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Know the ins and outs of AER requirements

April 24, 2008

9 Min Read
Know the ins and outs of AER requirements

Q. When does the adverse-event reporting requirement for dietary supplements take effect?
A. The AER bill of last year was signed into law on Dec. 22, 2006. This statute takes effect one year later, so the AER reporting requirements are effective Dec. 22, 2007. Starting then, all serious adverse events associated with dietary supplements must be reported to the U.S. Food and Drug Administration. These requirements apply only to supplements, not to conventional foods, medical foods or functional foods.

Q. Are there any new supplement labeling requirements under this law?
A. By Dec. 22, all dietary supplement labels must contain the name and address or phone number of the manufacturer or distributor. But note that the name and address was already required under food-labeling regulation 21 Code of Federal Regulations sec. 101.5.

Q. Must all AEs be reported to the FDA?
A. No, only AEs that are "serious" must be reported. An adverse event is "any health-related event associated with the use of a dietary supplement that is adverse," that is, negative. Note that the AE is simply associated with the use of a supplement, not necessarily caused by. A "serious adverse event" is an adverse event that:

  • Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or

  • Requires—based on reasonable medical judgment—a medical or surgical intervention to prevent an outcome described above.

Q. Who is responsible for reporting AEs?
A. The mandatory reporting is the responsibility of the manufacturer, packer or distributor whose name appears on the supplement label as "the responsible person." A retailer is not normally the responsible person. If the retailer's name is not on the label, the retailer is not responsible for reporting any serious AEs. However, if the retailer's name does appear on the label, and if the retailer has an agreement with the manufacturer or packer of the supplement transferring responsibility, then the retailer must meet these requirements.

Q. When must the report be submitted?
A. The responsible person must send the report to the FDA within 15 business days of when the information is received at the address or phone number printed on the label or via e-mail or fax.

Q. Is there a special form that must be used for these AE reports?
A. Yes: The required form is MedWatch form 3500A, with the A meaning that these are for mandatory reports. Form 3500 is for voluntary reports (e.g., from a consumer or from a health care practitioner), which are still permitted at any time, but not required. MedWatch Form 3500A is on the FDA's Web site at

Q. What information must be included?
A. The five "minimum data elements" the FDA requires follow (with the section of the form given in parentheses):

  • an identifiable injured person (Section A)

  • an identifiable initial reporter (Section E)

  • identity and contact information for the responsible person—the manufacturer, packer or distributor (Section G)

  • a suspect dietary supplement (Section C)

  • a serious adverse event or fatal outcome (Section B)

The FDA in its Guidance for Industry further recommends: "The responsible person should actively seek information on any minimum data elements that are not initially provided by the reporter and wait to submit a serious adverse-event report to FDA until the information is obtained. FDA recommends that the responsible person document [his or her] efforts to obtain the basic elements for a serious adverse-event report."

Q. What is "an identifiable injured person"?
A. The FDA's Guidance defines as follows: [This] means providing enough information to demonstrate that an individual person was injured. For example, filling in "some consumers" under "Patient Identifier" would not be sufficient; however, a report that listed the patient identifier as "an elderly woman" or "a young man" would be sufficient because there is enough information to assess that a specific person was injured. Identifiers include one or more of the following: age or age category (e.g., adolescent, adult, elderly), gender, initials, date of birth, name, or patient identification number. A report stating that "an elderly woman had anaphylaxis" or "a young man experienced anaphylaxis" would be sufficient. If a report submitted to the responsible person refers to groups of unknown size, such as "some" or "a few" college students got anaphylaxis, the responsible person should follow up to find out the number of injured persons and then submit a separate report to the FDA for each identifiable injured person.

Q: Who is the initial reporter?
A: The initial reporter can be the injured person, a family member, a friend or neighbor or other person, such as a doctor or pharmacist—whoever first notifies the responsible person about the serious AE. The form 3500A asks for the initial reporter's contact information, and his or her e-mail address. If the initial reporter has only a secondhand or thirdhand report and does not have sufficient information, then the responsible person should try to obtain the phone number or e-mail address of a person with firsthand information of the event. Then the responsible person follows up with that next reporter to obtain the minimum five pieces of information.

Q: How is the privacy of the injured person maintained?
A: FDA states: "To protect the privacy of the injured person, he or she should not be identified by name or address; instead, the responsible person should assign a code (for example, the injured person's initials) to each serious adverse-event report that will permit cross reference with identifying information and contact information in the responsible person's records in case the responsible person needs to contact the injured person (or the initial reporter, if other than the injured person) for follow-up."

Q: What details about the "suspect dietary supplement" are required?
A: The following information should be submitted: the complete product name, including the brand name and other identifying information, for a unique identification of the product, such as the physical form (e.g., tablet, soft gel), strength (e.g., 500 mg), and container size (e.g., 90 capsule bottle). If the serious AE involves more than one supplement manufactured, packaged or distributed by the same responsible person, then that person should submit only one serious AE report, on one form 3500A. Note that a copy of the relevant supplement label must be mailed with the report, but not a sample of the product.

Q. How exactly is the MedWatch form to be submitted to the FDA?
A. Mail the MedWatch Form 3500A—along with a copy of the dietary supplement label, and any other attachments, to: FDA, Center for Food Safety and Applied Nutrition, Office of Food Defense, Communication and Emergency Response, CAERS Team, HFS-11, 5100 Paint Branch Parkway, College Park, MD 20740. Online submission may be possible in the future. But this form may not be faxed, which (one might argue) is a defect in the current procedure given that a form sent via U.S. mail could take as long as seven days.

Q. Is there any requirement to update the information contained in the initial report?
A. Yes. Any further information about the AE received within one year must be reported to the FDA within 15 business days of receiving the new information. The responsible person simply refers to the original form, and the FDA consolidates the information.

Q. How long must these records be kept?
A. For six years. Indeed, the responsible person must keep records related to any adverse-event report it receives for six years (even nonserious ones), regardless of whether the event must be reported to the FDA. These records will be requested by the FDA at any facility inspection.

Q. Isn't filing a serious AE report an admission that the suspect dietary supplement caused the event?
A. No, filing this report of a supplement associated with a serious AE is not an admission of any sort—by law, and by an explicit statement as such on Form 3500A.Also, a responsible person may include with the report a statement (which is part of any report released to the public) that explicitly denies that the product involved caused or contributed to the serious AE.

This article is not meant, and should not be construed, as a legal opinion or as legal advice, but rather is intended to provide general information and some examples as to one aspect of FDA law.

Susan Brienza is an attorney in the Denver office of the Washington, D. C.-based law firm Patton Boggs LLP. She practices in the area of regulatory compliance, in FDA law and FTC (advertising) law. Her e-mail address is [email protected].

Natural Foods Merchandiser volume XXVIII/number 12/p. 30

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