District Court Orders Tennessee Companies and Their Owner to Stop Distributing Unapproved New Drugs and Misbranded and Adulterated Dietary Supplements
A federal court entered a consent decree of permanent injunction against defendants Basic Reset and Biogenyx, as well as their owner, Fred R. Kaufman III, and Kimberly Kaufman, the Department of Justice announced today. The permanent injunction enjoins the defendants from distributing unapproved new drugs and misbranded and adulterated dietary supplements, and a misbranded and adulterated device in violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).
The Department filed a complaint in the Middle District of Tennessee on Aug. 26, at the request of the U.S. Food and Drug Administration (FDA), alleging, among other things, that defendants unlawfully distributed unapproved new drugs and an adulterated and misbranded device. Defendants market their drugs and device with claims that their products can be used to diagnose, cure, mitigate, treat, or prevent conditions, such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies, and pain. The FDA has not approved Basic Reset’s or Biogenyx’s drugs or device for any use.
“Drug and dietary supplement distributors who do not comply with the law risk endangering consumers,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “We work closely with the FDA in our efforts to enforce the laws that are designed to keep consumers safe.”
“The public has the right to expect that products perform according to claims included in their labeling and that the products are safe for use,” said U.S. Attorney Don Cochran. “FDA regulations exists to safeguard consumers and when those regulations are circumvented we will take whatever action is necessary to protect the public.”
“Americans expect and deserve products that meet appropriate standards for quality. To ensure safe use by consumers, it’s important that companies who sell products adhere to standards set forth by the FD&C Act, including product labeling and quality,” said Acting FDA Commissioner Ned Sharpless, M.D. “Despite previous warnings, Basic Reset and Biogenyx placed consumers at risk by distributing certain products in violation of current good manufacturing practice (CGMP) requirements and products which failed to adequately meet labeling standards. The U.S. Food and Drug Administration remains fully committed to taking enforcement action against companies and owners who place unsuspecting American consumers at risk.”
The complaint also alleges that Basic Reset and Biogenyx misbranded and adulterated dietary supplements. Several of Defendants’ dietary supplements are missing information on their labels required by law. FDA inspections also uncovered numerous violations of the agency’s CGMP regulations for dietary supplements, including failing to establish and follow written procedures to review and investigate product complaints and failing to establish specifications to assure that the products they receive for labeling are adequately identified and consistent with the purchase order. Because Defendants failed to follow CGMP regulations, their dietary supplements are adulterated under the FD&C Act.
Basic Reset/Biogenyx is an own label distributor of various drugs, dietary supplements, and a device, and include, but are not limited to, AquaLyte, Bee Gold, Beta Factor, Body Mass Reset, CBD Reset, Dino-Min, Earth Wash, Energy FX, GH-C, Ionyte, Mello-Tonin, Miracle Facelift Masque, Nuovi Firming Masque, Nuovi Skin Toner, pH-FX, Q-min, SlimUp, TrimUp, Vibrant Energy Drink, and Energy FX.
As part of the court-ordered permanent injunction, Basic Reset, Biogenyx, and the other defendants are prohibited from receiving, labeling, holding, or distributing dietary supplements, drugs, or devices at their facility until they, among other things, recall their drugs, dietary supplements, and device, hire qualified experts, and receive written permission from the FDA to resume operations.
The United States is represented by Trial Attorney Charles Biro of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Christopher Sabis of the U.S. Attorney’s Office for the Middle District of Tennessee, with the assistance of Associate Chief Counsel Laura Akowuah of the FDA’s Office of the Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.