The action, filed as a civil complaint by the Department of Justice in the US District Court for the Eastern District of New York, alleges that the supplement firm Riddhi USA Inc and its owner and president Mohd M. Alam, engaged in the distribution of dietary supplements that 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.
“Dietary supplement manufacturers that do not comply with applicable laws and regulations designed to protect consumers put those consumers at risk,” said Acting US 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 company, which is based in the Long Island suburb of Ronkonkoma, failed repeated inspections. The company received a warning letter in April 2016 relating to an inspection that stretched from Dec. 22, 2015 to Jan. 5, 2016. That letter noted numerous violations, including lack of specifications, lack of written quality control procedures failure to conduct identity tests on ingredients used in the company’s products, deficiencies in master manufacturing records and batch production records and labeling violations that included failure to include a list of ingredients on the labels.
According to the complaint, the FDA inspected the defendants’ facility in again in January 2017 and found numerous significant deviations from current good manufacturing practice regulations. The complaint further alleges that many of the current good manufacturing practice deviations observed during the January 2017 inspection were the same or similar to those observed by the FDA during a previous inspection of the defendants’ facility that ended in January 2016. The complaint alleges that the company made no progress in correcting the deficiencies noted in the warning letter.
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.
Among the labeling violations is one that is a particular health concern. The company used soy lecithin in one of its products for which no ingredients were on the label, thus failing to declare soy as an allergen. While the incidence of soy allergy among the general population is not fully known (one study puts it at 2%), soy is nevertheless one of the major allergens identified by FDA. New rules under FSMA will place additional requirements on dietray supplement firms with regard to allergens, a topic that will be taken up in a future NutraIngredients-USA article.