Inspections, Compliance, Enforcement, and Criminal Investigations
Health Breakthroughs International, LLC 10/22/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
October 22, 2012
In reply refer to Warning Letter SEA 13-04
David Wheeler, Owner
Health Breakthroughs International, LLC
8196 SW Hall Boulevard, Suite 108
Dear Mr. Wheeler:
The United States Food and Drug Administration (FDA) conducted an inspection of Health Breakthroughs International, LLC, located at 8196 SW Hall Boulevard, Suite 108, Beaverton, Oregon, on May 29, 30 and June 6 and 7, 2012. During our inspection, the investigator collected labeling associated with your products. In addition, the FDA reviewed your websites at the Internet addresses www.healthbreakthroughs.net and www.Odisease.com in October 2012.
Based on our review, we have determined that several of your products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC§ 321(g)(l)(B)]. The therapeutic claims on your product labels and websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You may find the Act and the FDA's regulations through links on FDA's home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the claims observed on your www.healthbreakthroughs.net websites include:
• "Vitamin C [an ingredient in your product] ... heal the small intestines."
• " [P]rotection against cold and flu ... "
• "[T]he reduction of pain and inflammation, decrease of systemic candida ... "
Power Herbal Formula
• "Health Benefits . .. Men ... report resolution of erectile disorders."
In addition, your website www.Odisease.com contains disease claims in the form of personal testimonials which establish that these products are intended for use as drugs. For example:
"[A]fter thoroughly reading Dr. Wheeler's website I became convinced that it was better to use his complete healing approach, which he calls the M-Power Perfect Health Program and includes M-Water, Core Nectar and MPS GOLD 100, MPS GOLD 3X ... A nurse who works at the hospital where I do my rounds has been able to resolve years of joint and soft tissue pain caused by fibromyalgia, chronic fatigue syndrome and candida overgrowth ... A patient with progressive dementia has been getting steadily worse over the years but now has regained her ability to dress herself, hold a meaningful conversation for the first time in years, talk on the telephone, surf the internet, participate in the book club and even wants to now write her autobiography! "
"I have used MPS GOLD 100 for. .. fibromyalgia, chronic fatigue syndrome, system yeast, blood sugar imbalances and osteo and other types of arthritic pain ... there are so many health issues - many of them very serious -- that have been turned around with MPS GOLD 100 products in my practice it would be hard to list them all."
"The positive results from patients taking MPS GOLD 100 and MPS GOLD 3X include those with chronic fatigue syndrome, fibromyalgia, multiple sclerosis, osteo and other arthritis type conditions, allergic and other disorders. *** ... "
"Both my wife and partner .. . have seen a broad range of health issues resolved with Dr. Wheeler's products, including ... allergies, fibromyalgia, chronic fatigue, candidiasis arthritic pain, . .. and depression ... --and much, much more. And this is all accomplished with just M-Water and Core Water included in our treatment protocols ... "
"A client. .. presented classic, extreme fibromyalgia symptoms that went undiagnosed and untreated with conventional medicine ... One the symptoms this woman suffered from was overwhelming pain and burning in her eyes ... .I gave her a glass of Core Water and within a few minutes she was able to open her eyes and without pain and burning ... "
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
In addition, even if your products were not unapproved new drugs, they would be misbranded as dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343] as follows:
1. Your Amazing C, MPS-GOLD 100, MPS-GOLD 3X, and Power Herbal Formula products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that their labels fail to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term "dietary supplement" as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product.
2. Your Power Herbal Formula product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the product label fails to identify the part of the plant from which an ingredient is derived in the ingredient statement or in the nutrition label as required by 21 CFR 101.36(d)(1).
3. Your Power Herbal Formula is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] and in accordance with 21 CFR 101.4(h) in that the product label fails to identify the common or usual name of each ingredient. For example, verbenia and Star of Bethlehem are not the common or usual names for these botanical dietary ingredients.
4. Your Amazing C, MPS-Gold 100, MPS-Gold 3X, and Power Herbal Formula products are misbranded within the meaning of section 403(q)(5)(F) in that the labels fail to meet the requirements in 21 CFR 101.36. For example, the label for your Amazing C product does not list the Percent Daily Value for Vitamin C, Calcium, and Magnesium. You fail to list the quantity of each botanical dietary ingredient (or of a proprietary blend of such ingredient) per serving, and you do not list your botanical dietary ingredients in the nutrition information section of your MPS-Gold 100 and Power Herbal Formula label in the form of a "Supplement Facts" panel.
This letter is not an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all of your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
We request that you notify this office in writing, within fifteen working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Cynthia White, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Cynthia White at (425) 302-0422.
Charles M. Breen
cc: Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301