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The Dietary Supplement and Non-Prescription Drug Consumer Protection Act, S.3546
The Institute for Health Research, Inc. is a nonprofit, exempt organization. Its web site is at: www.inhere.org. Ralph Fucetola JD, a trustee of the Institute has been asked to coordinate the IHR Third Party Evaluation and Reporting System through the Adverse Event Reporting Consultants (AERC) Project, as a public service to the nutrient community. IHR expects to be cooperating with other Nongovernmental Organizations (NGOs) for this project. This is the project’s web site.
Congress recently adopted the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. Known as the “AER” law (for “Adverse Event Reporting”) the new law requires manufacturers and distributors to report all “serious” adverse events to the FDA. The bill was introduced June 21, 2006 by a group of Senators that include both critics and supporters of the industry. It was supported by major supplement industry groups. Others, including supplement consumer groups and health freedom advocates, vigorously opposed the bill. The bill was adopted on December 9, 2006 and signed into law on December 22, 2006, effective December 22, 2007. The FDA was expected to issue draft Regulations under the statute early autumn 2007.
While many people oppose more regulation of natural products, as such regulations may limit innovation and freedom of choice, this new law may result in positive outcomes as it challenges the nutrient community to keep good records. As a research institution, we hope to find, in this situation, useful data and other potentially helpful information. However, we do agree with the viewpoint that Dietary Supplements are Foods and as such should not be subject to drug-like regulations. This is law in the United States, “..the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection to the food adulteration provision…” Judge Campbell in Nutraceutical Corporation et al v Crawford.
Some suggest that AER will be bad for the industry and I understand their
concerns: we cannot repeat too often, nutrients are foods and should not be subjected to “drug-like”
controls. But consider, if AER rules had been in place a decade ago, would
Tryptophan have been banned because one manufacturer made one bad batch? Would
Ephedra have been banned if a reporting system had been in place to show the
actual safety of that herb, when used as directed? AER is not about the efficacy
of nutrients, nor is it about the safety of the particular nutrient; it is about
a "serious adverse event" relating to a particular batch of a particular
The Institute notes that the law specifically authorizes nutrient companies to hire “third parties” to evaluate and report the adverse events. In our view, this offers professionals in the field new opportunities to provide services to consumers and purveyors, while collecting safety information of research interest to the Institute.
Therefore the Institute has resolved to support the creation of a new community outreach, Adverse Event Reporting Consultants (AERC). We have obtained an appropriate web address: www.aer-consultants.com for the Project. The idea here is to create a collaborative structure, under the general sponsorship of the Institute for Health Research, in cooperation with healthcare professionals and advocacy groups, that can act in good faith, as a neutral third party, to evaluate adverse reaction claims, on behalf of consumers and purveyors alike.
AERC will not be expected to determine responsibility or corrective action and will be limited to a standard of reasonable care in determining if the allegations meet the “serious” requirement for reporting to the FDA.
We have access to experts in Biochemistry, Health, Law, Event Reporting and the like. We propose to teach marketers how to keep proper Quality Control (QC) records and provide us the information we will need to professionally determine if the “event” is “serious” enough to report.
If so, AERC will report the event to the FDA on behalf of the marketer. The Institute will use the information (with personal and company identifications removed) for its research purposes, to help prove the overall safety of Dietary Supplements. Costs and consultant fees will be recompensed by the purveyors, within the context of a nonprofit, cooperative program. While this service will be available to any purveyor of products covered by the bill, it might be most valuable to smaller vitamin purveyors who could find the availability of high quality expert review of possible adverse events cost-effective and supportive of their reputations.
Dietary Supplement Purveyors will be invited to become Associate Members of IHR (though this is not required for companies to participate in the AER screening and reporting system).
The consultancy will offer a wide variety of experts an opportunity to bring their talents and knowledge to bear on Adverse Event Reporting, to the benefit of both consumer and vitamin industry, in the context of a cooperative, independent, third-party, nonprofit setting.
Some of the law’s proponents say it will offer the industry a chance to prove what many know is true science: Dietary Supplements are safe. This expected outcome will reinforce the public's understanding that Dietary Supplements are Foods and should be treated as such. An additional approach to protecting Health Freedom is Dr. Ron Paul (R-TX)'s H.R. 2117, The health Freedom Protection Act - http://www.house.gov/paul/ While the IHR does not support specific legislation, such laws should also be considered by policy makers.
We invite experts and professionals in all appropriate fields, as well as formulators, manufacturers and distributors of Dietary Supplements and other nutritional or natural products to contact us regarding their suggestions and ideas to make this Institute Project a success. Please contact us for further information, with AERC in the subject line.
This is the revised beta version of this web page. Please check back here often as this web page will change as this project develops. Initially we were concerned with the final wording of statutory requirements; now we are concerned with regulatory requirements and private alternatives. Developments will be reported below, as they happen. As the law's reporting requirements become effective, our emphasis will shift to educating the industry and helping companies set up appropriate QC reporting systems in conjunction with the IHR Third Party Evaluation and Reporting System.
