According to the producers of Biotemper Plus, the product is exhaustive in its working meaning that the root cause of the pain is taking care of permanently. You will not need to keep taking this product.
BIOTEMPER PLUS Review – Is This Product Safe To Use?
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Unapproved New Drug Charges
BIOTEMPER COLD PAIN RELIEF THERAPY
BIOTEMPER COLD PAIN RELIEF THERAPY is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as an external analgesic.
Examples of claims observed on the product label and labeling, which includes the product website www.biotemper.com, that establish the intended uses, as defined in 21 CFR 201.128, of the product include, but may not be limited to, the following:
Statements that appear on the product label:
“FOR ARTHRITIS, SPRAINS, SORE MUSCLES, BRUISES, & BACK PAIN Active Ingredient . . . Menthol 10%”
Statements that appear on the website, www.biotemper.com (i.e., URL imprinted on the product label):
“Many have already experienced the herbal pain relief of Menthol and Arnica, BioTemper combines them to achieve an effective level of pain relief . . . BIOTEMPER is a PAIN RELIEVER that is a fast acting pain relief. It is effective and long lasting for people with Arthritis, Back Pain, Bursitis, Carpal Tunnel, Chronic Pain, Fibromyalgia, Golfer’s Elbow, Heel Pain, Hip Pain, Joint Pain, Muscle Pain, Neck Pain, Nerve Pain, Neuropathy, Plantar Fasciitis, Repetitive Strain Injuries, Sciatica, Severe Migraine and Headache, Shin Splints, Shoulder Pain, Sports Injuries, Tendinitis, Tennis Elbow, and All Other Aches and Pains and General Muscle Pain.”
OTC drug products such as BIOTEMPER COLD PAIN RELIEF THERAPY that are intended for external analgesic indications such as the temporary relief of minor aches and pains of muscles and joints are being evaluated as part of the OTC Drug Review. They have been proposed to be classified as generally recognized as safe and effective and not misbranded under the Tentative Final Monograph (TFM) for External Analgesic Drug Products for Over-the-Counter (OTC) Human Use (48 Federal Register (FR) 5852, February 8, 1983) if they meet each condition in the TFM and each general condition in 21 CFR 330.1.
Pending the promulgation of a final rule, FDA generally does not intend to pursue regulatory action against products marketed in accordance with the conditions proposed in the TFM and each general condition in 21 CFR 330.1. Such marketing, however, is subject to the risk that a final rule may require reformulation and/or relabeling or FDA approval through the “new drug” procedures of the FD&C Act (section 505). However, BIOTEMPER COLD PAIN RELIEF THERAPY does not meet these conditions for the reasons explained below.
The labeling for and formulation of BIOTEMPER COLD PAIN RELIEF THERAPY are not consistent with the condition proposed for external analgesic drug products, see TFM for External Analgesic Drug Products for OTC Human Use (48 FR 5852 at 5868, February 8, 1983). Specifically, the product website identifies arnica as an active ingredient in the product with the following claim, “Many have already experienced the herbal pain relief of Menthol and Arnica, BioTemper combines them to achieve an effective level of pain relief.”
According to 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. The website claims for this specific ingredient demonstrates that arnica is an “active ingredient” as defined in 21 CFR 201.66(b)(2) because the ingredient is intended to furnish pharmacological activity.
Arnica, as an active ingredient, is not included in the OTC Drug Review for external analgesic or any other uses. Further, the external analgesics TFM does not include any claims related to bursitis, carpal tunnel, fibromyalgia, nerve pain, neuropathy, plantar fasciitis, sciatica, severe migraine and headache, and tendonitis; however, all of these indications for use are included in the labeling for BIOTEMPER COLD PAIN RELIEF THERAPY.
Furthermore, we are not aware of any adequate and well controlled clinical trials in the published literature that support a determination that BIOTEMPER COLD PAIN RELIEF THERAPY is generally recognized as safe and effective for its labeled indications. Additionally, we are not aware of a similar OTC drug product that, as formulated and labeled, was available in the United States market on or before the inception of the OTC Drug Review.
Therefore, BIOTEMPER COLD PAIN RELIEF THERAPY is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.
“New drugs” may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. BIOTEMPER COLD PAIN RELIEF THERAPY is not the subject of an FDA-approved new drug application. Therefore, marketing this product in the United States is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d), and violates section 505 of the FD&C Act.
UREA 20, UREA 40, UREA 40+, bare20, bare40, bare40+Salicylic Acid, and bare40+Hyaluronic Acid
UREA 20, bare20, UREA 40, UREA 40+, bare40, bare40+Salicylic Acid, and bare40+Hyaluronic Acid are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.
Specifically, UREA 20, UREA 40, and UREA 40+ are intended as corn and callus remover products, and bare20, bare40, bare40+Salicylic Acid, and bare40+Hyaluronic Acid are intended as combination antifungal/corn and callus remover products.