Source: https://unapprovedpharmacy.com/2010/11/27/fda-warning-evenbetternow/
Timestamp: 2020-01-20 14:23:34
Document Index: 449725969

Matched Legal Cases: ['§ 321', '§ 321', '§ 321', '§ 321', '§ 331', '§ 352', '§ 201', '§ 331']

FDA Warning – Evenbetternow – scamFRAUDalert®Pharmacies Checker
FDA Warning – Evenbetternow
This letter concerns your firm’s marketing of several products, including but not limited to, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and Heavy Metal Screen Test on your websites:
www.evenbetterhealth.com
www.claybathsforkids.com
www.ic-help.com
www.theautoimmunesite.com
These (and other) products are marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
According to the products’ labeling, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, and Natur-Leaf are intended to cure, mitigate, treat, or prevent disease conditions. Statements documenting these intended uses include, but are not limited to, the following:
• “Guaranteed to remove heavy metal ions from the body . . . Kids-ChelatTM contains EDTA, an amino acid that is so effective at removing unwanted minerals and metals from
the body, that is has been the standard FDA approved treatment for lead, mercury, aluminum and cadmium poisoning for more than 50 years.”
• “I recently ordered the Kids Chelat™ and Kids Clear clay baths for my 10 year old son. The results were astounding. My son was able to transition out of his special education classroom at school and he needs his classroom assistant much less.”
• “The Kids Chelat™ totally changed my autistic son from a hand flapping hyper kid to a sweet mellow angel.”
• “As a preventative measure, Bio-Chelat™ keeps any unbound heavy metals ions from being absorbed (or re-absorbed) by the body . . . whether it be metal ions from food, amalgams, or the environment. Bio-Chelat™ has its greatest value for sub-acute or chronic heavy metal toxicity.”
• “My son Anthony is 5 years old and has behavioral and developmental challenges . . . Within a couple of weeks of using Bio-Chelat™ on Anthony. . . his speech returned at a higher level than his usual immature echolaic-type dialogue.”
• “[D]iagnosed as autistic . . . . He started taking Bio-Chelat™ . . . . He became quieter, and his speech improved . . . . Also, he demonstrated improved social response.”
• “I take Bio-Chelat and it has really helped with my neuropathy which creates a burning, stabbing pain throughout my body.”
• “I suffered from heavy pollen allergies . . . However, soon after I started with the product I was almost completely free of any symptoms.”
• “My grandson is reading outloud from books. After being on the spectrum for 3 years and had lost his speech at 3 yrs. we are delighted at his progress! Behavior Balance- DMG™ contributed to this important development.”
• “Flush Out Harmful Acid Waste & Reverse Aging, Illness and Disease!”
• “I have suffered with acid reflux for the past 6 years, and have taken prescription medication (proton pump inhibitors) . . . . Since using the alkalizing drops . . . I have been finally able to get off all the medicines.”
• “I was diagnosed with IC [interstitial cystitis] . . . . I purchased your product, AlkaLife drops . . . . [T]his product . . . will lead me to better pain management, if not a cure.”
• “A powerful anti-bacterial and anti-fungal agent.”
• “We have seen patients who have irritable bowel syndrome, spastic colons, abdominal cramping, rheumatoid arthritis, cystis [sic], fibromyalgia, hay fever, asthma, allergies to foods and medications, benign prostate hypertrophy and acne, have their symptoms completely reverse and the patients return to normal health.”
• “We highly recommend this product to any parent looking for a new and different way to combat Autism and the toxins that attribute to this disorder.”
• “Kids Clear™ Detoxifying Clay Baths not only draw out chemical toxins and pollutants from the body, they also assist in pulling out heavy metals that many doctors agree are a causative factor in the development of neurological and behavioral symptoms.”
• “After using clay baths, a number of parents of an autistic child have noticed dramatic improvement.”
• “What a change! Our almost 5 year old son who is on the spectrum is now doing great. After just the first bath, my husband and I saw results! He’ll turn to look at us (in the eyes) after calling his name only once! He’s using the right words to communicate, and in sentences!! And best of all, he’s smiling and laughing, and just seems happier!”
• “EBN® Clay Baths assist in the removal of both metal and chemical toxins, such as food additives, preservatives, radiation toxins, formaldehyde, cigarette toxins, pesticides, and so on.”
• “In addition to being an excellent internal detoxifying agent, our clay can be very helpful for acute upset stomach, indigestion and diarrhea.”
• “Our clay was used in Malawi . . . to inhibit the incidence of diarrhea in infants and children.”
• “For many years I suffered from migraines . . . and after about 3 months there was a huge improvement.”
• Toxins play a major role in ALS [Amyotrophic Lateral Sclerosis] and other neurological disorders, so neutralizing these toxins is highly important. Two very easy, inexpensive and effective ways to do this is with EBN® Detoxifying Clay Baths and Bio-Chelat™ Heavy Metal Chelator.
Kids Chelat Liquid Chelation Drops, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, and Natur-Leaf are represented as dietary
However, these products are drugs, as defined by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay are also drugs under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because they are intended to affect the structure or function of the body and/or intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. We note that certain versions of Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay represents these products as dietary supplements. To the extent that these products are not intended for ingestion, they are not dietary supplements as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff).
Moreover, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, and EBN Detoxifying Bentonite Clay are “new drugs” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for use and under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for them. FDA-approved applications are not in effect for these products. Thus, the sale of the above-listed products violates these provisions of the Act.
Furthermore, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay are offered for conditions, such as (but not limited to) autism, heavy metal poisoning, and interstitial cystitis, which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use them safely for their intended uses. Thus, your products’ labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). These products are not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that labeling bear adequate directions for use because these products lack approved applications. Section 301(a) of the Act, 21 U.S.C. § 331(a), prohibits the introduction of a misbranded drugs into interstate commerce. Accordingly, the sale of the above-listed products violates these provisions of the Act.
In addition to the new drugs that you market and sell on your websites in violation of the Act, you also market and sell the Heavy Metal Screen Test in violation of the Act. The Heavy Metal Screening Test is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. Your websites
www.evenbetternow.com/
state the following regarding the Heavy Metal Screen Test:
• “By taking a urine sample and mixing it with the test solutions . . . it determines immediately the presence of unbound heavy metal ions in your urine.”
• “The Heavy Metal Screen Test is a wonderful way to know if you have heavy metals in your body AND to show you the progress along the way as you use the Bio-Chelat and EBN Detox clay baths.”
• “The Heavy Metal Screen Test gives you a quick, reliable method for determining if electrically active heavy metal ions are present (ie. being excreted through the urine) at a high, medium, or low concentration, or not at all.”
• “This test is most useful in determining if your body’s detoxification pathways are compromised or not.”
A description of the new drug approval process can be found on FDA’s internet website athttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm.
In addition, information regarding approval or clearance for devices is described at
http://www.fda.gov/cdrh/devadvice/3122.html.
Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO51-2201, Silver Spring, Maryland 20993.
FDA Warning Letter – Dr. Rhonda Henry