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Federal judge orders Flawless Beauty to stop distributing unapproved drugs
A federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.
U.S. District Judge Peter G. Sheridan entered a consent decree of permanent injunction today between the United States and Flawless Beauty LLC of Ocean Township and Asbury Park, New Jersey, the company’s co-owners, Jack H. Gindi and Susana B. Boleche, and an affiliated company owned by Mr. Gindi, RDG Imports LLC.
According to the complaint for permanent injunction, which the U.S. Department of Justice filed on the FDA’s behalf, Flawless Beauty sold unapproved and improperly labeled (misbranded) drugs which present serious public health risks, particularly purportedly sterile injectable skin whitening drug products. Intravenous and intramuscular administration of these unapproved drugs, for which sterility cannot be assured, could result in serious health risks. These risks include nerve or blood vessel damage, infection or toxic systemic reactions. The company also sold several products that are labeled to contain human placenta, which can result in serious illness.
Some of the products sold by Flawless Beauty also implied FDA approval or endorsement, which the company did not have.
“Despite repeated warnings, Flawless Beauty continued to put patients at risk by selling potentially dangerous and unproven treatments to consumers,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge consumers to beware of these and other unproven drug products that use deceptive marketing tactics to sell their unsafe products.”
The consent decree prohibits Flawless Beauty, RDG Imports and its owners from directly or indirectly importing, manufacturing and/or distributing any drug products until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Under the consent decree, the company has 20 days to recall all ampules or lyophilized vials, including those sold as part of whitening kits, and all injectable products. These include products sold under the Relumins, Tatiomax, TP Drug Laboratories, Laennec, Saluta, Tationil and Laroscorbine brands, among others.
Additionally, under the consent decree, Flawless Beauty, RDG Imports and its owners must also hire an expert to review their drug products and receive written permission from the FDA before they can resume distributing drugs. The company and its owners will be assessed monetary damages if they fail to meet any of the terms of the consent decree, the FD&C Act or applicable regulations.
Federal law requires a new drug to undergo the FDA drug approval process to be legally marketed in the United States. The drug approval system is designed to prevent patients from being exposed to the risks associated with potentially unsafe, ineffective and poor quality drugs. The FDA has not approved any injectable drugs for skin whitening or lightening.
In September 2014, U.S. Marshals seized various unapproved and improperly labeled drug products sold and distributed by Flawless Beauty at the request of the FDA, including numerous injectable skin whitening products such as the Relumins Advanced Glutathione kits and Tatiomax Glutathione Collagen Whitening kits. Despite this seizure action, the company and its owners continued marketing and distributing unapproved drugs, which prompted federal authorities to seek further enforcement action.
The FDA urges health care professionals and consumers to report any adverse events related to products sold by Flawless Beauty to its MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch online voluntary reporting form; or
- Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Author: Bác sĩ Da liễu Hun Kim Thảo
Grace Skincare Clinic
An international cosmetic dermatology clinic in Vietnam using FDA and CE-approved medical devices and treatments.
Mayfair Suites, 102ABC Cong Quynh, District 1, Ho Chi Minh city, Viet Nam
Book your appointment: https://www.graceskinclinic.com/book-now
Tel: 0822-531-223
Hotline: 0961796809
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Từ sau khi đến Grace Skincare Clinic da mình khoẻ lên hẳn, tình trạng mụn đở hẳn đi, từ bác sĩ cho đến nhân viên đều rất chuyên nghiệp và phục vụ rất tận tình. Dịch vụ chăm sóc Kh rất tốt, mình cảm thấy rất hài lòng khi lựa chọn dịch vụ của Grace Skin.
Trước khi quyết định làm gì đó, mình tìm hiểu rất nhiều. Mình là người khó tính nhưng Grace Skincare Clinic đã thuyết phục được mình. Bác sĩ Thảo rất tận tâm, thăm khám kỹ, dặn dò rất cẩn thận. Nhân viên bạn nào cũng nhiệt tình, dễ thương. Máy móc hiện đại. Và 2 điều mình đánh giá cao đó là HIỆU QUẢ và DỊCH VỤ BẢO HÀNH.
