New York dietary supplement maker accused of failing to comply with cGMP regulations

At the request of the FDA, the U.S. Department of Justice filed a civil complaint against Riddhi USA Inc. of Ronkonkoma, New York, and its owner and President Mohd M. Alam, to enjoin the distribution of adulterated and misbranded dietary supplements. The complaint alleges that Riddhi and Alam prepared, packed, and held dietary supplements under conditions that failed to comply with the FDA’s current good manufacturing practice (cGMP) regulations for these products.

According to the complaint, the FDA inspected the Riddhi facility in January 2017 and found numerous significant deviations from cGMP regulations, including a failure to: (1) establish product specifications for identity, purity, strength, and composition of their finished dietary supplements; (2) conduct at least one appropriate test to verify the identity of a dietary ingredient; and (3) establish and follow written procedures for quality control operations.

The complaint further alleges that many of the cGMP deviations were the same as those observed by the FDA during a previous inspection that occurred in January 2016. The complaint notes that on April 27, 2016, the FDA issued a warning letter detailing violations of cGMP regulations observed during the 2016 inspection and that these violations are the same as those observed during the FDA’s subsequent 2017 inspection.

The complaint also alleges that the dietary supplements were misbranded under the labeling provisions of the federal Food, Drug & Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) because the products are fabricated from two or more ingredients but fail to declare any ingredients on their product labels or labeling. Specifically, the complaint alleges that the dietary supplement Neuroxygen is misbranded because it is manufactured using soy lecithin, which contains “soy,” but soy is not listed on the product label. The complaint also alleges that the products Prenatal Formula, Osteo Gest, Neuroxygen, Inflam-Ease, and All-Ease, are misbranded because their label or labeling fails to declare the place of business of the manufacturer, packer, or distributor.

$9.8M in refunds for consumers purchasing ‘fat burning’ health products

Almost a quarter of a million refund checks totaling more than $9.8 million will be issued to consumers who purchased “fat burning” and “weight loss” products and other dietary supplements, DVDs, or skin creams, including Pure Green Coffee Bean Plus and RKG Extreme, from Health Formulas LLC and related companies. The Federal Trade Commission (FTC) noted that the average refund per consumer will be $43.

According to the FTC’s original complaint, Health Formulas LLC, its owners, and its related companies, including Simple Pure Nutrition, advertised their products using fake “free trials,” tricked people into disclosing credit and debit card information, and then enrolled them without their permission in a costly negative-option membership program that charged them monthly for new shipments.

A subsequent court order in 2016 settled the FTC’s charges by permanently banning Health Formulas and the other 41 related companies from advertising or selling weight-loss supplements and negative option sales plans, and prohibited them from making unsupported health claims for other products, debiting people’s bank accounts without their consent, and calling consumers who asked not to be called again. It also required them to turn over approximately $10 million in assets.

GNC agrees to reform and pays $2.25M over illegal supplements

GNC Holdings Inc. (GNC), the world’s largest dietary supplement retailer, agreed to pay $2.25 million under a non-prosecution agreement to resolves the retailer’s liability for selling dietary supplements produced by a firm under indictment. GNC also agreed to reform its practices related to potentially unlawful dietary ingredients and pledged to undertake voluntary initiatives designed to improve the quality and purity of dietary supplements.

Investigation

The FDA, the U.S. Attorney’s Office for the Northern District of Texas, and the Consumer Protection Branch of the Department of Justice’s (DOJ’s) Civil Division conducted an investigation which revealed the inadequacy of GNC’s practices regarding the legality of the products on its shelves. The investigation found, in 2013, GNC sold, nationwide, OxyElite Pro™ Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs). GNC sold the product based upon representations from USP Labs that the product and its ingredients complied with the law. However, GNC did not undertake additional testing or require additional certifications to confirm those representations.

USP Labs

In 2015, USP Labs was indicted and is currently awaiting trial. The indictment alleges that USP Labs conspired to import ingredients from China using false certificates of analysis and false labeling. USP Labs subsequently lied about the source and nature of those ingredients after it put them in its products. Additionally, the indictment alleges that USP Labs told retailers it used natural plant extracts in some of its products, when, in fact, it was using synthetic stimulants manufactured in a Chinese chemical factory.

Agreement

Under GNC’s non-prosecution agreement, the retailer has agreed to:

  • Immediately suspend the sale of a product upon learning that the FDA has issued a public written notice that a purported dietary supplement or an ingredient contained in a purported dietary supplement is not legal and/or not safe;
  • establish two lists—a “restricted list” containing ingredients that are not to be used in dietary supplements and a “positive list” containing ingredients that are approved for sale;
  • substantially revise its internal approach to dealing with the vendors whose products GNC sells, including requiring more explicit guarantees from its vendors that their products do not contain ingredients on the “restricted list”;
  • voluntarily work to develop an industry-wide quality seal program; and
  • update its adverse event reporting policy to ensure that its employees understand the proper procedures to employ if a customer complains of injuries associated with a dietary supplement bought at GNC.