Ingredient Identity Testing
We’re from the FDA and We Want to Make Things Easier for You.
The FDA just published an inquiry in the Federal Register to the makers of Dietary Supplements ostensibly to determine if the submission of so-called “structure/function” claims to FDA is a burden. Please make no mistake: It’s a trick question
...<< MORE >>
...<< MORE >>
You Know Something's Happening, But You Don't Know What It Is . . .
While the industry is approaching the preparation for enforcement of the Dietary Supplement GMPs with its usual 11th hour strategy of action just before the hammer falls – another happenstance has surfaced. This one could have some significance and could be the death knell for a portion of DSHEA if not the whole of it. ...<< MORE >>
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.
Suppliers and Ingredient Identity Testing
There are some very good reasons behind the importance of Ingredient Identity. Most of these are obvious. However, there are a couple of reasons that are less obvious and that are rooted deep in the implementation of Dietary Supplement GMPs. These reasons fall to both the purchaser of the ingredient and a little more surprisingly to the supplier of the ingredient. Looking at it from both perspectives the reasons are very clear.
For the purchaser of the ingredient, the Dietary Supplement GMPs are very clear. The Final Rule requires manufacturers of Dietary Supplements to establish specifications for “identity, purity, strength and composition” of the ingredients used (empohasis added). You as a manufacturer as required to do this. The supplier of the ingredient is not so required. Recall that in the transition from Proposed Rule to Final Rule the onus of regulations fell off of the manufacturers of dietary ingredients and shifted exclusively to the manufacturers of Dietary Supplements. Also, the Final Rule also allows for the use of a Certificate of Analysis for assuring the identity of components. But you must read the fine print.
As a manufacturer of a Dietary Supplement you must “Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient . . .” You see the Certificate of Analysis provision applies to components other than dietary ingredients. Well, how are you going to test? These answers point straight back to the supplier of the dietary ingredient. The supplier of the dietary ingredient is nearly always the contact point but not always the manufacturer of the ingredient.
Thus the onus of how to test for identity of the dietary ingredient (the test that must be performed by the manufacturer of the Dietary Supplement) is going to come from the supplier of the dietary ingredient whether directly or from someone else further up the supply chain.
The supplier of the dietary ingredient, therefore, is not off the hook at all when it comes to Dietary Supplement GMPs. They are going to be increasingly pressured by their customers (the manufacturers of Dietary Supplements) to establish and share the methods of testing the identity of their product.
As time goes on with the full implementation of the Dietary Supplement GMPs it is going to be increasingly more incumbent upon the supplier of the dietary ingredient to insure that they have an appropriate test method to give over to their customers for identity determination. Yes, the Manufacturer is going to be held accountable at inspection time, but rest assured that their reliance is going to shift that burden over to the supplier.
The bottom line is that Suppliers and Consumers of dietary ingredients had best become familiar with the GMPs and what the requirements are. The Suppliers especially had best become more familiar in order to keep their business flowing. Stay Tuned.
For the purchaser of the ingredient, the Dietary Supplement GMPs are very clear. The Final Rule requires manufacturers of Dietary Supplements to establish specifications for “identity, purity, strength and composition” of the ingredients used (empohasis added). You as a manufacturer as required to do this. The supplier of the ingredient is not so required. Recall that in the transition from Proposed Rule to Final Rule the onus of regulations fell off of the manufacturers of dietary ingredients and shifted exclusively to the manufacturers of Dietary Supplements. Also, the Final Rule also allows for the use of a Certificate of Analysis for assuring the identity of components. But you must read the fine print.
As a manufacturer of a Dietary Supplement you must “Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient . . .” You see the Certificate of Analysis provision applies to components other than dietary ingredients. Well, how are you going to test? These answers point straight back to the supplier of the dietary ingredient. The supplier of the dietary ingredient is nearly always the contact point but not always the manufacturer of the ingredient.
Thus the onus of how to test for identity of the dietary ingredient (the test that must be performed by the manufacturer of the Dietary Supplement) is going to come from the supplier of the dietary ingredient whether directly or from someone else further up the supply chain.
The supplier of the dietary ingredient, therefore, is not off the hook at all when it comes to Dietary Supplement GMPs. They are going to be increasingly pressured by their customers (the manufacturers of Dietary Supplements) to establish and share the methods of testing the identity of their product.
As time goes on with the full implementation of the Dietary Supplement GMPs it is going to be increasingly more incumbent upon the supplier of the dietary ingredient to insure that they have an appropriate test method to give over to their customers for identity determination. Yes, the Manufacturer is going to be held accountable at inspection time, but rest assured that their reliance is going to shift that burden over to the supplier.
The bottom line is that Suppliers and Consumers of dietary ingredients had best become familiar with the GMPs and what the requirements are. The Suppliers especially had best become more familiar in order to keep their business flowing. Stay Tuned.
GMPs and the NBA
Since blogs are supposed to be topical this one fits right in. As I write this we are deep in the midst of the NBA Playoffs. As I was reviewing some of the action and the outcomes a thought struck me concerning the similarity between the NBA and the Dietary Supplement Industry. Specifically the new GMPs for Dietary Supplements. Now it may not be immediately obvious but there is a significant similarity that should be noted and perhaps this sports analogy will get the members of the industry aware of what is coming.
