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To amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, and for other purposes.

Senate Bill 3546 and HR 6168 Passed by 2/3s majority without Hearings or Debate in the House of Representatives December 9, 2006 and No Discussion with a Voice Vote with NO Accountability in Senate by Unanimous Consent 

 To contact your elected representative: http://www.house.gov/writerep/

Sponsors: Rep. Christopher Cannon [R-UT] Introduced 9/25/2006 and Senator Rep Orin Hatch sponsored SR 3546 

Are Dietary Supplements a Danger and Menace to the Public? - NO!

For more than nine years, the American Association of Poison Control Centers have reported no mortality associated with multivitamins and incredibly low mortality and morbidity associated with dietary supplements.  Other substances readily available to the public are not under assault, including sugar that feeds fungus and cancer cells, table salt associated with high blood pressure and even tobacco products that are proven carcinogens causing cancer.  There are no laws in the hopper to remove salt, tobacco or drugs with known dangerous side effects from the market, but woe to the natural dietary supplements that are becoming ever more popular because in most instances they work, while nutritionally promoting your well-being!

Wake up government - maybe there are not as many double-blind studies costing millions that we want, but when millions of people over a hundred years tell you something works to make them feel better you should realize it doesn't take a veterinarian to recognize an elephant and quit treating constituents like we are uneducated dwebes that believe anything we hear!  The bottom line is a high percentage of the general public take natural dietary supplements and ingredients because for millions they work and work safely and inexpensively. 

Prevention versus Cure - Why is Common Sense Forgotten in HR 6168?

The main-stream medical community and government for the most part are dedicated to curing instead of preventing disease - a priority that has led to the healthcare crisis we are embroiled in today in America.  The cost of prevention is miniscule compared to the astronomical expense to cure.  And have all those high-priced studies proven pharmaceuticals won't kill or cause serious complications after approval for public consumption - NO!   It doesn't mean we outlaw drugs; just that we recognize the risk and judge judiciously what we ingest in our bodies and quit attacking the dietary supplement industry that grosses each year less than the pharmaceuticals spend on advertising ($15 vs $23 Billion)! 

The dietary supplement industry is a risk to pharmaceuticals not because it is a high profit industry with its unpatentable natural products, but because people living a healthy lifestyle while properly using quality dietary supplements and dietary ingredients don't get sick nearly as often as those who do not and consequently don't need as many prescription drugs often accompanied by dangerous side-effects. 

What's In HR 6168 That is Such a Threat to Natural Dietary Supplements?

Will the dietary supplement and ingredient manufacturers have to spend the $200-500 million dollars required to substantiate a safe benefit in a pharmaceutical drug?  That will mean only big Pharma can afford to market dietary supplements and prices will spiral out of sight to the public.  Am I just being paranoid knowing the small corporations now doing the great preponderance of manufacturing and marketing dietary supplements and dietary ingredients will disappear due to lack of funds to qualify their products taken safely for years?  You be the judge.

Are the small corporations now doing the great preponderance of manufacturing and marketing dietary supplements and dietary ingredients  damned if they do and damned if they don't; in either case risking removal from the market by autocratic bureaucratic decision without legitimate scientific review?  According to HR 6168, a dietary supplement or dietary ingredient is guilty by association with a pharmaceutical If a person is taking a dietary supplement and a drug and an adverse reaction occurs due to the prescription drug (those over 60 now take an average of 2.8 prescription drugs daily). 

Under HR 6168, the dietary supplement has to be reported together with the drug in an adverse event report and thus a risk is implied even though none probably exist for the dietary supplement or dietary ingredient.  If proper biological testing - not statistical risk analysis - on the dietary supplement or dietary ingredient isolated in an adverse health incident indicates significant cause attributable to the dietary supplement or dietary ingredient, then appropriate warning or removal is warranted.

But that is not what HR 6168 requires or allows.  As an example, if you are taking Celebrex (now limited on the market due to enhanced risk of an adverse health event) and CoEnzyme Q10 and have a heart attack, under HR 6168, the CoQ10 could be taken off the market while the Celebrex would remain, even though the Celebrex was the culprit with no duplicity or contribution to the adverse health event by the CoQ10.  This is not only unfair, HR 6168 is Un-American and a dangerous precedent of government intervention in personal freedoms with guilty until proven innocent.

