Jim Lassiter05.01.02
The modifications made to the Federal Food, Drug and Cosmetic Act (FFDCA) with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) were significant and beneficial to the dietary supplement industry. Today we hear muffled concerns from informed sources that there will be near-term efforts to "repeal DSHEA." The reality is that the repeal of an amendment to another piece of legislation is not a likely scenario. However, it is worth noting that there can be additional modifications made to FFDCA that would address perceived shortcomings that DSHEA formalized in the legislation of dietary supplements. There are strident voices in the halls of Congress who can effect such change. These are truths that the dietary supplement industry needs to recognize.
The dietary supplement industry has experienced notable growth in the number of products and consumers using these products since the passage of DSHEA. This is a less obvious truth. Yes, the data continue to come in indicating that dietary supplement sales are soft. However, the growth of sales from 1994 through this year remains steady. So, did DSHEA help or hinder the dietary supplement industry? The answer is clear.
The multiple trade associations of this industry each have vowed to "protect DSHEA." This protection has yet to meet a formidable foe or effort to remove the text inserted in FFDCA, but the anticipation is that the time is coming. The question then becomes, is there something that can or should be done to afford the protection promised? One suggestion that needs exploration has already been offered in the meetings and conferences held by and for the industry. This suggestion is that the larger industry (including dietary supplements, functional foods, nutraceuticals and other natural products) should draft, issue and garner support for passage of legislation that would address the matter on a pre-emptive basis. In other words, better to amend FFDCA with our proposals than allow those who are counted in opposition to the industry to craft such an amendment.
A large portion of this concern comes not from the legislation itself but from the resultant regulations that have issued out of DSHEA. Again this is a reminder to everyone that this is a regulated industry and ever more so since the passage of DSHEA. There are rafts of objections to how the regulations misidentify whole realms of the products it covers. There are legitimate contentions that the claims allowed are not sufficient to convey the effects (either perceived or substantiated) these products have on human physiology. The extension of this is that some of the products covered by DSHEA are not really dietary supplements but something else. This is perceptually and semantically true. However, the classification of these goods as dietary supplements is a legislative and regulatory definition and not intentionally a true description. There are very real complaints that FDA has not acted on the important issues that required address out of DSHEA (GMPs being the foremost of these), while other matters have occupied the resource-strapped agency satisfied with issuing regulations and guidelines without the ability or desire to enforce them. This last piece is critical since this lack of enforcement feeds the notion that no regulations exist. The proof of the existence of regulations lies in their application (enforcement). Without enforcement, there is little visibility of the existence of regulations and the myth of the unregulated industry grows.
Combining the situations outlined above, regulations that don't seem to fit and a pre-emptive move to trump the adverse legislative efforts and simultaneously carve out the territory desired by some in the industry appears to be a good idea. Look closely at the requirements for such a maneuver and then consider its worthiness.
The adage that folks who like sausage also are those who have the least interest in seeing it made applies here. The drafting of any piece of legislation then requires introduction of the draft into the sausage factory that is Congress.
There is no assurance that what comes out the other end will remotely resemble the input. Likely it will not. This is not exclusive to Congress but is true of any application of government. The generation of regulations out of passed legislation often misinterprets the law as written and the resultant kielbasa is frequently unpalatable. Thus when new legislation is passed there are at least two factories with the opportunity to create the end product.
Since DSHEA passed in 1994 the industry has not kept up with the changing Congress. We no longer have the widespread support in the halls of our national legislature we had in 1994. Nor are many of the same faces present any longer.
Any effort to garner support for legislation requires political capital and that is something this industry has little of. We certainly have our champions and advocates but these are in short supply. When the industry tallies the number of advocates in the existing legislature the number does not require the removal of shoes in order to tick off the final count. This situation bodes ill for attempting to gain leverage.
