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Frequently Asked Questions

Why are these products not FDA approved?

Frequently Asked Questions (FAQ) - Colloidal Silver Colloids
The U. S. Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994 which spells out the regulations as they apply to dietary supplements.
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Frequently Asked Questions
The Federal Drug Administration does not regulate any nutritional supplements. This includes those sold in supermarkets, drugstores, nutrition centers, internet-based businesses, and any place nutritional supplements are sold. However, Biometics products are the rare exception because they are manufactured in a state-of-the-art FDA and OTC approved manufacturing facility that meets the strictest regulations of quality, purity and label content.
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digestive enzymes: food enzyme supplements support nutrition...
We use only the highest quality pharmaceutical grade digestive enzymes. Our products are considered as Dietary Supplements and therefore do not fall under FDA guidelines. As a leader in the health care supplement industry, Enzyme Essentials, Transformation and our manufacturer are committed to enforcing the highest quality control standards. [back to top]
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Is It Approved By The FDA?

Los Angeles Sclerotherapy for Spider Leg Veins
While there are many unapproved substances used to sclerose spider veins, hypertonic saline is the only agent approved by the FDA. Kalologie Skincare uses hypertonic saline for all sclerotherapy treatments.
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Are Mona Vie products FDA approved?

Frequently Asked Questions MV
There is no official approval process or certificate issued by the FDA to approve the sale of any food or juice product. The Food and Drug Administration has established stringent regulations, called Good Manufacturing Practices (GMPs) to ensure the safety and manufacturing of foods sold in the United States. Mona Vie is manufactured in a GMP-compliant facility.
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MonaVie Antioxidant phytonutrient acai juice nutritional dri...
There is no special approval or certificate needed from the FDA to approve the sale of a juice product. As long as the ingredients contained in Mona Vie products are generally recognized as safe, which they are, FDA approval is not necessary.
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Does the FDA have a problem with products? Is it approved?

Herbalife Weight loss and Nutritional FAQ
In 1986 the U.S. Food and Drug Administration thoroughly evaluated our Programs and issued a statement declaring that all of our products were safe. However, the FDA does not actually approve any nutritional product or food supplement, only drugs, medications and medical devices. In addition, whenever our products are introduced into a new country, it is reviewed by that country's government before it is approved for importation and distribution.
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Are Quit For Sure products approved by the FDA?

Learning Center FAQ Stop Smoking Quit Smoking Guaranteed
Quit For Sure products are 100% all-natural herbal solutions to help you quit smoking. According to Food and Drug Administration guidelines, Quit For Sure products are classified as nutritional supplements. Our products are not intended to diagnose, treat, cure, or prevent any disease. These statements have not been evaluated by the FDA.
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Are the products from Whole-istic Solutions FDA approved?

Wholeistic Solutions FAQ
The FDA only approves substances considered to be drugs, not foods. Therefore, FDA approval process is not relevant to Whole-istic Solutions' all-natural products. Nevertheless, every Whole-istic Solutions product is in full compliance with all applicable FDA regulations and all ingredients in Whole-istic Solutions products are in the FDA’s GRAS (Generally Regarded As Safe) category.
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Are TruWell products FDA approved?

Untitled Document
The FDA does not grant approval to Nutraceuticals, only prescription drugs. We are, however, regularly inspected by the FDA and the Texas Department of Health and must adhere to the highest of standards of Good Manufacturing Practices including laboratory analysis and product testing for potency and purity.
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Are IN products approved by the FDA?

Intelligent Nutrients | Product FAQs
IN products do not require approval by the FDA, although individual ingredients may have been reviewed and are recognized as safe for use. All of the product Nutrition Facts are available online at Nutrition Facts.
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Are Symmetry products FDA approved?

Symmetry Health Products Ltd.
The FDA (Food and Drug Administration) regulates food and drugs; Symmetry products are food supplements. The FDA does not approve food supplements. All our ingredients, however, are listed in the FDA's GRAS (Generally Accepted As Safe) list.
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Is Flexcin FDA approved?

Flexcin.com
The Food & Drug Administration does not have an approval process for any nutritional supplements, only perscription medications. However, Flexcin is manufactured in a FDA inspected and approved facility.
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Is decode AF? FDA approved?

deCODE diagnostics
The price of the test is $200, including shipping costs. Payment can be made by any major credit card by the individual or by the ordering physician or clinic, by including the card details on the test request form. Samples submitted anonymously must be accompanied by a valid credit card number from the respective doctor or affiliated health care institution.
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Is this product FDA approved?