The dietary supplement or dietary ingredient covered under HR 6168 is guilty by association - not fact.  But the implication left with the public is there is a danger present in taking the dietary supplement or dietary ingredient.  In reality, the danger is to the taxpayer's pocket book for the $5 million tax dollars this stupid bill will require to implement and the wasted extra burden on already overburdened doctors on still more paperwork and the understaffed FDA with legitimate health dangers to review. 

It is extremely troubling that no immediate risk exist to the pharmaceutical drug involved that actually caused the adverse event that could remove it from the market, no matter how dangerous.  A drug seemingly has to repeatedly kill to be considered dangerous and then all-to-often only the warning on the label is made larger!  

Quality companies that spend millions removing toxins and mercury from their fatty acid products would be lumped into a category of all omega 3 fatty acids, including the fast-buck artist with inferior products.  This is equivalent to saying that if a brake defect in a particular make of automobile is determined to cause accidents, then all gasoline could be removed from the market because in all of the damaged cars, gasoline had a high statistical risk associated with the adverse event by being  present in 100% of the adverse brake incidents! 

Supplement companies in general cannot afford the millions of dollars this would require for additional compliance, particularly since the quality companies have done nothing to warrant the expenses and compliance test are not even defined in HR 6168.  Note the same unreasonable and scientifically deficient tests of risk are not applied to pharmaceutical drugs. Why, when they are proven to kill thousands if not millions from adverse side-effects?  It is similar to being told you will receive the death penalty for exceeding the speed limit, but you won't be told what the speed limit is until you break it!  Sound absurd?  So does HR 6168.

To equate this bill to every-day life, if you were a witness to a murder and tried to give the victim medical aid, although in no way involved - just innocently there at the crime scene - HR 6168 would punish you the same as the actual murderer, even though you were totally innocent and tried to help, not hurt.  You are guilty by association, or for just being there. There is no trial, but only a determination by an appointed bureaucrat told to judge based on bogus evidence.  A risk analysis would say there is a high probability the murderer was at the scene of the crime and since you were, there is a statistically significant risk you are the murderer!  It gets worse - the actual murderer is probably not sought after and goes free and only you are prosecuted!  Frightening? You bet. How can any rational person think this is equitable or sensible law in regard to dietary supplements, but this is what HR 6168 proposes.

Comment:  The amount of intake of dietary supplements suggested varies greatly by manufacturer depending on the process of manufacture.  This law makes no distinction between dietary supplement sources or intake in a given incident - all are lumped together without regard to quality, consumption or consumer compliance with recommended intake. This is a scientifically flawed clause as most substances in huge amounts are toxic, from table salt to water and certainly pharmaceutical drugs! 

Why isn’t there a law proposed with regard to pharmaceuticals in excess?  Why not outlaw water because if you drink 5 gallons in a minute you will drown and be dead and there are significant drownings annually!  This is nonsensical in rational thought, but it is in HR 6168 to assure almost any dietary supplement or dietary ingredient would be subject to removal from the market based on unreasonable standards.  Understand the Secretary will not need proven risk from true biological testing of the isolated dietary supplements or dietary ingredients,  just a hunch based on statistical risk analysis that is easily manipulated.  Statistics can be massaged for a desired outcome and this proposed HR 6168 invites such inappropriate conclusions whether by error or design. 

These are unnecessary laws disguised as consumer protection when in fact they are a tool sought by the pharmaceutical industry to unjustly allow dietary supplement removal by the unjust premise of guilty until proven innocent at the sole discretion of the beauracracy funded in great part by the same pharmaceutical industry.  Why no debate and no accountability by the politicians?  You be the judge!

THE PRO BILL VIEW

Why the Natural Products Association (formerly NNFA) Supports the AER Bill ( http://nnfa.convio.net/site/PageServer?pagename=ic_AERbill )

The Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “AER Bill”)— legislation that resulted from political compromise among a number of senators with input from industry—was introduced June 21, 2006. If this bill becomes law, it would amend the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements.

As word of AER-related legislation spread, it has become clear that many in the industry can benefit from information regarding the background of this bill, including what would be required (and of whom), what is not required, and the likely impact of the legislation on the industry. The biggest benefit of the bill to the dietary supplement industry is that it will thwart continuing press articles stating that dietary supplement safety is not monitored.

