Feds Finally Crack Down on Illegal Dietary Supplement Makers

Hardly a week goes by without the Food and Drug Administration (FDA) issuing multiple public warnings about dietary supplements that have been spiked illegally with hidden drug ingredients or contaminated with other potentially dangerous substances. Among the most common examples of such tainted products, which often are sold online, are:

• Supplements marketed for sexual enhancement that contain one or more active ingredients found in prescription drugs used to treat erectile dysfunction, such as sildenafil (VIAGRA) and tadalafil (CIALIS).[1],[2]
• Products promoted for weight loss that have sibutramine, a controlled substance that for years was marketed in the U.S. as a prescription weight loss drug but was withdrawn in 2010 for safety reasons related to an increased risk of heart attacks and strokes.[3]

Other dietary supplements have been found to be contaminated with toxic substances such as lead, mercury and chemicals that can injure the liver.[4],[5] These hidden active drug ingredients or contaminants pose potentially life-threatening health risks to consumers who are unwittingly exposed to them.

For years, companies marketing these dangerous products largely have escaped serious legal consequences because of ineffective enforcement by the FDA, the Federal Trade Commission (FTC) and other federal agencies. But in late 2015, the federal government finally signaled that it may be shifting gears and taking a much more aggressive stance to combat the widespread marketing of illegal dietary supplements.

Criminal indictment

On Nov. 17, the Department of Justice (DOJ), the FDA, the FTC and other federal regulators announced a series of criminal and civil actions against more than 100 companies and individuals that produce or market dietary supplements.[6] In each case, the government alleges that companies were illegally marketing dietary supplements with false labeling or misleading health and disease treatment claims lacking scientific evidence.

In the most dramatic action, the DOJ unsealed an 11-count criminal indictment against USPlabs LLC, a Dallas-based company that had manufactured dietary supplements promoted for workouts and weight loss. Also indicted were several of the company’s corporate officers, including its chief executive officer and president.

The indictment alleges that USPlabs conspired to import from China ingredients for its supplements using falsified documents certifying the content and quality of those ingredients, and then lied about the source and nature of the ingredients after using them to manufacture its products. Furthermore, the company is accused of telling some of its retailers and wholesalers that it used “natural plant extracts” to make some of its most popular supplements, when in fact it was using a synthetic stimulant produced by a Chinese chemical factory.

The most troubling allegations outlined in the indictment involve the USPlabs’ OXYELITE PRO dietary supplement. In October 2013, the FDA and the Centers for Disease Control and Prevention had alerted health care providers and consumers about an outbreak of acute liver injury — and in some cases liver failure — linked to the use of OXYELITE PRO, marketed by the company for weight loss and muscle building.[7],[8] At least two dozen people fell ill after using the supplement.[9] Two required a liver transplant, and one died.[10]

The DOJ indictment alleges that in October 2013, after the liver disease outbreak had been linked to OXYELITE PRO, senior officials at USPlabs informed the FDA that it would stop distributing the product.[11] Instead, USPlabs allegedly engaged in a secretive “all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible.” The product was sold in dietary supplement stores nationwide.

Commenting on the indictment, Howard Sklamberg, an FDA deputy commissioner, said, “The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to bring justice.”

Civil cases

In addition to the criminal indictment against USPlabs, the DOJ also announced on Nov. 17 that it had filed five civil cases against a number of other businesses and individuals for allegedly selling illegal dietary supplements.[12]

For example, in one case, the government alleges that dietary supplement maker Vibrant Life, a Los Angeles-based company, illegally sold several products — including TAHEEBO LIFE TEA, LIFE GLOW PLUS and GERMANIUM — that were promoted as treatments for cancer, Type 2 diabetes, Alzheimer’s disease and HIV infection.[13] These claims by the company meant the supplements were being promoted as unapproved new drugs, an illegal activity. The FDA had warned the company in August 2013 that the promotion of its dietary supplements as cures for disease was illegal. The company promised to remedy the violations but allegedly failed to do so. The government is seeking a permanent restraining order against the company to stop the alleged illegal conduct.