This June the NBA playoffs will conclude but the full-court coverage of the FDA’s enforcement action on companies manufacturing dietary supplements goes into full effect. While this is a nice segue into the topic it is not the heart of the matter. Here comes the reality when the enforcement actions begin. Let’s look at the NBA for a minute. The game has rules and when those rules are violated, penalties are assessed. This can range from taking the ball out of bounds through free throws through ejections from the game and even additional suspensions and fines. Well, the FDA acts as a referee in determining the “fouls” assessed individual companies when they are inspected for GMP compliance. These fouls can be an issuance of a report listing the deficiencies all the way to closing the doors of your operation and assessing heavy fines. Sure a bit of an analogous stretch but here is where the real similarity exists.
In the NBA one of the most controversial aspects of the referee’s job during these playoffs has been the assessment of “flagrant fouls.” There are multiple categories of these flagrant fouls and the assignment of category resides with the referee. The difference in categories is significant relative to whether a key player is ejected or perhaps even suspended. The controversy comes in where the referee has to make these judgments regarding the intentions and actions of the players. When it comes to the GMPs for Dietary Supplements, the same holds true. The FDA issued the Final Rule and touted loudly the “flexibility” you have as a manufacturer to achieve compliance. What is not openly stated in the regulations nor in the preamble to the regulations is the fact that the interpretation of whether you are in compliance is strictly up to the inspector (akin to the referee). The inspector has the authority to assess and make judgments as to the efforts you have made are sufficient to meet the requirements of the regulation. This is the other edge of the sword of flexibility. You may feel confident that you have taken steps to insure that the batch records, for instance, are complete and have the appropriate signatures as well as reflecting the points in the process where control is necessary. The inspector need not see it this way at all. Their interpretation of the regulation is going to likely vary from day to day, inspector to inspector and even company to company. Inspection guidances are forthcoming from FDA for their personnel to assist in this effort but in their absence you are hoping to succeed in compliance rather than being assured if you don’t take the extra steps necessary. Then when the Guidance Documents come out – will you know about them.
The Dietary Supplement GMPs are intended to be of great benefit to the consumer in insuring the safety and consistency of the products they buy while further assuring the consumer that they are getting what they are paying for. The implementation of this regulation though means that you have some work to do and June is just around the corner. Before you are cited for a “flagrant foul” and have to pay a price far greater than a free throw – seek professional help. The resources are out there and you should insure that the interpretation is kept to a minimum.
JL
Ingredient Identity - www.ingredientidentity.com
This June the NBA playoffs will conclude but the full-court coverage of the FDA’s enforcement action on companies manufacturing dietary supplements goes into full effect. While this is a nice segue into the topic it is not the heart of the matter. Here comes the reality when the enforcement actions begin. Let’s look at the NBA for a minute. The game has rules and when those rules are violated, penalties are assessed. This can range from taking the ball out of bounds through free throws through ejections from the game and even additional suspensions and fines. Well, the FDA acts as a referee in determining the “fouls” assessed individual companies when they are inspected for GMP compliance. These fouls can be an issuance of a report listing the deficiencies all the way to closing the doors of your operation and assessing heavy fines. Sure a bit of an analogous stretch but here is where the real similarity exists.
In the NBA one of the most controversial aspects of the referee’s job during these playoffs has been the assessment of “flagrant fouls.” There are multiple categories of these flagrant fouls and the assignment of category resides with the referee. The difference in categories is significant relative to whether a key player is ejected or perhaps even suspended. The controversy comes in where the referee has to make these judgments regarding the intentions and actions of the players. When it comes to the GMPs for Dietary Supplements, the same holds true. The FDA issued the Final Rule and touted loudly the “flexibility” you have as a manufacturer to achieve compliance. What is not openly stated in the regulations nor in the preamble to the regulations is the fact that the interpretation of whether you are in compliance is strictly up to the inspector (akin to the referee). The inspector has the authority to assess and make judgments as to the efforts you have made are sufficient to meet the requirements of the regulation. This is the other edge of the sword of flexibility. You may feel confident that you have taken steps to insure that the batch records, for instance, are complete and have the appropriate signatures as well as reflecting the points in the process where control is necessary. The inspector need not see it this way at all. Their interpretation of the regulation is going to likely vary from day to day, inspector to inspector and even company to company. Inspection guidances are forthcoming from FDA for their personnel to assist in this effort but in their absence you are hoping to succeed in compliance rather than being assured if you don’t take the extra steps necessary. Then when the Guidance Documents come out – will you know about them.
The Dietary Supplement GMPs are intended to be of great benefit to the consumer in insuring the safety and consistency of the products they buy while further assuring the consumer that they are getting what they are paying for. The implementation of this regulation though means that you have some work to do and June is just around the corner. Before you are cited for a “flagrant foul” and have to pay a price far greater than a free throw – seek professional help. The resources are out there and you should insure that the interpretation is kept to a minimum.
JL
Ingredient Identity - www.ingredientidentity.com
Welcome
Welcome to the Ingredient Identity Blog. Please check in for new entries or connect with the LIVE CHAT!
JL
Ingredient Identity - www.ingredientidentity.com
href="http://www.ineedhits.com/free-tools/submit-free.aspx?source=FTSFbutton">
JL
Ingredient Identity - www.ingredientidentity.com
