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Zantac and NDMA: No Safe Level

Zantac and NDMA Lawsuits

Lawsuits have been filed against the makers of Zantac, and many contain language that refers to the Federal Drug Administration (FDA) and what the agency considers to be levels of NDMA beyond those which are safe. This would lead many to believe that there is a “safe level” of the carcinogenic chemical that would be allowed to be within our drug supply, and that is not the case. 

In the context of such a lawsuit, the attorney for the plaintiff should not use language referring to any safe amount of NDMA.  21 U.S. Code Section 351 relates to adulterated drugs and devices and says that a drug is considered to be adulterated if it includes a substance that is not listed on its label.  Recalls have occurred when even totally harmless unlabeled substances have been found within a drug batch.  21 U.S. Code Section 352 addresses mislabeled medications containing false or misleading information.  A drug product can be mislabeled and not adulterated, but all adulterated medications are also misbranded.

Zantac and NDMA – There Are No “Safe Levels”

The “safe levels of NDMA” referred to by the FDA were those that had been established by the Environmental Protection Agency related to the levels found within drinking water sources.  NDMA is not a substance approved by the FDA as either an inactive or active ingredient, and the agency would not approve a product that has the substance as an ingredient.  Any product that contained NDMA and had been previously approved by the FDA would be a misbranded or adulterated drug.

NDMA is a Poison

The Environmental Protection Agency (EPA) made a determination as early as the 1980s that NDMA was an extremely hazardous substance.  Essentially, NDMA is a poison.  The Zantac defendants sold consumers a defective, misbranded, adulterated drug that was poisonous.  

The use of the term “poison” when referring to NDMA is not intended to be dramatic.  The substance has been used (successfully) in poisoning murders in at least four documented cases.  Three of those cases ended in murder convictions, and in the fourth case, the defendant poisoned himself with NDMA and died prior to trial.

The formation of NDMA in the Zantac products is dependent on temperature, and the levels of the substance rise at higher temperatures.  The FDA found that NDMA in Zantac/Ranitidine begins to form at room temperature, and that is important because the labels did not contain any instructions to store the drugs in refrigeration.  Because there was no advice to refrigerate the products given to the retailers or consumers, it can be assumed that most every Zantac/Ranitidine pill ever manufactured began the process of converting to NDMA outside of refrigeration, and continued through the supply chain and while in possession of the consumer.

Below is a news clip from last year regarding Zantac and NDMA.

In Short

  • There is no acceptable level of NDMA that can be contained within an FDA-approved drug.  If it is found in a drug, that product is misbranded and/or adulterated.
  • According to FDA results, unless the Zantac product was always stored in refrigerated temperatures, it would be contaminated with NDMA, and therefore misbranded and adulterated.
  • Because the FDA does not approve misbranded and/or adulterated drugs, the Zantac products used by consumers were not FDA approved.

Sacramento Zantac Lawyer 

I’m Ed Smith, a Sacramento Zantac Lawyer. If you or a family member have received a cancer diagnosis caused by your use of Zantac or another drug, do not hesitate to phone us for free and friendly advice at (916) 921-6400 or (800) 404-5400.

I am proud to be a member of the following legal associations:

Million Dollar Advocates Forum

National Association of Distinguished Counsel.

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Our website has a Verdicts and Settlements section at which you can review some of our successful case results.

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