Digestive Enzymes for Gas, Bloating, Heartburn, Indigestion,...
Currently, non-prescription nutritional supplements do not require FDA approval. However, BioVitale's Digestive Enzyme Complex is manufactured in a FDA monitored and approved facility under the highest quality control standards.
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Is XanGo Juice approved by the FDA?

XanGo FAQ - Frequently Asked Questions
a dietary supplement, XanGo is considered a food, and does not require FDA approval. The FDA does not offer opinions on or approval of dietary supplements. Independent laboratory testing confirms the safety and purity of all components of XanGo Juice.
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Is Safe Lips FDA approved?

FAQ
The anti-pathogenic and germicidal properties of the silver oxide in Safe Lips has been tested by 14 reputable and independent Contract Research Organizations (CROs). Countless individuals have contacted us with their very positive feedback, declaring the Safe Lips was the major factor in returning them to healthy skin. Furthermore, we have a very liberal return policy where customer satisfaction is 100% guaranteed, and yet we have experienced very few returns.
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When was Herceptin approved by the FDA?

Herceptin Resources Frequently Asked Question
In 1998, Herceptin was approved for the treatment of HER2+ metastatic breast cancer. In 2006, the FDA approved Herceptin for the adjuvant treatment of patients with HER2+, node-positive breast cancer.
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Is this approved by FDA / MHRA (UK) ?

Gourdin - Dr. Pushpa Khanna's List of Research Papers and Pu...
Ans : Since Gourdin is a dietary supplement and NOT a drug, it doesn't necessarily need to be approved by FDA / MHRA (UK). It is used as a health food without a doctor's prescription. We are, however, refining it and working toward applying for FDA / MHRA (UK) approval. We assure you that this in no way reduces the qualities or efficacy of the supplement. We have received a tremedous positive response from our users. And those who still have doubts, we have designed special trial packs for them.
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Is Phazyme® approved/regulated by the FDA?

Frequently Asked Questions
Simethicone, the active ingredient in Phazyme® is the only FDA approved antiflatulent drug. Simethicone meets the OTC Monograph as a safe and effective antiflatulent agent and is regulated as an over the counter drug by the FDA.
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Is Colic-Ease FDA approved?

Colic-Ease Gripe Water
The FDA oversees all food and drug products. Since Colic-Ease is a dietary supplement, it does not fall into either of these categories. However, in 1994 the FDA set up guidelines for dietary supplements, including labeling requirements, and created the Dietary Supplement Health Education Act (DSHEA). Colic-Ease follows all of DSHEA's guidelines.
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Is it FDA approved?

AQuitSmoking.com - Frequently Asked Questions about the Quit...
Yes, most of our users of the Quit Smoking Support System reported that they managed to stop smoking and no longer experienced cravings or withdrawal symptoms. Few smoking cessation products out there can make such similar claims in efficacy, ease, and successfulness.
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Is GHR Platinum FDA approved?

Frequently asked questions on GHR Platinum Growth hormone re...
GHR Platinum is an all-natural supplement and does not fall into the approval jurisdiction of the FDA.
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Is this FDA approved? What kind of research has been done on it?

ECP: FAQ
ECP is approved by the FDA for the treatment of Angina and Congestive Heart Failure. It has undergone rigorous clinical trials at leading universities around the country and ECP has been the subject of scientific studies published in leading medical journals.
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Is Revivol™ FDA approved?

Untitled Document
The US Food and Drug Administration (FDA) does not approve or disapprove of any kind of dietary supplements, such as Revivol ™, since it is not within their responsibility. The FDA only approves or disapproves of pharmaceutical drugs, which Revivol™ is not.
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Is ZymaDerm FDA approved?

Frequently Asked Questions About Molluscum and ZymaDerm
ZymaDerm is 'FDA Compliant' and conforms to the standards of the Homeopathic Pharacopeia of the United States (HPUS), a compendium recognized as both official and authoritative by the FDA. Each of the ingredients in ZymaDerm is stated in the Pharmacopeia to be useful as an aid in the treatment of skin rash conditions. If a drug-free agent is listed in the HPUS for treating certain conditions, a product containing that agent may be marketed for those conditions without specific FDA approval.
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