Regardless of the debate over the fit of some of the products in the defined regulatory scheme of today, it is the regulations issued since the passage of DSHEA that cause us the most pain. Think about that for a moment. The complaint is not that DSHEA is a poor piece of legislation, it is the resultant regulations that chafe the necks of the product producers. The address of these regulations is more likely to have positive effect than a final piece of legislation emanating from the sausage factory. Even with the passage of legislation, there remains the generation and issuance of regulations and that process can, as we have seen, yield unfavorable results. To date, the industry has embraced each piece of regulation issued in final form despite their protestations and concerns during their drafting. Now that these regulations are in effect, portions of the industry are less thrilled with the final form. When we accepted them, were we in denial that they are not what "makes sense?"
Be assured that there will likely be some effort in the near future to amend FFDCA and remove at least some of what was put in place by DSHEA. The timing of this effort likely depends on the next election cycle (November of this year). Thus, is it appropriate to perform a pre-emptive legislative strike at this time? The answer here is a resounding NO. There are implementable solutions short of going to Congress in attempts to win new friends and influence people while crafting a better DSHEA.
What are these efforts? Begin with the focus areas discussed in addressing pre-emptive strikes at FFDCA. The regulations as presented do not fulfill the promise of DSHEA. This is due in part to the system for creating and issuing such regulations. The interpretation of the legislation by the agency assigned the task (FDA) varies significantly from what the hope of the industry at the time of passage of the law. Recreating regulations that more closely meet the needs of industry through petitioning processes and strategic pressure generation from our limited number of friends in Congress makes more economic and strategic sense than putting forward a piece of legislation in hopes we will obtain what we desire. To be sure, the regulations in final form require significant effort to amend or overturn, but this effort pales in comparison to that required to pass legislation that is entirely favorable.
Since the passage of DSHEA discussions arose and then fell concerning the need, benefits and desires to "self-regulate." Some of these discussions are rising higher these days, ironically as FDA continues its lack-of-enforcement strategy and delays the issuance of the next step toward GMP regulations. We are approaching the seven-year anniversary of the issuance of a comprehensive set of GMPs created by the industry and the only efforts to apply these in a self-regulatory fashion have come from NNFA in a far-sighted approach to the issue. There have been ample opportunities to define for ourselves (as was the case in the cosmetic industry) standards and classes for our products. We should define, implement and then adhere to such standards as an industry.
The opportunities still exist but the time for application grows short. The alternative is ever more government regulation that may or may not be enforced. Additionally, witness the consumer survey FDA will undertake despite industry protestations to determine if consumers understand the messages presented in "structure/function" claims and the qualified health claims out of Pearson v. Shalala. There can only be one likely result from this survey and it will not favor the current state of regulation. If the FDA ultimately makes a case that the regulations they have in place are unenforceable and do not provide meaningful information to the consumer they confirm the notion that FFDCA requires change, so that effective regulation can be devised and implemented. It is far better to demonstrate application of standards in a self-regulatory manner.
The specter of additional legislation entering the process is very real. However, rather than be pre-emptive in effort it is a far superior idea to accomplish two things to address this concern. First, expend the dollars and efforts to solicit support for our industry in Congress. This includes approaching those the industry considers its enemies with the revelation that their agendas on some level are in line with our own. Women's Health in the first and most obvious of these issues. Second, have prepared and ready to use a piece of legislation that would only issue if the efforts to pass "DSHEA-repeal" gains momentum. Have it ready, but keep it safe until it is required in a retaliatory strike rather than issue it too soon.
As always the lynchpin of these initiatives is the industry's (all the components listed before) coming together in an effort to insure that the regulations in place make sense. If they do not work, then unite behind efforts to have them removed or notably changed. This also requires that the alternatives be applied by industry itself in self-regulatory fashion in order to demonstrate a willingness to perform and recognize the obligation to deal with those who do not.
Self-regulation is pre-emptive in itself. An industry that is willing to create and apply standards that make sense works to demonstrate to both the regulatory agencies and the consumer that the products offered are meaningful, useful and not outside the law. Therefore rather that fix something that is not broken, the alternative includes owning up to the efforts necessary to change those things not in line with the promise of DSHEA and clean our own house preemptively before there comes a set of laws that make this work impossible.NW
About the author: Jim Lassiter is principal of the Lassiter Group, Laguna Beach, CA. He can be reached at 949-497-3466; Fax: 949-497-9669; E-mail: jlassiter@worldnet.att.net.