MEDIA RELEASE: Institute issues draft AER Guide
For Immediate Release [10/13/07]
Contact: Ralph Fucetola JD
Institute for Health Research
Link to Guide
NGO Strives to Help Companies Meet Standard for FDA AER Regulation
Nongovernmental Institute Sponsored Framework for Supplement Adverse Event Reporting
Summit, NJ (PRWEB) October 13, 2007 -- The Institute for Health Research announces publication of an Internet Guide for companies in the natural products industry using neutral third parties to screen and report possible adverse events resulting from taking dietary supplements or non-prescription medicines, the IHR AER Guide. The draft guide for vitamin industry companies can be found at the Guide website, AER-Consulting.com. It is intended to meet the standards suggested by the draft AER guidance announced by the FDA yesterday.
The Dietary Supplement and Non-Prescription Drug Consumer Protection Act, known as the Adverse Event Reporting (or AER) Law, goes into effect on December 22, 2007, having been signed into law one year before. To date the FDA has not issued any regulation or guidance enabling the industry to comply with the law. After indications that the agency was going to issue the new regulation in September, to allow the industry sufficient time to react, the lack of action until yesterday has been criticized. 1
Supporting natural products' compliance with the new law, while gathering important research information, the Institute has created a community outreach, Adverse Event Reporting Consultants (AERC) with the web address: www.aer-consultants.com . It has developed a collaborative structure, under its general sponsorship, in cooperation with credentialed healthcare professionals and advocacy groups, acting as a neutral third party, to evaluate adverse reaction claims, on behalf of consumers and purveyors.
The History of the FDA Bill:
Congress adopted the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. The new AER law requires manufacturers and distributors to report all "serious" adverse events to the FDA. The bill was introduced June 21, 2006 by a group of Senators that included both critics and supporters of the industry. It was supported by major supplement industry groups. Others, including supplement consumer groups and health freedom advocates, vigorously opposed the bill. The bill was adopted on December 9, 2006 and signed into law on December 22, 2006. It becomes effective December 22, 2007 and the FDA had been expected to issue draft Regulations under the statute during September 2007. Issuing them on October 12, 2007 leaves the industry little time to prepare for the new reporting requirement.
With the FDA just specifing how these events are to be recorded and reported, most organizations are concerned how to address these events responsibly. AER Consultants has, as its Counsel Ralph Fucetola JD states, "…stepped up to the plate and developed a framework that in addition to complying with the FDA mandate will allow the collection of data that will be invaluable in the future to determine drug and non-pharmaceutical interactions..." The Institute invites public comment on the implementation of this consumer and industry initiative.
Also, see the FDA comment site for its draft AER guidance:
The Institute for Health Research is a non profit, nongovernmental, exempt organization. P.O. Box 642 Summit, NJ 07901 - www.Inhere.org . Its trustees are Karen Horbatt, MBA, President of The Green Turtle Bay Vitamin Company, www.energywave.com , Ralph Fucetola JD, www.vitaminlawyer.com and Dr. Richard Podell, MD, www.drpodell.org .
GMPs & AER
Later 2007 Status Updates
10/12/07- Draft AER Guideline Announced by FDA, to be issued 10/15/07 for comments
10/13/07 - AERC Media Release
"NGO Strives to Help Companies Meet Standard for FDA AER Regulation
Nongovernmental Institute Sponsored Framework for Supplement Adverse Event Reporting"
10/09/07 - FDA must commit to AER guidance
Functional Ingredients Staff
"The detailed data required under new adverse
event reports (AERs) laws, need to be made transparent sooner rather than later,
a major trade group has told the United States Food and Drug Administration. The
Maryland-based American Herbal Products Association (AHPA) has requested what it
considers an overdue guidance document to give the supplements industry a
clearer idea of what is expected of them when the law kicks in on December 22.
FDA guidance was expected on September 19 but has yet to see the light of day.
"AHPA is charging the FDA with failing to provide necessary guidance and made its thoughts known in a formal letter to the FDA and its parent agency, the US Department of Health and Human Services (HHS). The Dietary Supplement and Nonprescription Drug Consumer Protection Act will require serious AERs to be submitted to the FDA. The Act requires the Secretary of Health and Human Services to "issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act."
"Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect," said AHPA president Michael McGuffin. "The clock is ticking."
Index - HomePage
August 3, 2007 - AER Regulations Expected...
This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation augmentation.
CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud
"08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…""
Like many people involved in the Vitamin Industry, I am a bit conflicted regarding the AER Act. I believe mandatory reporting of serious adverse events will prove Dietary Supplements to be very safe indeed; on the other hand, I can see how the system could be used to falsely paint all nutrients with the problems of a few examples of abuse or misuse. Since foods are generally recognized as safe, I doubt there will be many AE Reports... time will tell.
Drugs act by changing normal structure and function and may deplete nutrients to carry-on that effect. Many experts hold that dis-ease is predicated on nutritional deficiencies and the body needs good nutrition to return to normal structure and function.
