United States Files Enforcement Action Against Long Island Company and Its Owner to Prevent Distribution of Adulterated and Misbranded Dietary Supplements

BROOKLYN, N.Y. – The United States filed a civil complaint against Riddhi USA Inc. of Ronkonkoma, New York, and its owner and President Mohd M. Alam to prevent the distribution of adulterated and misbranded dietary supplements in violation of federal law, the Department of Justice announced today.
 

The complaint, filed in the U.S. District Court for the Eastern District of New York, alleges that dietary supplements that the defendants manufactured, prepared, packed, repacked, labeled, held and distributed were adulterated and misbranded.  The complaint further alleges that these dietary supplements were prepared, packed, and held under conditions that do not comply with current good manufacturing practice regulations for these types of products.
 

The Department filed the complaint at the request of the U.S. Food and Drug Administration (FDA).

“Dietary supplement manufacturers that do not comply with applicable laws and regulations designed to protect consumers put those consumers at risk,” said Acting U.S. Attorney Bridget M. Rohde of the Eastern District of New York. “Today’s action demonstrates the Department’s commitment to safeguarding the public from adulterated and misbranded products.”

 “The Department of Justice is committed to ensuring that dietary supplement manufacturers comply with laws designed to protect consumers,” said Acting Assistant Attorney General Chad A. Readler, head of the Justice Department’s Civil Division.  “The Department of Justice will continue to work with the FDA to protect the public from adulterated and misbranded products, and to ensure that dietary supplement manufacturers provide accurate information about what is in their products.”
 

According to the complaint, the FDA inspected the defendants’ facility in January 2017 and found numerous significant deviations from current good manufacturing practice regulations.  For example, as alleged in the complaint, the defendants failed to establish product specifications for identity, purity, strength, and composition of their finished dietary supplements, failed to conduct at least one appropriate test to verify the identity of a dietary ingredient, and failed to establish and follow written procedures for quality control operations.
 

  The complaint further alleges that many of the current good manufacturing practice deviations observed during the FDA’s January 2017 inspection were the same or similar to those observed by the FDA during a previous inspection of the defendants’ facility that occurred in January 2016.  The complaint noted that following the January 2016 inspection, the FDA issued a warning letter to the defendants detailing violations of current good manufacturing practice regulations observed during the 2016 inspection.  The complaint alleges that the current good manufacturing practice violations noted in the warning letter were the same as or similar to those observed during the FDA’s subsequent 2017 inspection.
 

The complaint also alleges that the defendants misbranded their dietary supplements by failing to comply with the relevant labeling provisions of the federal Food, Drug, and Cosmetic Act.  For example, as noted in the complaint, the defendants’ products are fabricated from two or more ingredients but fail to declare any ingredients on their product labels or labeling.  Food, including dietary supplements, is also misbranded if its label or labeling fails to declare the major food allergen “soy” as defined in the law.  The complaint alleges that the defendants’ Neuroxygen dietary supplement product is misbranded because it is manufactured using soy lecithin, which contains “soy,” but the defendants fail to list soy on the product label.  Some of the defendants’ dietary supplement labels or labeling, including its labels or labeling for its Prenatal Formula, Osteo Gest, Neuroxygen, Inflam-Ease, and Aller-Ease products, fail to declare the place of business of the manufacturer, packer, or distributor as required by law.

The government is represented by Trial Attorney Monica Groat of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Edwin Cortes of the U.S. Attorney’s Office for the Eastern District of New York, with the assistance of Associate Chief Counsel for Enforcement Roselle Oberstein of the FDA, Office of General Counsel, Department of Health and Human Services.
 

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
 

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of New York, visit its website at https://www.justice.gov/usao-edny.