The dietary supplement industry has experienced notable growth in the number of products and consumers using these products since the passage of DSHEA. This is a less obvious truth. Yes, the data continue to come in indicating that dietary supplement sales are soft. However, the growth of sales from 1994 through this year remains steady. So, did DSHEA help or hinder the dietary supplement industry? The answer is clear.
The multiple trade associations of this industry each have vowed to "protect DSHEA." This protection has yet to meet a formidable foe or effort to remove the text inserted in FFDCA, but the anticipation is that the time is coming. The question then becomes, is there something that can or should be done to afford the protection promised? One suggestion that needs exploration has already been offered in the meetings and conferences held by and for the industry. This suggestion is that the larger industry (including dietary supplements, functional foods, nutraceuticals and other natural products) should draft, issue and garner support for passage of legislation that would address the matter on a pre-emptive basis. In other words, better to amend FFDCA with our proposals than allow those who are counted in opposition to the industry to craft such an amendment.
A large portion of this concern comes not from the legislation itself but from the resultant regulations that have issued out of DSHEA. Again this is a reminder to everyone that this is a regulated industry and ever more so since the passage of DSHEA. There are rafts of objections to how the regulations misidentify whole realms of the products it covers. There are legitimate contentions that the claims allowed are not sufficient to convey the effects (either perceived or substantiated) these products have on human physiology. The extension of this is that some of the products covered by DSHEA are not really dietary supplements but something else. This is perceptually and semantically true. However, the classification of these goods as dietary supplements is a legislative and regulatory definition and not intentionally a true description. There are very real complaints that FDA has not acted on the important issues that required address out of DSHEA (GMPs being the foremost of these), while other matters have occupied the resource-strapped agency satisfied with issuing regulations and guidelines without the ability or desire to enforce them. This last piece is critical since this lack of enforcement feeds the notion that no regulations exist. The proof of the existence of regulations lies in their application (enforcement). Without enforcement, there is little visibility of the existence of regulations and the myth of the unregulated industry grows.
Combining the situations outlined above, regulations that don't seem to fit and a pre-emptive move to trump the adverse legislative efforts and simultaneously carve out the territory desired by some in the industry appears to be a good idea. Look closely at the requirements for such a maneuver and then consider its worthiness.
The Sausage Factory
The adage that folks who like sausage also are those who have the least interest in seeing it made applies here. The drafting of any piece of legislation then requires introduction of the draft into the sausage factory that is Congress.
There is no assurance that what comes out the other end will remotely resemble the input. Likely it will not. This is not exclusive to Congress but is true of any application of government. The generation of regulations out of passed legislation often misinterprets the law as written and the resultant kielbasa is frequently unpalatable. Thus when new legislation is passed there are at least two factories with the opportunity to create the end product.
Working with our Friends
Since DSHEA passed in 1994 the industry has not kept up with the changing Congress. We no longer have the widespread support in the halls of our national legislature we had in 1994. Nor are many of the same faces present any longer.
Any effort to garner support for legislation requires political capital and that is something this industry has little of. We certainly have our champions and advocates but these are in short supply. When the industry tallies the number of advocates in the existing legislature the number does not require the removal of shoes in order to tick off the final count. This situation bodes ill for attempting to gain leverage.
It's the Regulations Stupid
Regardless of the debate over the fit of some of the products in the defined regulatory scheme of today, it is the regulations issued since the passage of DSHEA that cause us the most pain. Think about that for a moment. The complaint is not that DSHEA is a poor piece of legislation, it is the resultant regulations that chafe the necks of the product producers. The address of these regulations is more likely to have positive effect than a final piece of legislation emanating from the sausage factory. Even with the passage of legislation, there remains the generation and issuance of regulations and that process can, as we have seen, yield unfavorable results. To date, the industry has embraced each piece of regulation issued in final form despite their protestations and concerns during their drafting. Now that these regulations are in effect, portions of the industry are less thrilled with the final form. When we accepted them, were we in denial that they are not what "makes sense?"
