Consumer Advocacy Groups Prompt FDA Investigations

.
Mike Rozembajgier
08-05-2011

By Mike Rozembajgier

As an example of efforts by third parties to drive the regulatory environment for food and consumer products, a recent study conducted by two consumer groups has prompted investigations by the Food and Drug Administration (FDA) and the New York State Department of Agriculture and Markets (NYSDAM). This third party activism presents yet another regulatory challenge for manufacturers and distributors of consumer products.

After an investigation commissioned by the Empire State Consumer Project and Food & Water Watch found dangerous levels of arsenic in apple juice products sold in the U.S., both organizations co-signed a letter alerting the FDA to the findings and calling for FDA action to screen and prevent heavy metal contamination in juice products.

According to the study, one sample of Mott’s Apple Juice contained 55 parts per billion of arsenic. Although the FDA does not have guidelines for arsenic levels in juice products, the Environmental Protection Agency’s arsenic limit of 10 parts per billion in drinking water provides a comparable example.

In a press release announcing the study’s findings, Judy Braiman, Executive Director of the Empire State Consumer Project, said that “It is past time for the FDA to set a limit on a toxic substance like arsenic with long term health effects in the juice that kids drink.”

The groups went on to note that two-thirds of the apple juice that Americans consume is imported from China, and, “Given how pervasive poorly regulated Chinese food exports are in our food supply, the FDA has a responsibility to focus its attention on imported foods, especially those that are most often eaten by children.”

The FDA and the NYSDAM performed their own follow-up investigations at the same Mott’s plant in New York State that had been subject to the private investigation. Both agencies refuted the consumer group’s claims, finding acceptable arsenic levels in apple concentrate from both U.S. and Chinese sources. The FDA then notified the Mott’s plant that it had found no problems requiring action.

Trumpeting the FDA’s findings, Chris Barnes, spokesman for Dr. Pepper Snapple Group, which owns Mott’s, said that the FDA had confirmed “what we have always maintained – that our products are safe.”

But the quick response by both the FDA and NYSDAM illustrates the authority and effectiveness that third party groups can exercise when seeking to remake the regulatory environment. Had the FDA not refuted the findings, Mott’s may well have faced an immediate recall.

As the consumer groups review the FDA and NYSDAM’s reports, they will likely look for any opportunities to counter the regulatory findings and continue to look for ways to influence FDA policy. Companies must be proactive in working with regulators in order to demonstrate the safety of their products and the precautions in place to protect consumers. Doing so will avoid placing regulators in a position where third-party groups can influence regulatory policy according to their own agendas.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Leave a Reply

Get Ready Are You Ready Test Your Recall Test Your Recall