Background: Political Compromise Among Policymakers and Industry Representatives
The AER bill was the result of a political compromise and a collaborative effort among such industry Congressional Champions as Sens. Orrin Hatch and Tom Harkin, on one hand, Sen. Richard Durbin (who favors more stringent regulation of the industry, including pre-market approval), on the other hand, and Sens. Michael Enzi and Ted Kennedy (the leaders of the Senate Committee on Health, Education, Labor and Pensions), with input from members of the dietary supplement and OTC drug industries.

Throughout the legislative process, the Natural Products Association and other associations have been given the opportunity to provide input into the AER bill. The Natural Products Association team emphasized that a meaningful and fair AER bill must:

• Be limited to serious adverse events only and not require reporting just any complaint
• Include OTC drugs
• Not require retailers to report
• Be limited to products sold in the United States
• Allow third parties to report or evaluate claims
• Preempt state AER legislation

Because these objectives were achieved and for some of the reasons discussed below, the Natural Products Association Board of Directors decided to support the AER bill.

Key Provisions of the AER Bill
If the AER bill becomes law, it will require “responsible persons”— defined as manufacturers, packers or distributors of OTC drugs and dietary supplements—to submit any serious adverse event to the U.S. Food and Drug Administration (FDA) within 15 business days of learning of it. The responsible persons must submit any additional information concerning the adverse event of which they become aware within one year of the initial AER (within 15 days of receiving the additional information). The AER bill makes it unlawful to submit false serious adverse event reports to a responsible person or to FDA.

The reporting requirements do not apply to retailers who do not market products under their own name. Although the reporting requirements apply to “distributors whose name…appears on the label,” a retailer who has private label products and whose name appears on a supplement label may, by agreement, authorize the manufacturer or packer of the product to submit all of the required reports and thus not bear responsibility for reporting to FDA.

The AER bill, which will take effect one year after becoming law, defines a “serious adverse event” as an experience that results in any of the following:

• death
• a life-threatening experience
• inpatient hospitalization
• a persistent or significant disability or incapacity
• a congenital anomaly or birth defect
• requires medical or surgical intervention to prevent the above outcomes

Although the AER bill only requires that reports of “serious” adverse events be submitted to FDA, records of other types of product complaints or adverse events must be maintained for a period of six years by the responsible person. To reiterate, this recordkeeping and reporting provision does not apply to retailers.

AERs Not Proof of Causation
The AER bill provides that the submission of any serious adverse event report shall not be construed as an admission that the product caused or contributed to the adverse event. Also, all serious adverse event reports submitted to the FDA pursuant to the AER bill would be considered to be safety reports and would be available only through a Freedom of Information Act (FOIA) request and will not be disclosed unless all personally identifiable information is redacted.

Other State and Local AER Related Laws Not Identical will be Preempted
Over the past couple of years, some states have considered mandatory AER reporting in various dietary supplement related bills. The New York State General Assembly and Senate filed bills that would require mandatory reporting of all AERs—as opposed to limiting reporting to “serious” AERs. These bills are still pending, but because of the Natural Products Association’s efforts, are now unlikely to pass. Similar legislation was proposed in California last year, but did not pass, largely because the federal AER bill was imminent.

The federal AER bill would preempt all state and local laws or regulations relating to adverse events that has different requirements than this legislation. Because state and local governments will be prevented from enacting different AER reporting requirements, the industry will not be forced to adhere to varying (and potentially more onerous) requirements from state-to-state.

Impact on the Industry
The mandatory reporting requirements of the AER bill will add to manufacturers’ record keeping responsibilities. Although there has been much confusion about specifically what level of reporting would be required, “responsible persons” will only be required to report to FDA adverse events that qualify as “serious.”

These increased responsibilities on the part of manufacturers will likely benefit the industry in the long run. First, the AER bill will help improve the public perception of the dietary supplement industry by demonstrating that—contrary to media reports—the industry is regulated.

Second, over time, the recordkeeping and reporting requirements also will substantiate what many in the industry have long been saying—that the safety record of dietary supplements compares favorably to other health-related products.

Ultimately, safety reporting is the right thing to do. A responsible industry and responsible manufacturers put consumers first. An industry system that puts consumers first will increase consumer confidence and will reap the corresponding benefits.

Contributed by Daron Watts, Esq., a member of the Natural Products Association’s legal counsel team at Sidley Austin LLP.