Be assured that there will likely be some effort in the near future to amend FFDCA and remove at least some of what was put in place by DSHEA. The timing of this effort likely depends on the next election cycle (November of this year). Thus, is it appropriate to perform a pre-emptive legislative strike at this time? The answer here is a resounding NO. There are implementable solutions short of going to Congress in attempts to win new friends and influence people while crafting a better DSHEA.
What are these efforts? Begin with the focus areas discussed in addressing pre-emptive strikes at FFDCA. The regulations as presented do not fulfill the promise of DSHEA. This is due in part to the system for creating and issuing such regulations. The interpretation of the legislation by the agency assigned the task (FDA) varies significantly from what the hope of the industry at the time of passage of the law. Recreating regulations that more closely meet the needs of industry through petitioning processes and strategic pressure generation from our limited number of friends in Congress makes more economic and strategic sense than putting forward a piece of legislation in hopes we will obtain what we desire. To be sure, the regulations in final form require significant effort to amend or overturn, but this effort pales in comparison to that required to pass legislation that is entirely favorable.
The Need for Self-Regulation
Since the passage of DSHEA discussions arose and then fell concerning the need, benefits and desires to "self-regulate." Some of these discussions are rising higher these days, ironically as FDA continues its lack-of-enforcement strategy and delays the issuance of the next step toward GMP regulations. We are approaching the seven-year anniversary of the issuance of a comprehensive set of GMPs created by the industry and the only efforts to apply these in a self-regulatory fashion have come from NNFA in a far-sighted approach to the issue. There have been ample opportunities to define for ourselves (as was the case in the cosmetic industry) standards and classes for our products. We should define, implement and then adhere to such standards as an industry.
The opportunities still exist but the time for application grows short. The alternative is ever more government regulation that may or may not be enforced. Additionally, witness the consumer survey FDA will undertake despite industry protestations to determine if consumers understand the messages presented in "structure/function" claims and the qualified health claims out of Pearson v. Shalala. There can only be one likely result from this survey and it will not favor the current state of regulation. If the FDA ultimately makes a case that the regulations they have in place are unenforceable and do not provide meaningful information to the consumer they confirm the notion that FFDCA requires change, so that effective regulation can be devised and implemented. It is far better to demonstrate application of standards in a self-regulatory manner.
Be Prepared
The specter of additional legislation entering the process is very real. However, rather than be pre-emptive in effort it is a far superior idea to accomplish two things to address this concern. First, expend the dollars and efforts to solicit support for our industry in Congress. This includes approaching those the industry considers its enemies with the revelation that their agendas on some level are in line with our own. Women's Health in the first and most obvious of these issues. Second, have prepared and ready to use a piece of legislation that would only issue if the efforts to pass "DSHEA-repeal" gains momentum. Have it ready, but keep it safe until it is required in a retaliatory strike rather than issue it too soon.
As always the lynchpin of these initiatives is the industry's (all the components listed before) coming together in an effort to insure that the regulations in place make sense. If they do not work, then unite behind efforts to have them removed or notably changed. This also requires that the alternatives be applied by industry itself in self-regulatory fashion in order to demonstrate a willingness to perform and recognize the obligation to deal with those who do not.
Self-regulation is pre-emptive in itself. An industry that is willing to create and apply standards that make sense works to demonstrate to both the regulatory agencies and the consumer that the products offered are meaningful, useful and not outside the law. Therefore rather that fix something that is not broken, the alternative includes owning up to the efforts necessary to change those things not in line with the promise of DSHEA and clean our own house preemptively before there comes a set of laws that make this work impossible.NW
About the author: Jim Lassiter is principal of the Lassiter Group, Laguna Beach, CA. He can be reached at 949-497-3466; Fax: 949-497-9669; E-mail: jlassiter@worldnet.att.net.
