Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Nov. 18, 2022
A doctor licensed in Virginia, Maryland, and elsewhere was sentenced today to 3 years for writing and referring compounded drug prescriptions in return for illegal kickback payments. The doctor previously entered into a civil settlement with the Government that requires him and the company he owned to pay $3.1 million.
Nov. 23, 2022
A licensed Orange County pharmacist has been found guilty by a jury of nearly two dozen federal criminal charges for her role in a health care fraud scheme in which more than 1,000 bogus prescriptions for compounded medications were filled, costing Tricare, the U.S. military's health care plan, more than $11 million in losses, the Justice Department announced today.
FOR IMMEDIATE RELEASE
NEWARK, N.J. – Two owners of a New Jersey pharmaceutical marketing company admitted their roles in a $38 million compounded medication health care fraud scheme, U.S. Attorney Philip R. Sellinger announced.
Samantha Zaretzky, 42, of Wayne, New Jersey, and Lee Nichols, 43, of Fair Haven, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to separate informations charging each with one count of conspiracy to commit health care fraud.
According to documents filed in this case and statements made in court:
Through their company, Synergy Medical LLC, Zaretzky and Nichols exploited the manner in which health insurance plans processed, screened, and paid for customized drugs known as “compounded medications,” causing tens of millions of dollars of losses to several health insurance plans over two years. Zaretzky and Nichols pocketed millions of dollars through this compounding fraud scheme.
Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a medical professional determines that an FDA-approved medication does not meet the health needs of a particular patient.
From April 2014 to June 2016, Zaretzky and Nichols used Synergy as a platform through which they could market prescription-based compounded medications without regard to whether a health insurance beneficiary actually needed such a medication or whether an FDA-approved medication would have been appropriate and sufficient.
Zaretzky and Nichols and their conspirators determined which combination of compounded ingredients was most financially lucrative. Through their sales representatives, they recruited health insurance beneficiaries who were willing to obtain these expensive, but medically unnecessary, compounded medications before a medical professional had evaluated the beneficiaries’ unique and individualized need for the medications. After convincing the beneficiaries to obtain a pre-formulated compounded medication, in many cases, Zaretzky, Nichols, and their sales representatives steered beneficiaries to a medical professional with whom the beneficiaries had no prior doctor-patient relationship, such as a telemedicine company. Although the beneficiaries did not have a prior relationship with the telemedicine doctors, Zaretzky and Nichols paid that company for consulting with the beneficiaries. On at least one occasion, Zaretzky and Nichols paid an advanced practice nurse, whose license was inactive, to write prescriptions in exchange for cash. Once those medical professionals issued the prescriptions, Zaretzky and Nichols ensured that the prescriptions were steered to compounding pharmacies that paid them a kickback.
The health care fraud conspiracy charge carries a statutory maximum prison sentence of 10 years and a fine of $250,000 or twice the gross gain or loss from the scheme, whichever is greatest. Sentencing is scheduled for April 23, 2023.
U.S. Attorney Sellinger credited special agents and an analyst of the FBI, under the direction of Special Agent in Charge James E. Dennehy in Newark, and Defense Criminal Investigative Service, under the direction of Special Agent in Charge Patrick J. Hegarty, with the investigation leading to today’s guilty pleas.
The government is represented by Assistant U.S. Attorney George L. Brandley of the Health Care Fraud Unit in Newark.
| Jayde's Vapor Lounge | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Vapor Plus OK LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| "David M. Lubeck, M.D./Arbor Centers for EyeCare | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) | ||||
| Jam Jam Services, Inc. | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| La Serranita Import and Export LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| J R Imports LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Shuzy Rock Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
November 21, 2022
Today, the U.S. Food and Drug Administration (FDA) posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).
Warning letters were sent to the following companies:
These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.
The use of CBD raises safety concerns, especially with long-term use. Risks include liver injury, harm to the male reproductive system, and side effects, such as changes in alertness and other symptoms. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.
FDA experts commented on the agency’s concerns with adding CBD to food and on information they want consumers to know. View the conversation on our website.
Today’s warning letters also outline additional violations of the FD&C Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.
Today, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
The warning letters were issued to: Essential Elements (Scale Media Inc.); Calroy Health Sciences LLC; Iwi; BergaMet North America LLC; Healthy Trends Worldwide LLC (Golden After 50); Chambers' Apothecary; and Anabolic Laboratories, LLC.
“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”
Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
| EC Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| HolleHippos LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Cali Steam, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Lucero Produce II Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| One Stop VAPE Shop #3 - Grove | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Today, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products.
The unauthorized products described in the warning letters include e-cigarettes that:
"The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”
The FDA issued warning letters to:
The warning letters notify the recipients that e-cigarettes without a marketing authorization order are adulterated and misbranded, and that selling or distributing these products to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition, products that appear to be misbranded or adulterated that are offered for import into the U.S. are at risk of being detained or refused admission. Retailers and distributors should communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
“The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said Dr. King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.”
Today’s warning letters mark another step in the FDA’s continued efforts to remove illegally marketed tobacco products from the market. Through Oct. 28, the FDA has issued more than 440 warning letters to firms marketing illegal e-cigarettes containing tobacco-derived nicotine, and more than 60 warning letters to firms marketing illegal products containing non-tobacco nicotine. On Oct. 18, the U.S. Department of Justice (DOJ), on behalf of the FDA, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers who failed to submit premarket applications for their e-cigarette products and continued to illegally manufacture, sell, and distribute their products, despite previous warnings from the FDA that they were in violation of the law.
FDA is notifying consumers of a product promoted for sexual enhancement that has been found to contain a hidden ingredient and might pose a significant health risk: Sangter Natural Male Energy Supplement contains hidden drug ingredient.
Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.