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.

FTC settles final charges against supplement sellers

The final three of nine defendants that marketed joint health and a cognitive health supplements have agreed to settle allegations brought by the Federal Trade Commission (FTC) and Maine that they engaged in misrepresentations in promoting the products, the FTC announced. The defendants were charged with violating the FTC Act, the Electronic Fund Transfer Act and its implementing Regulation E, the Telemarketing Sales Rule, and the Maine Unfair Trade Practices Act. Synergixx, LLC, an ad agency, and two individuals including the company’s principal, are barred from engaging in a wide range of marketing practices and ordered to pay a $6.5 million monetary judgment that is suspended based on their inability to pay. The settlement orders are similar to the orders against the other defendants, which the FTC announced in February.

The FTC and Maine charged nine defendants with making false and misleading claims that purported cognitive health supplement CogniPrin: (1) reversed mental decline by 12 years; (2) improved memory by 44 percent; and (3) improved memory in as little as three weeks and is clinically proven to improve memory; and that purported cognitive health supplement FlexiPrin: (1) reduced joint and back pain, inflammation, and stiffness in as little as two hours; (2) rebuilt damaged joints and cartilage and; (3) had been clinically proven to reduce the need for medication in 80 percent of users and to reduce morning joint stiffness in all users.

Synergixx and Fusco advertised CogniPrin and FlexiPrin through 30-minute radio spots that were formatted to sound like educational talk shows, and created inbound call scripts that allegedly deceptively claimed that consumers could try the supplements “risk-free” with an unconditional 90-day money-back guarantee, without disclosing that consumers would have to enroll in an auto-ship continuity plan to qualify for the “risk-free” trial offer, and would have 14 days or less to try the products. The FTC also charged Synergixx and its principal with failing to make important disclosures when they “up-sold” consumers negative option buying clubs and discount medical programs with ongoing fees, charging many consumers for poorly disclosed auto-ship continuity plans they did not want.

One individual, whom defendants presented as an objective medical expert, was charged with providing endorsements without examining the products or exercising his represented expertise. Synergixx and its principal allegedly failed to disclose that he was paid a percentage of FlexiPrin and CogniPrin sales revenues.

The two orders against Synergixx and its principal and the medical expert bar the defendants from making the false or unsubstantiated health claims challenged in the complaint, require them to have competent and reliable scientific evidence when making health-related claims, and require them to clearly disclose their material connections between product sellers and product endorsers. Also, the defendants are barred from misrepresenting the existence or outcome of tests and studies when they promote health products. Additionally, Synergixx and its principal are barred from employing deceptive marketing practices relating to cancellations, negative-option payment plans, upsold merchandise, and deceptive pricing practices.

Lunada settlement settlement halts false marketing of Amberen®

Lunada Biomedical, Inc., and its principals (Lunada, collectively) agreed to settle charges by the Federal Trade Commission (FTC) that it deceptively marketed Amberen®, a dietary supplement, to perimenopausal and menopausal women over 40 by making a range of unsupported claims about the drug’s ability to aid in weight loss and relieve menopause-related symptoms. The proposed stipulated order prohibits Lunada from making unsubstantiated efficacy or health benefit claims for any dietary supplement, food, or drug or conducting any other illegal activities related to consumer satisfaction claims, “risk-free trial” offers, and consumer endorsements. Lunada will pay $250,000 of a $40 million judgment, based on its inability to pay the full amount.

Allegations

The FTC filed a complaint in May 2015 and amended it in December 2015. The amended complaint alleges that Lunada made unsubstantiated claims that Amberen causes substantial and sustained weight loss, loss of belly fat, and an increase in metabolism in women over 40 who are perimenopausal or menopausal and that it is clinically proven to cause substantial and sustained weight loss in such women. The FTC also alleged that Lunada made unsubstantiated claims that the drug was clinically proven to alleviate nearly all common symptoms of menopause, including hot flashes, night sweats, sleep problems, fatigue, and irritability. According to the FTC, a 2001 clinical trial by the scientists who developed the formula used a double dose of Amberen and did not specifically measure weight loss. A subsequent clinical study failed to show a statistically significant difference in the weight lost by control group and test group participants.

In addition to making unsubstantiated claims, the FTC alleged that Lunada failed to disclose its relationship with certain consumer endorsers and made false claims of consumer satisfaction and success rates of nearly 93 percent. It also falsely told consumers they could try Amberen “risk-free” for 30 days. In fact, instead of receiving a 30-day supply, consumers were given a 90-day supply of the product and, to qualify for a refund, were required to return two unopened product boxes at their own expense within 30 days of placing the order.

Settlement Terms

The proposed stipulated order bars Lunada from:

  • claiming that any dietary supplement, food, or drug causes weight loss, sustained weight loss, or loss of belly fat; boosts metabolism; relieves hot flashes, night sweats, and other specific symptoms of menopause; or cures, mitigates, or treats any disease, unless they have human clinical testing that meets certain requirements and is sufficient to substantiate that the claims are true;
  • making any misleading or unsubstantiated claim about the health benefits or efficacy of any dietary supplement, food, or drug;
  • misrepresenting the results of any test of the product;
  • misrepresenting any material fact about the product or any material terms and conditions of any offer for it; and
  • failing to disclose any material connections (such as financial relationships) they have with endorsers.