Food Recall Resource

Keurig Dr. Pepper Bottled Water Fails to Meet FDA Standards

Beverage industry giant, Keurig Dr.  Pepper (KDP), is busily working with retailers to pull Peñafiel brand mineral water from store shelves.  The company recently performed an independent inspection of their products, which revealed certain bottled water products contain higher levels of arsenic than are allowed by FDA standards.

KDP is voluntarily withdrawing Peñafiel brand unflavored mineral spring water products from the market.  The beverage company imports the product from Mexico before distributing it to stores.  KDP oversees production facilities and testing.  Quality tests of the product conducted by an independent laboratory, but requested by KDP, found arsenic in the bottled water exceeding U.S. Food and Drug Administration (FDA) standards of 10 parts per billion (ppb).

Which Products are Subject to this Voluntary Withdrawal?

All sizes of unflavored Peñafiel mineral spring water products including all date codes are subject to this withdrawal.  Anyone who has this product in their home can return it to the place of purchase for a refund.  Peñafiel was available for sale at Target and Wal-Mart, among other retailers.  Arsenic is deadly in large enough doses, so don’t risk consuming this product.  Throw it out or return it.

There are no other Keurig Dr Pepper products known to contain arsenic at this time.  Peñafiel is the only subsidiary brand that is subject to this withdrawal.  Peñafiel is not hugely popular in the U.S., so the potential for harm is relatively small here.

FDA standards

Arsenic in Bottled Water?

Arsenic is a naturally occurring deadly poison.  It can certainly be present in the water tables that are the source of natural mineral water products.  Where arsenic is present, levels vary over time.  In response to the findings of arsenic in the water supply for their product Peñafiel, KDP installed more advanced filtration systems.  The company says the product is now well within FDA standards and should continue to be so for the foreseeable future.

How the FDA Regulates Bottled Water Products

The FDA protects consumers who buy bottled water by enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act).  This is a federal law that holds manufacturers responsible for producing food products that are safe to consume and labeled truthfully.

The FDA standards in the FD&C Act that apply specifically to bottled water include:

  • Standard of identity regulations, which define the different types of bottled water.
  • Standard of quality regulations, which set FDA standards for maximum levels of contaminants allowed in bottled water.  Contaminants may include chemical, physical, microbial, and radiological materials.
  • Current good manufacturing practice (CGMP) regulations, which defines industry standards and requires bottled water to be produced in sanitary conditions.

FDA Standards for Different Types of Bottled Water

One of the standards the FDA regulates is the labeling and nomenclature of bottled water products.  If you’ve ever wondered whether your “spring water” really comes from a spring, here’s a rundown of FDA standards for labeling bottled water:

  • Artesian Well Water– Must be water from a well that taps an aquifer that rises to the surface mostly from artesian pressure.
  • Mineral Water – Must be water containing at least 250 parts per million dissolved solids that flows from an underground source.  Minerals must be naturally occurring in the water and cannot be added later.
  • Spring Water – Must be water from a spring or through a borehole that taps the underground formation of water leading to a spring.
  • Well Water – Must be water from a drill hole in the ground that taps an aquifer
  • Municipal Water – May be tap water.  Some bottled water is tap water that is treated (purified) prior to bottling.

Ensuring FDA Standards of Quality and Safety

The federal government did not have any quality standards for bottled water until 1973.  Previous standards applied only to public drinking water, not specifically to water in sealed containers.

The U.S. Environmental Protection Agency (EPA) regulates tap water.  The FDA has the responsibility to make sure standards for bottled water match the standards set for tap water by the EPA.  As such, the EPA establishes standards for contaminants and the FDA either conforms to that standard or determines it is not a standard that applies to bottled water.

FDA standards for bottled water don’t always match up with EPA standards.  For lead, for example, the EPA allows for levels in tap water to reach 15 ppb because water traveling through lead pipes can leach the metal as it flows.  For bottled water, FDA standards are more stringent, with lead concentration levels capped at 5 ppb.

CGMP regulations keep bottled water safe for consumers.  Producers that bottle water must abide by CGMP regulations and inspections.  CGMP regulations for bottled water include:

  • Sampling and analyzing the water for sanitation and safety
  • Proper plant design
  • Proper equipment design
  • Bottling procedures
  • Record keeping

The FDA is also responsible for overseeing bottling plant inspections as part of the agency’s food safety program.  KDP deserves a lot of credit for independently sampling and testing their bottled water product long before the FDA was made aware of the contamination.  Their quality assurance standards and swift corrective action may have saved lives.

 A Voluntary Withdrawal vs.  a Voluntary Recall

The FDA tracks and publishes three different kinds of consumer alerts for products that do not meet FDA standards.  These alerts include:

  • Safety AlertsSafety alerts are internally generated reports from the FDA to the public detailing the potential dangers of a product under their purview.
  • RecallsRecalls are the removal of products from the marketplace when the FDA has legal standing to force action.  Most of the time recalls are voluntary, but not always.  The things that prompt recalls are major violations of FDA standards that may present a danger to public health.
  • Market Withdrawals – Market withdrawals are the voluntary removal of products from the marketplace due to violations that are too minor to warrant legal action by the FDA.  KDP’s recall of Peñafiel bottled water is a voluntary market withdrawal.

Have Questions about Bottled Water and FDA Standards?

Manufacturers that sell bottled water have the same basic responsibility to the public as food producers do.  Their responsibility includes providing a quality, wholesome product that will not make consumers sick.  Furthermore, like food producers, water bottlers can and should be held financially responsible for any harm their products cause.

If you or someone you love is sick due to contaminated bottled water, contact Bad Food Recall.  If you are sick as a result of a product that does meet FDA standards, you may be able to take legal action.  To find out more, call Bad Food Recall at 1-877-534-5750 or contact us online.



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