Evenbetternow, LLC 10/12/10
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
VIA UPS NEXT DAY
October 12, 2010
Mr. Donald Nichols
Ms. Andrea Nichols
447 W. Silvertip Road
Oro Valley, AZ 85737
1870 W. Prince Road, Suite 54
Tucson, AZ 85705
Re: 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
Dear Mr. and Ms. Nichols:
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.evenbetternow.com, www.evenbetterhealth.com, www.claybathsforkids.com, www.ic-help.com/, www.als-options.com, and 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:
Kids Chelat Heavy Metal Chelator
• “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.”
Bio-Chelat Heavy Metal Chelator
• “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.”
Behavior Balance DMG Liquid
• “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.”
AlkaLife Alkaline Drops
• “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.”
NutriBiotic Grapefruit Seed Extract
• “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.”
In addition to the above-listed products that you market as supplements, your firm also markets Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay. According to product labeling, Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay are intended to cure, mitigate, treat, or prevent disease conditions or to affect the structure or function of the body. Statements documenting these intended uses include, but are not limited to, the following:
Kids Clear Detoxifying Clay Baths
• “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® Detoxifying Bentonite Clay
• “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 supplements. 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/
, and www.theautoimmunesite.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.”
The Heavy Metal Screen Test, used to detect heavy metals in human urine, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. §351(f)(1)(B), because an approved application for premarket approval (PMA) pursuant to section 515(a) of the Act, § 21 U.S.C. 360e(a) or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. §360j(g), are not in effect for it. The Heavy Metal Screen Test is also misbranded under section 502(o) of the Act, 21 U.S.C. §352(o), in that it was manufactured, prepared, propagated, compounded or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. §360; not included in a list required by 510(j), 21 U.S.C. §360(j); and notification or other information respecting the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. §360(k). The issues and violations cited in this letter are not an all-inclusive statement of violations that exist in connection with your products and websites. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter and any other violations you may have. Failure to promptly correct such violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Dr. William Vitale, Compliance Officer, at 949-608-2919.
A description of the new drug approval process can be found on FDA’s internet website at http://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.
Alonza E. Cruse