Dietary Supplements Are Subject to FDA Investigation. GNC Entered Into Agreement with Department of Justice to Keep Potentially Illegal Dietary Supplements Out of the Marketplace.

Nutritional supplements are often recommended or sold by practitioners such as chiropractors, naturopathic doctors and other providers. Determining what ingredients are in the products is difficult and a recent settlement shows that retailers will be held responsible for selling products with misbranded supplements or that promise to treat or cure a disease. 

All providers who sell supplements should ensure that the products do not include unlawful dietary supplements to the extent possible. How can a retailer determine if supplements are from natural plants or are synthetic? 

On December 7, 2016, the world’s largest dietary supplement retailer, GNC Holdings Inc. (GNC), entered into a wide-ranging agreement with the Department of Justice to reform its practices related to potentially unlawful dietary ingredients and dietary supplements, and has further promised to embark on a series of voluntary initiatives designed to improve the quality and purity of dietary supplements.

The non-prosecution agreement resolves GNC’s liability for selling certain dietary supplements produced by a firm currently under indictment.  As part of the agreement, GNC has agreed to pay $2.25 million to the U.S. government and cooperate in dietary supplement investigations conducted by the government.

A lengthy investigation conducted by the U.S. Food and Drug Administration (FDA), the U.S. Attorney’s Office for the Northern District of Texas, and the Consumer Protection Branch of the Department of Justice’s Civil Division resulted in allegations that GNC’s practices related to ensuring the legality of products on its shelves were lacking. 

According to an agreed-upon statement of facts that accompanies the non-prosecution agreement, GNC admitted it engaged in acts and omissions that allowed a misbranded supplement— OxyElite Pro Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs)—to be sold at GNC locations nationwide in 2013.  The statement of facts notes that GNC sold the product based on representations from USP Labs that ingredients contained in the product complied with the law.  It further notes that GNC did not undertake additional testing or require additional certifications to confirm such representations or to verify that the ingredients in the product were as represented. 

USP Labs was indicted in November 2015 and is awaiting trial.  The indictment alleges, among other things, that USP Labs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling, and then lied about the source and nature of those ingredients after it put them in its products.  According to the indictment, USP Labs told some of its retailers and wholesalers that it used natural plant extracts in some of its products, when in fact it was using synthetic stimulants manufactured in a Chinese chemical factory.

Tracy Green Speaking at Business Basics Webinar on "HIPAA for Naturopathic Doctors in a High Tech World"

I am speaking and presenting today for the California Naturopathic Doctors Association. You can register and participate live with questions and answer sessions or you can register and watch later.

This seminar is designed to outline the HIPAA rules for Naturopathic Doctors practicing in the real world. The real world includes office staff that need to be trained and understand these rules since you are responsible for their conduct. Naturopathic doctors also practice in a high tech world with email, cloud storage, flash drives, laptops, and smart phones all containing protected health information. Using actual experiences from the trenches, challenging compliance issues will be used as case examples for everyone to learn from. A list of agreements your practice requires along with sample draft agreements will also be provided.

Attend this presentation to confidently:

• Understand what information must be protected under the HIPAA privacy laws
• Understand the HIPAA patient rights
• Know when patient information can be disclosed (treatment, payment, subpoenas, etc.)
• Understand what agreements you need to establish with employees and business associates
• Understand your role as a healthcare provider in maintaining privacy of protected health information for: patient care, contacting patients,  marketing and social media
• Be aware of consequences for non-compliance
• Know what to do if there is a breach of patient protected health information

Posted by Tracy Green, Attorney at Law

Respiratory Therapist Arrested For Practicing Medicine Without A License For Botox Injections And Representing Himself As Naturopathic Doctor

On June 20, 2013, a licensed respiratory therapist, Santiago Alvarez was arrested as part of an undercover investigation by the Medical Board of California’s Operation Safe Medicine Task Force. The case has been filed in the Riverside County Superior Court by the District Attorney’s Office. Mr. Alvarez has been charged with practicing medicine without a license, along with grand theft by false pretenses. Mr. Alvarez is presumed to be innocent.

It is alleged that Mr. Alvarez owned and operated LogiHealth and Rejuvenix Medical, LLC, both located in Moreno Valley, California. A licensed Respiratory Care Practitioner, he allegedly represented himself as a Naturopathic doctor “Board Certified in Anti-Aging Medicine.” As part of the undercover operation, he allegedly provided Botox injections at both locations, which by law are required to be administered by a licensed physician, or a physician’s assistant, advanced nurse practitioner or registered nurse under direct supervision of a licensed physician. It was further alleged that Mr. Alvarez used the DEA number and forged the signature of another licensed physician to obtain prescriptions.

This case shows that complaints are increasingly being referred for undercover operations. We have seen an increase in undercover agents being sent into clinics being investigated to see if the rules against the unlicensed practice of medicine are being violated.

Posted by Tracy Green, Esq.
Contact: tgreen@greenassoc.com
Green and Associates, Attorneys at Law