AER Bill FAQs According to the NPA - Formerly NNFA

What is the purpose of this new bill? Why do we even need one?
If this bill becomes law, it will amend the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements. As currently proposed, it will require “responsible persons” to submit any serious adverse event to the U.S. Food and Drug Administration (FDA) within 15 business days of learning of it. The responsible persons must submit any additional information concerning the adverse event of which it becomes aware within one year of its initial AER (within 15 days of receiving the additional information).

While the industry has maintained that dietary supplements are generally safe, the withholding and subsequent release under subpoena of several thousands of AERs relating to ephedra has led some in Congress to question whether there are thousands more adverse experiences that are going unreported because the current system is voluntary.

Does the bill cover any reaction or complaint to any product I carry or manufacture—no matter how minor?
No. If the bill becomes law, it will not require reporting of all complaints; but instead will be limited to serious adverse events. “Serious” adverse events as defined in the bill are: (1) death; (2) a life-threatening experience; (3) inpatient hospitalization; (4) a persistent or significant disability or incapacity; (5) a congenital anomaly or birth defect; or, (6) require medical or surgical intervention to prevent the above outcomes. Although the AER bill only requires that reports of “serious” adverse events be submitted to FDA, records of other types of product complaints or adverse events must be maintained for a period of six years by the responsible person.

As a retailer, what am I required to do under this AER bill if a customer of mine has an adverse reaction to one of the products I carry?
If a complaint is received on a branded product, retailers will not have any obligation to report such adverse events to FDA. The manufacturer of the product—in this case the “responsible person”—will have the legal responsibility of reporting serious adverse events in connection with these products.

If a complaint is received on a private label product sold by the retailer, defined as “distributors whose name…appears on the label,” the retailer will have to make a decision about who will be the “responsible person” for the purposes of the AER bill. Such retailers will have to make a choice to either: (1) assign the reporting responsibility to the manufacturer of their private label products; or (2) to report serious adverse events themselves.

I’m a retailer. If this bill passes, what would I be required to do in the following situation: a customer comes into the store and says they had to go to the hospital because of supplement they bought from me?
What you describe would fall under the definition of “serious” according to the draft legislation. If the product is not marketed under your name, you are not required to do anything. If it was your private label product and you and the manufacturer have agreed that such complaints would be handled by them, it could be as simple as providing the phone number of the manufacturer to the customer. In this situation, there also would be no recordkeeping requirements for the retailer.

If as a retailer you have elected to handle adverse event reports yourself, you would then be required to follow the reporting and recordkeeping steps as outlined in the bill.

How does this new AER bill differ from the current reporting system?
FDA’s current system—the CFSAN Adverse Event Reporting System (CAERS)—is voluntary. The proposed AER bill would make reporting serious adverse events a legal requirement for “responsible persons,” as discussed above.

Did the Natural Products Association have any input into the proposed AER bill?
Yes. Throughout the legislative process, the Natural Products Association and other associations have been given the opportunity to provide input about the AER bill. The Natural Products Association team took care to protect retailers and the industry by emphasizing that a meaningful and fair AER bill must: (1) be limited to serious adverse events, not require reporting just any complaint; (2) include OTC drugs; (3) not force retailers to report; (4) be limited to products sold in the United States; (5) allow third parties to report or evaluate claims; and (6) include a state preemption provision. Because these objectives were achieved and for some of the reasons discussed below, the Natural Products Association Board of Directors decided to support the AER bill

Will this AER bill help trial lawyers with evidence against the industry for lawsuits?
The AER bill provides explicitly that the submission of any serious adverse event report shall not be construed as an admission that the product caused or contributed to the adverse event or otherwise caused or contributed to a death, serious injury or illness. Keep in mind that anyone—including trial attorneys—can already access dietary supplement adverse event reports under the current CAERS program.

How can the proposed AER Bill help the industry?
These increased responsibilities on the part of manufacturers will likely benefit the industry in the long run in a few ways: It will thwart continuing press articles stating that dietary supplement safety is not monitored; It will help improve the public perception of the dietary supplement industry by demonstrating that—contrary to media reports—the industry is regulated; and Over time, the recordkeeping and reporting requirements will substantiate what many in the industry have been saying—that the safety record of dietary supplements compares favorably to other health-related products.

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