To Independent Distributors of Hsin Ten Enterprise USA, Inc :
Hsin Ten Enterprise USA, Inc. distributes machine products that are classified as medical devices under the laws and regulations administered by the Food and Drug Administration. The FDA has very strict guidelines we must follow in regards to medical claims and marketing language used.
One of the regulations is Section 502(a) of the Food, Drug, and Cosmetic Act which declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. An unsubstantiated claim of therapeutic value is an example of false statement. Therefore, the following claims are NOT allowed and should be avoided:
• Disease, medical or therapeutic claims • False or misleading claims
Some distributors’ activities and websites may have violated the FDA regulations. Please note that any product testimonials that directly or indirectly lead to medical claims are prohibited. Therefore, we urge you review your independent distributor website(s) immediately.
This letter serves as an official notice to you that it is your obligation to comply with the FDA laws. It is for your own protection as well as for the smooth operation of the company. Hsin Ten Enterprise USA, Inc., requires you review your independent distributor website(s) and make necessary changes in order to comply with the FDA laws; otherwise, it may cause Hsin Ten Enterprise, USA, Inc. to take strict actions including suspending your distributorship.
Thank you for your attention to this matter.