March 8, 2022
A distributor of dietary supplements that violated manufacturing rules and claimed its products could cure, mitigate, treat or prevent such diseases as cancer and diabetes has been ordered to cease its operations, the U.S. Department of Justice (DOJ) announced Tuesday.
Salud Natural Entrepreneur Inc. (Salud), of Waukegan, Illinois, cannot resume operations unless its facility complies with cGMPs (current good manufacturing practices) and meets other conditions specified in a consent decree of permanent injunction entered in U.S. District Court.
Salud, its owner, Hector Pablo Oliva, and two other employees working in production and quality control (QC), distributed adulterated and misbranded supplements and unapproved drugs, in violation of the Federal Food, Drug and Cosmetic Act (FDCA), DOJ alleged in its complaint. Salud manufactured its products from components shipped to the company from outside the state of Illinois, including India, according to DOJ.
“Current good manufacturing regulations are in place to protect consumers, and it is imperative that dietary supplement manufacturers comply to ensure this protection,” Judy McMeekin, FDA’s associate commissioner for regulatory affairs within the Office of Regulatory Affairs, said in a DOJ news release. “We also hold manufacturers responsible when their product is inappropriately labeled with claims to cure or prevent disease, to protect consumers who are unknowingly scammed by false or misleading claims.”
History of cGMP, labeling violations
Salud has a long history of regulatory violations, beginning with a 2015 inspection, according to DOJ’s lawsuit and an FDA dashboard. FDA that year issued a Form 483 to Salud for 11 inspectional “observations” related to cGMPs, product labeling and unapproved new drug violations, DOJ said.
An FDA dashboard shows Salud received a regulatory classification in 2015 (official action indicated) (OAI) that means objectional conditions were found and regulatory action is recommended. That led to a 2016 warning letter related to the issues FDA identified above. Despite Salud’s promises to resolve the issues, FDA cited the company for additional regulatory infractions during inspections that ended in 2018, 2020 and 2021, according to DOJ’s lawsuit.
In 2018, FDA identified cGMP observations, as well as labeling that made disease claims, leading to another OIA classification. The defendants did not respond to the Form 483, resulting in a regulatory meeting between FDA and two of the defendants, DOJ alleged. During the meeting, Oliva advised FDA that Salud would remove the disease claims from its website and send new labels to FDA, but no such documentation was provided, the lawsuit added.
Instead, FDA identified additional problems during subsequent visits to Salud’s facility.
During an inspection that began in August 2019 and ended in January 2020, FDA identified 28 inspectional observations related to such varied issues as QC and labeling that made disease claims, according to DOJ’s lawsuit. The same inspection revealed defendants neglected “to reject a lot of Senna Leaves Powder that tested positive for salmonella,” DOJ alleged.
Although FDA verified the presence of salmonella through testing, Oliva initially refused to voluntarily recall the product and falsely claimed he did not use the implicated lot of Sienna Leaves Powder in the production of dietary supplements, DOJ alleged. The product was only voluntarily recalled after FDA issued a safety alert, DOJ added.
FDA returned to Salud’s facility in May 2021, revealing the supplements manufactured and distributed by the defendants are “adulterated” because they fail to meet the cGMPs, the lawsuit alleged. On March 7, Judge Edmond E. Chang of the Northern District of Illinois entered the consent decree against Salud, Olivia, production manager Michel Monfort and QC manager Carolina L. Giral.
Defendants are liable to the U.S. government for $2,500 in liquidated damages for each day the consent decree, the FDCA or its implementing regulations is violated by any of them, as well as $2,500 in liquidated damages per day per violation. They also are liable for "an additional sum in liquidated damages equal to twice the retail value of any product distributed in violation of" the consent decree, the FDCA or its implementing regulations.
Jeffrey Strange, a lawyer listed as representing the defendants in the consent decree, did not immediately respond Tuesday to an emailed request for comment from Natural Products Insider.
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