The DOJ filed another civil complaint against Regeneca Worldwide and Matthew A. Nicosia, its chief executive officer, alleging that the company sold adulterated dietary supplements that had not been produced in accordance with FDA-mandated manufacturing standards for ensuring safety and quality.[14],[15] The company also allegedly sold a dietary supplement called REGENESLIM APPETITE CONTROL that contained the chemical dimethylamylamine (DMAA) without listing that ingredient on the product’s label. The FDA has declared DMAA an unsafe food additive not to be used in dietary supplements.

One-time spike or permanent change?

The criminal and civil actions announced by the government in November 2015 were the culmination of a yearlong effort by federal regulators to focus enforcement resources on a segment of the dietary supplement market that has raised increasing public health concerns across the U.S.

Commenting on these actions in a press release, Principal Deputy Assistant Attorney General Benjamin Mizer said, “The Justice Department and its federal partners have joined forces to [bring] to justice companies and individuals who profit from products that threaten consumer health. The USPlabs case and others brought as part of this sweep illustrate alarming practices the department found — practices that must be brought to the public’s attention so consumers know the serious health risks of untested products.”

These DOJ charges against numerous marketers of illegal dietary supplements are a welcome sign. However, the federal government must sustain its new aggressive enforcement stance in overseeing the dietary supplement industry. Otherwise, other unscrupulous companies and individuals will gladly seek to make a quick buck by selling dangerous supplements to unsuspecting consumers.

References

[1] Food and Drug Administration. Public notification: Super Dragon 6000 capsules contain hidden drug ingredient. October 23, 2015.http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Me dicationHealthFraud/ucm469079.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 18, 2015.

[2] Food and Drug Administration. Public Notification: Wild Sexx capsules contain hidden drug ingredients. October 23, 2015.http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Me dicationHealthFraud/ucm469085.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 18, 2015.

[3] Food and Drug Administration. Public Notification: Tip-Top Shape contains hidden drug ingredient. October 23, 2015.http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Me dicationHealthFraud/ucm468945.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 18, 2015.

[4] Food and Drug Administration. FDA consumer advice on Shree Baidyanath brand ayurvedic dietary supplements. Updated September 18, 2015.http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm463159.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 18, 2015.

[5] Food and Drug Administration. OxyElite Pro: Health advisory — acute hepatitis illness cases linked to product use. October 8, 2013.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370857.htm. Accessed November 20, 2015.

[6] Department of Justice. Justice Department and federal partners announce enforcement actions of dietary supplement cases: Criminal charges brought against bestselling supplement manufacturer. November 17, 2105. http://www.justice.gov/opa/pr/justice-department-and-federal-partners- announce-enforcement-actions-dietary-supplement-cases. Accessed November 20, 2015.

[7] Food and Drug Administration. OxyElite Pro: Health advisory — acute hepatitis illness cases linked to product use. October 8, 2013.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370857.htm. Accessed November 20, 2015.

[8] Centers for Disease Control and Prevention. Acute hepatitis and liver failure following the use of a dietary supplement intended for weight loss or muscle building. October 8, 2013.http://emergency.cdc.gov/HAN/han00356.asp. Accessed November 19, 2015.

[9] Food and Drug Administration. OxyElite Pro: Health advisory — acute hepatitis illness cases linked to product use. October 8, 2013.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370857.htm. Accessed November 20, 2015.

[10] Ibid.

[11] Department of Justice. Justice Department and federal partners announce enforcement actions of dietary supplement cases: Criminal charges brought against bestselling supplement manufacturer. November 17, 2015. http://www.justice.gov/opa/pr/justice-department-and-federal-partners- announce-enforcement-actions-dietary-supplement-cases. Accessed November 20, 2015.

[12] Ibid.

[13] Case No.: 2:15-cv-8889. Filed November 16, 2015.http://www.justice.gov/opa/file/793676/download. Accessed November 20, 2015.

[14] Department of Justice. Justice Department and federal partners announce enforcement actions of dietary supplement cases: Criminal charges brought against bestselling supplement manufacturer. November 17, 2105. http://www.justice.gov/opa/pr/justice-department-and-federal-partners- announce-enforcement-actions-dietary-supplement-cases. Accessed November 20, 2015.

[15] Case No.: 8:15-cv-1893. Filed November 16, 2015.http://www.justice.gov/opa/file/793686/download. Accessed November 20, 2015.