0-09-2019 "I would love to thank Dr. Hun Kim Thao and her amazing staffs for helping me through a skin improving journey over an almost year while I was staying in HCM. I received acne facial and peel every other week and the service was superb! Each procedure was well explained and Dr.Thao was very attentive. I loved her holistic way of approach to improve patient's skin. Not only she prescribed very effective acne gel but also shared great tips such as reducing the amount of simple carb intake, cutting down sugar, and most importantly highlighting the importance of getting enough sleep. She even recommended a well known doctor in town who could help me with my sleeping problem. In addition, the price was very reasonable and I was very happy with all the service I got from Grace Skin Clinic. Oh Dr. Thao even asked her staff to make me a cup of tea one day as she she thought I looked overly exhausted. I was very moved. How warm hearted she is! I will definitely recommend this place to anyone who wants to check up their skin and improve their skin. Amazing place!"
This place is amazing; they help me improve my terrible skin condition which had affected my identity, and my confidence for many years. I have been visiting Grace Clinic during summer time for the past two years, and every time I am here, they create a different program in order to fit my skin condition and my limited time. Furthermore, people from Grace Clinic always greet me with warm hearts. They once invited me to have boba tea with them which made me no longer feel like a customer but a friend which it has created a friendship overtime. I cannot stress how highly I would recommend this place. Again, they are amazing and very professional. There is one thing, you can do walk-in just fine but it would be better if you schedule the appointment so they can prepare and create the best service for you.
I absolutely love the ladies of Grace Skincare. I was staying in Saigon for 6 months and came here with acne and a congested skin from my travels. So happy I found them! Their prices are reasonable compared to other “expat” clinic that I went to. I bought the 10 facial package for a really good price and am really happy with the result of my skin after following all of their consultations. Acne has cleared up and now we’re focusing on my other skin concerns such as dark spots and hyperpigmentation. I highly recommend this clinic. They truly want you to walk out with skin you feel confident in. I’m going to miss this place and the ladies I got to connect with during my time here. Amazing results · Expert facials · Great deals · Professional products ·Licensed skin care professional · Experienced skin care professionals
Hey guys it’s been 3 weeks since we came for our treatment. I can honestly say it’s the best I have had done. Andrew and I look fresh without being overdone. We both had people say how refreshed we look after our holiday. Honestly they wouldn’t be saying that if they knew how much beer and yummy Vietnamese food we consumed when we were there. I can honestly say Andrew and I will be back. And I am telling all my friends how fantastic you guys are and how professional the consultation was. I have yet to find someone in Australia who is so thorough. Thank you, Kylie
I had a acne treatment here last month and now it's improved a lot. I must say that this place is very professional, modern equipment, especially the thoughtful doctor! I'm impressed!
Grace Skincare Clinic has a great and friendly service and that have a centrally located clinic. I highly recommend them!
The owners are wonderful people. I had a good experience and can sincerely and highly recommend everything about Grace Skincare Clinic!
I was so embarrassed with the scars and pigmentation marks on my face. These are from old sports injuries and harsh products on my legs from childhood accidents. I am fed up with using so much concealer makeup on my face and am never able to wear a skirt with confidence. I heard about the Grace Skincare Clinic pigmentation lightening treatment from a friend. I took 6 treatments & used skincare product as Dr. Thao instructed and now my skin is beautiful and permanently clear. It was worth every penny.
as Tet is coming, I highly recommend this place for a weekend retreat, skin detoxing or even an urgent package to soothe and smooth your skin. I got back my healthy skin after just 02 week following the instruction of Dr Thao Hun and it cost me 200,000 for medical consultation fee only. Wonderful!