The view has been expressed as to the need to assure that the AER system takes into account dangerous drug-drug interactions and the harmful impact drugs have on nutrients before assuming nutrients caused the serious adverse reactions.
From the June 22, 2007 Final FDA Rule on Dietary Supplement Good Manufacturing Practices
"We continue to strongly recommend that firms that receive product complaints, that are not ‘serious adverse events’ notify us about any illness or injury, because, for example, we may have additional expertise or data that may be helpful in investigating the complaint or determining whether the problem applies to more than one product…We encourage you to include our recommendations in the written procedures that you develop for handling product complaints..." (Page 629)
May 9th, 2007 - HATCH: DIETARY SUPPLEMENT GMPS FINALIZED
Completes Effort to Implement Key Aspect of DSHEA
>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”
>Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing. The GMPs are expected to be published within the next five weeks.
>“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”
February 2007 Update: Text of Letter to FDA
The following is a copy of a letter sent to the FDA.
The Vitamin Lawyer .com Consultancy
January 31, 2007
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740.
Re: Dietary Supplement and Non-Prescription Drug Consumer Protection Act, S.3546
President Bush signed the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the AER Act) into law on December 22, 2006. Several professionals in the Dietary Supplement field and I are working with Federally recognized NGOs, including the Institute for Health Research – www.inhere.org – to help especially smaller dietary supplement purveyors get ready to comply with the new law as it is implemented.
The AER Act allows third parties to interface with FDA for the purpose of screening the serious events that have to be reported from other events. We propose to do so, on an overall non-profit basis, in order to keep compliance costs as low as possible for small business purveyors while at the same time compensating professionals for their oversight. Our web site is www.aer-consultants.com .
This letter is written to ask CAERS to include us in any mailings or emailings regarding the regulations that will implement the AER Act. We may have some comments to make regarding same. AER Consultants can be reached c/o me at firstname.lastname@example.org ..."
January 2007 Update
Some recent comments by knowledgeable commentator Maury
Silverman, regarding implementing the new AER law are reprinted here for their
"Implementing "objectively" has been stated many times here, meaning to first identify concurrent use of foods and dietary supplements with drugs of any kind, be they prescription, OTC, or illegal/illicit/counterfeit. Once that is done on the MedWatch form your company now must fill out once a complaint comes to you that must be reported to FDA, the FDA should screen out drug-drug interactions & drug-nutrient interactions, (which are inherently drug problems). The current MedWatch form is very inadequate to gather this information. This is important so that:
(1) the dietary supplement ought not be blamed for a serious adverse event prompting a lawsuit against your company, or yourself since you are so numerous on the record as disbelieving and/or being delusional on this matter.
(2) The FDA can require labeling of the drug, for contra-indications, known drug-drug and/or drug-nutrient interactions. As drugs are so inherently more dangerous than foods and dietary supplements, better labeling of drugs, first, is vital importance to the nutrition industry and the public health.
(3) Drugs can be labeled for the nutritional deficiencies they cause. That goes also for alcohol, caffeine, and nicotine when poor nutrition is concurrent.
(4) More 'E' can be put into the full implementation of DSHEA. This means more quality information from the nutrition community on how to avoid adverse events, when there is concurrent usage with drugs.
The problem is too often that the medical establishment does not educate or train its practitioners on nutrition and the healing qualities of natural products. They are more likely than not, drug salespeople. From when I was a youngster, I do remember that people grew up on food and good nutrition, not DRUGS. I suggest here that you look at the article in the October 9, 2006 issue of Archives of Internet Medicine titled: "Factors Associated with Dietary Supplement Use among Prescription Medication Users". (166: 1968-74, 2006)"
Status Update as of December 23, 2006
The bill was adopted by Congress on December 9, 2006 and was signed into law on December 22, 2006. The law becomes effective over a one year period.
Status Update as of September, 2006.
6/21/2006: Introductory remarks on measure. (CR S6285-6287)
6/21/2006: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
6/28/2006: Committee on Health, Education, Labor, and Pensions.
Ordered to be
reported with an amendment in the nature of a substitute favorably.
9/5/2006: Committee on Health, Education, Labor, and Pensions.
Senator Enzi with an amendment in the nature of a substitute. With written
report No. 109-324.
9/5/2006: Placed on Senate Legislative Calendar under General Orders. Calendar No. 586.
Report of the Senate Committee: "Contracting of Reporting Obligation: The committee is aware of concerns that parties responsible for reporting have expressed they may not have the expertise to determine if an adverse event falls within the definition of `serious'. The committee recognizes that many manufacturers have indicated they will contract their reporting function to a third party which has greater medical expertise. S. 3546 allows such contracting, with the understanding that the manufacturer, packer or distributor whose name appears on the label of the product still maintains ultimate responsibility for reporting under the law."
FDA information on voluntary Adverse Event Reporting
[Information partially superseded by AER Law.]
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