its supplements were capable of.
“FDA received 23 reports of serious health problems . . .”
First of all the reason FDA received these reports is due in large measure to the Dietary Supplement industry prompting Congress to act and require the establishment of an Adverse Event Reporting System for all manufacturers of Dietary Supplements. Second. these reports obviously pointed at several Hydroxycut branded products. The “associated with” aspect of the initial quote is sketchy. What was the degree of association? Was there a direct link between consumption of the product and the adverse events? The actions thus far would indicate this since the manufacturer recalled the product without argument. The BIGGEST issue is whether the manufacturer had awareness of the problem in advance. This will likely be discovered going forward. This awareness or lack thereof regarding the products sold should raise an eyebrow or two above the eye just poked here from among those of us in the industry using the same ingredients or very similar combinations. Since multiple formulas were involved one must look to see what the common ingredients and combinations of ingredients were before we can firmly commit to what may have caused the adverse events. Then you should ask yourselves the question as to whether your products bear too much similarity to the products recalled. If so, what are you prepared to do about it?
Now let’s give a good poke in the eye to the outgoing Acting Commissioner as well. You see aside from taking credit where only some credit was due, Dr. Sundlof also took the opportunity to cast a little misrepresentation and disingenuousness at the Dietary Supplement Industry once more. Dr. Sundlof saw fit to remark:
“As a dietary supplement, Hydroxycut is regulated differently than either prescription or over the counter drugs, whether prescription or over-the-counter.” [sic]
This little bit of redundant presentation is accurate. However Hydroxycut and all other Dietary Supplements ARE regulated. Going on about the apparently lamentable situation Dr. Sundlof drifts into classic DSHEA bashing:
“Under the 1994 Dietary Supplement Health and Education Act, dietary supplement manufacturers do not need to register their products with the FDA nor obtain FDA approval before producing or selling dietary supplements.”
This is only a slight twisting of the truth. DSHEA did nothing to either remove registration requirements or to mention such registration. These products have NEVER been required to be registered. Still. Dr. Sundlof decided to point the finger (or should I say paw) of blame at DSHEA for this situation. DSHEA had nothing to do with the current and historic state of affairs. Dietary Supplements are a class of FOOD and thus not subject to registration, as are DRUGS as Dr. Sundlof implies. DSHEA did not create the situation, it is responsible for a lot of things that have gone awry within the industry but lack of registration of products is not one of them.
Dr. Sundlof is not finished though. One more bash before he returns to his hoof and horn practice:
“The FDA has taken other recent actions to help protect the safety of consumers of products marketed as dietary supplements. This March, the FDA issued a nationwide alert about more than 70 tainted weight loss products containing undeclared, active pharmaceutical ingredients - including prescription-only drugs.”
This again is a true statement. At least up to the point where the products are identified. The weight-loss products identified were not, by legal and regulatory definition, Dietary Supplements specifically because they contained “active pharmaceutical agents.” This renders these products DRUGS that are being marketed as Dietary Supplements. The challenge is less in the fact that Dietary Supplements are not regulated as drugs but more in the fact that Drugs are being included in and misrepresented as Dietary Supplements. The enforcement actions taken were applauded by the Dietary Supplement industry while not a whisper is heard from the pharmaceutical industry – perhaps because of the loss of business from these miscreants.
The last point of note from the good Dr. Sundlof is a slightly altered echo from the Dietary Supplement industry itself:
“ . . . FDA suggests that you consult with a health care professional before using any dietary supplement because many supplements contain ingredients that have strong biological effects . . .”
The Dietary Supplement industry as long advocated discussing with your health care provider your consumption of dietary supplements of all sorts. The challenges have been in the receptivity of the physicians owing to their lack of knowledge and the misinformation handed to them by, among others, FDA. The second part of this last statement is very interesting. FDA has historically denied any activity on the part of dietary ingredients and dietary supplements. They deny any benefit and thus, in risk/benefit analysis, which is the direction FDA wants to take the discussion, there being no benefit, ANY risk eliminates the dietary ingredient. While stopping short of saying that dietary ingredients and dietary supplements provide benefit, at least there is acknowledgement that there is “biological effect.” I’ll take that stance even if it is from an interim voice. Sadly, Dr. Sundlof is not finished with the topic as the sentence concludes:
“ . . . and such products may not be safe for all people.”
The evaluation of safety was presented in DSHEA itself, ironically the amendment to the Federal Food, Drug and Cosmetic Act that Dr. Sundlof has such issue with. Congress found:
“ . . .dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare . . .”
FDA has not acquiesced as yet to these findings in spite of their mandate to do so as an arm of the government, not as lawmakers. With the imminent retirement of Dr. Sundlof to some other level of the bureaucracy, perhaps a more reasoned voice will emerge. Perhaps as well our industry will recognize the importance of understanding the ingredients we use to the fullest extent possible and not perform as the pharmaceutical industry has and sweep the bad news under the rug and rely on FDA to act. We shall see.
Posted by Jim Lassiter at 5/19/2009 10:48 AM 
Categories: FDA and You, FDA Actions, Adverse Event Reporting
Tags: Law FDA Dietary Supplement
Categories: FDA and You, FDA Actions, Adverse Event Reporting
Tags: Law FDA Dietary Supplement
very informative details thanks for that, nice article
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