INSIDER Law
Mandatory AERs in Supplement Industry Fall for First Time in Five Years

Mandatory AERs in Supplement Industry Fall for First Time in Five Years

<p>Pieter Cohen, M.D., an assistant professor at Harvard Medical School, said the AER figures raise a number of unanswered questions .</p>

For the first time in five years, FDA received fewer serious adverse event reports (AERs) from dietary supplement firms.

In 2014, FDA received 2,793 mandatory AERs linked to the supplement industry. The figure is down from 3,289 AERs in 2013 and slightly below the 2012 number (2,844).

Marc Ullman, a supplement lawyer with New York-based Ullman, Shapiro & Ullman LLP, noted the mandatory AER figures had steadily increased from 2008 (687) through 2013 before falling last year.

“I wouldn’t be surprised if we see this [2014 decline in AERs] being the effect of enforcement of the GMP (good manufacturing practice) regulations and FDA action against some of these ingredients that have been directly tied to consumer injury," he said in a phone interview.

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Year                            Number of Mandatory Reports (Source: FDA)

2014                            2,793
2013                            3,289
2012                            2,844
2011                            2,037
2010                            1,014
2009                            714
2008                            687

The 2008 through 2013 data was pulled by FDA in March 2014. FDA cautions that the number of reports for a given product may change over time since the AER data is continually updated.

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Supplement distributors, manufacturers and packers must report certain AERs connected to their products, including hospitalizations, life-threatening illnesses, deaths and other adverse events that the law defines as “serious."

The AER reporting law took effect in 2008 and is known as the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

“We have known that some of the companies were slow to adopt really thorough reporting within their companies," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a phone interview. “You weren’t going to expect everybody was going to be fully compliant in 2008."

Representatives of the supplement industry said a variety of factors can impact AER reporting from year to year. For instance, Mister referenced a report by Oprah Winfrey that identified the hazards of a particular supplement, which he said resulted in a spike in AERs for that particular product.

FDA reviews AER data to identify potential safety concerns, but the reports do not reflect a conclusion by the agency that a product caused an adverse event.

The AERs don’t mean a product is unsafe, said Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA).

As Fabricant is well aware since he previously headed up FDA’s Division of Dietary Supplement Programs, the reports may omit crucial information, including a patient’s medical history, toxicology reports and other evidence that is needed to determine if there was an association between a product and an adverse reaction.

“When important information is missing from a report, it is difficult for FDA to fully evaluate whether the product caused the adverse event or simply coincided with it," FDA spokeswoman Marianna Naum said in an emailed statement.

Canadian and U.S. regulators acknowledge post-market surveillance systems don't capture all adverse reports because not all adverse events are reported. According to an investigation last year by the Atlanta Journal-Constitution, only five of 10 deaths linked to the controversial stimulant DMAA over three years were reported to FDA.

Although the U.S. Government Accountability Office (GAO) said an estimated 55,000 dietary supplements were on the market as of 2009 and half of the American population is said to take these diet and nutrient boosters, FDA received 6,307 AERs from 2008 through 2011. By comparison, the food and drug agency received more than 1.8 million AERs that relate to prescription drugs from 2008 through 2010, the GAO revealed in a 2013 report.

In its analysis of FDA inspection results from fiscal years 2008 through 2012, GAO learned that FDA identified 20 problems in connection with AER requirements. In 17 of the 20 cases, the government report observed, FDA discovered the firm did not submit a mandatory AER.

The extent of such underreporting is unknown, according to the GAO and industry representatives.

In fiscal year 2014, during inspections of dietary supplement manufacturing facilities, FDA cited three firms for failing to make a report of a serious AER, according to public data Natural Products INSIDER obtained earlier this year. One business was cited for not submitting a serious AER within 15 business days of receipt, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

“Obviously, the numbers are really low," said Rick Kingston, co-founder and president of scientific and regulatory affairs with SafetyCall International, an AER specialist that focuses on adverse event management and post-market surveillance, in a phone interview.

Kingston said when he asks supplement firms about AER reporting, “I still get the blank stares occasionally. ‘We don’t really have any adverse events.’ Which simply tells me they simply don’t have an adverse event reporting system."

Pieter Cohen, M.D., an assistant professor at Harvard Medical School, said the AER figures raise a number of questions that are left unanswered.

“How many manufacturers are compliant with the law?" he asked in a phone interview. “What percentage? We don’t know."

Cohen questioned the extent to which companies linked to spiked supplements are reporting serious AERs. Over the past decade, FDA has encountered more than 500 products that are often marketed as supplements and contain undeclared, potentially harmful ingredients, said Stephen King, an FDA spokesman. The products are most commonly marketed for bodybuilding, weight loss and sexual enhancement, he said in an emailed statement.  

“It’s possible companies that are making high-quality vitamins are meticulous about reporting, but a small company making a line of supplements with analogs of prescription drugs in there is not going to be as meticulous," Cohen said. “It’s hard to imagine any of those companies would comply with the law."

 

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