AER missing from FDA guidance
records of production and distribution that still falls short of
taking a stance on the issue of adverse events reporting.
The guidance responds to questions concerning the 2002 Public Health Security and Bioterrorism Preparedness and Response Act. To clear up the confusion surrounding these regulations, the US Food and Drug Administration (FDA) answered questions pertaining to all food and drug products, which includes dietary supplements.
The issue of requiring manufacturers to report adverse events to the FDA has been a hot topic in the nutraceutical industry as companies want to assert their credibility. This latest guidance reveals a loophole whereby companies can still get away with not reporting consumer health problems resulting from their product.
In June, an amendment to the Food, Drug and Cosmetic Act that would oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse events reports (AERs) was introduced to the applause of industry associations.
Senate bill 3546, would require supplement labels to include a telephone number for the reporting of serious advert events, and require supplement companies to pass on these reports to FDA within 15 days.
The dietary supplements industry is regulated by DSHEA, the 1994 Dietary Supplements Health and Education Act. This law has drawn criticism from some quarters since it does not require the same pre-market approval for supplements as for prescription drugs.
In the FDA's latest food guidance, entitled "Questions and answers regarding establishment and maintenance of records (Edition 4)", question 1.4 asks:
"Are over the counter vitamins covered by this regulation?" The answer: "Yes. Food in this regulation has the same meaning as under section 201(f) (21 U.S.C. 321(f)) of the Federal Food, Drug, and Cosmetic Act. Food includes dietary supplements, such as over-the-counter vitamins (21 U.S.C. 321(ff))."
Adverse events are by no means only associated with safety of specific ingredients; they might also stem from supply chain issues, contamination or tampering. And it is these supply chain issues that the newest guidance covers.
The questions in the document range from concerns over whether the regulations apply to Halloween candy or whether they apply to charity soup kitchens. But the FDA's answer remains basically the same throughout:
"The facility must establish and maintain records for food received and released that identify the nontransporter and transporter immediate previous sources and immediate subsequent recipients…"
The motivation for these records is made clear:
"Such records could be helpful to both the facility and FDA in the event of a trace back or trace forward investigation," states the document.
However, requiring records of any adverse events be submitted to the FDA is noticeably missing from the guidance. The agency stipulates that if foods are believed to have been contaminated this must be reported immediately, but does not specify reactions arising from an ingredient itself be reported:
"Under these provisions, any existing relevant records must be made available to FDA as soon as possible, not to exceed 24 hours from the time of request, if FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals."
It remains to be seen if the AER bill will become regulation and iron out the legislative gray area that has been pitting responsible industry members against others they say threaten the integrity of the industry.
