FDA Inspectors Say Valisure’s Former Pharmacy Division Failed to Meet Drug Security Requirements

Inspectors say Valisure appeared to be unfamiliar with key portions of the Food, Drug and Cosmetic Act linked to drug supply chain security.

The independent laboratory and former online pharmacy Valisure, which has conducted a number of studies that uncovered toxic chemicals in various drugs and consumer products, has received a warning letter from federal regulators about deficiencies in its testing methods.

On December 5, the U.S. Food and Drug Administration (FDA) sent a letter to Valisure following inspections last year, which found that the laboratory failed to meet drug supply chain security requirements in the pharmaceutical side of its operations, which it recently broke off to become a pure testing laboratory.

Valisure is based in New Haven, Connecticut, and used to operate an on-line pharmacy along with its independent laboratory, which routinely conducts chemical analysis of drugs and products in their inventory. The company sold its ValisureRx division in April 2021.

The testing laboratory has drawn the ire of pharmaceutical companies, manufacturers and federal regulators, after discovering problems with a number of products that were widely distributed throughout the United States in recent years with toxic chemicals, which were not discovered by the makers or FDA.

Reports released by Valisure since 2018 have resulted in massive Zantac recalls, metformin recalls, sunscreen recalls, spray deodorant recalls and dry shampoo recalls.

During an inspection of Valisure’s operations conducted from May 26 to July 6, 2021, FDA officials indicate they found instances where the pharmacy division failed to investigate suspect products, failed to identify illegitimate products and failed to notify the FDA it received an illegitimate product in a timely manner.

The letter also claimed the company appeared to be unfamiliar with aspects of the Food, Drug, and Cosmetic (FD&C) Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributors and dispensers.

“In addition, FDA has observed that Valisure, LLC has never filed an annual report with the FDA as required by section 583(e)(2) of the FD&C Act. This provision requires wholesale distributors to report annually to the FDA each state by which the person is licensed and the name and address of each facility at which the person conducts business,” the letter states. “FDA has no records, including in the CDER Direct Electronic Submissions Portal, that Valisure, LLC or ValisureRx reported to the Agency during the time it was engaged in wholesale distribution.”

The letter acknowledges Valisure no longer has a pharmacy division and was not engaged in drug distribution at the time of the inspection. However, the FDA warns the issues need to be addressed if Valisure ever goes back into the pharmacy business.

Valisure’s Testing Routinely Lead to Massive Recalls

Valisure first gained national attention in September 2019, when its finding led to the discovery that all versions of the heartburn drug Zantac contained levels of the cancer-causing chemical N-nitrosodimethylamine (NDMA), at levels that exceeded 26,000 times the amounts allowed by the FDA. This resulted in Zantac being pulled from the market, and was the catalyst for thousands of Zantac lawsuits being filed by former users diagnosed with bladder cancer, esophageal cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries as the toxic chemicals passed through their bodies.

Independent investigations by Valisure have also resulted in the identification of NDMA in a variety of other generic drugs, often involving the creation of the toxic chemical as a byproduct of changes to the generic drug manufacturing processes, which the FDA failed to discovery.

In May 2021, Valisure issued a press release warning about high levels of benzene in dozens of spray sunscreen sold by several different companies, including Neutrogena, Aveeno, Coppertone, Banana Boat, CVS After-Sun and other sunscreen products. The warning cautioned consumers that exposure to the toxic benzene chemical could increase the risk of several forms of cancer. As a result of the findings several sunscreen cancer lawsuits have been filed in recent months against Johnson & Johnson, Coppertone and other.

In October 2021, Johnson & Johnson and Costco announced they had reached a settlement agreement to resolve multiple cases. However, the details of the sunscreen settlement agreement have not yet been revealed and the deal has not been finalized.

Another report issued by Valisure surfaced in November 2021, indicating the pharmacy had identified high levels of benzene in numerous brands and batches of body spray and deodorant spray products, including Old Spice, Secret, Suave, Tag and others.

Valisure noted that some inactive ingredients commonly used in body sprays in particular, such as butane, isobutane, propane and alcohol, could be potential sources of benzene contamination. Similar circumstances may have played a role in the level of benzene detected in sunscreen spray-on products.

Following the report, an Old Spice and Secret deodorant recall was issued by Proctor & Gamble, removing the products from the market and stating that benzene was not an intended ingredient of the aerosol deodorant sprays. This resulted in a growing number of deodorant recall lawsuits being filed against Proctor & Gamble.

Valisure Under Fire

Despite the profound impact Valisure has had in raising red flags about widely used drugs and consumer products, both the FDA and drug manufacturers have tried to push back against the company. The FDA conducted an inspection of the lab, with inspectors reporting violations some say were not things a small lab would need to comply with if it is not making drugs, which Valisure does not.

In addition, manufacturers targeted by Valisure’s testing have floated conspiracy theories, claiming Valisure is secretly working with plaintiffs’ attorneys to fleece the companies by using faulty testing methods. However, plaintiffs’ lawyers have said they do not intend to use Valisure’s test results in trials in many of the cases, and advocates for Valisure credit the testing laboratory with helping save lives by uncovering dangers that the FDA and manufacturers either failed to discover, or failed to disclose.