Inspections, Compliance, Enforcement, and Criminal Investigations
NanoLiposomal Nutritionals 11/22/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612
Telephone (949) 608-2900
Fax: (949) 608-4415
RETURN RECEIPT REQUESTED
November 22, 2011
Ms. Hilery Owens
2804 46th Street
San Diego, California 92105
Dear Ms. Owens:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at www.healthyitems.com and www.nanoliposomals.com in October 2011 and has determined that your products "Cactus Plus -Herbal Diabetic Formula", "Diatrol Plus", "OXY-CAPS", "Liposomal CAN - HELP", "Liposomal CoQ10", "Liposomal CURCUMIN", "Liposomal CAN-HELP", "Liposomal GLUTATHIONE," "Liposomal RESVERATROL" and "Liposomal Synapse Plus" 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 U.S.C. § 321(g)(1)]. The claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. Examples of some of the claims observed on your website www.healthyitems.com include:
"Cactus Plus- Herbal Diabetic Formula"
• "Cactus Plus - Herbal Diabetic Formula ... offers powerful. .. support for people suffering from Type II, adult onset diabetes."
• "Cactus Plus - Herbal Diabetic Formula ... help the body to better regulate blood glucose or decrease complications of Type II Diabetes .... "
• "In adult onset diabetes, the symptoms occur because the insulin does not work properly. Diatrol Plus™ is a sugar balancing formula that can help eliminate sugar-lowering medications, as it helps normalize blood-sugar levels."
• "Dr. Donsbach has developed a revolutionary formula to aid people suffering from Type II, adult onset diabetes."
"Liposomal CAN-HELP Complex"
• With respect to the ingredient "Resveratrol," you say:
o "Cancer researchers say it prevents and even stops cancer cells."
• With respect to the ingredient "Curcurmin," you say:
o "Modern research says that curcumin [an ingredient in your product] is so powerful that it can prevent damage in normal tissue from radiation, but knows the difference between normal and cancerous tissue and only protects the normal tissue! Other researchers say that it is a better cancer fighter than any chemo they know."
Examples of some of the claims observed on your website www.nanoliposomals.com include:
• "Absolutely incredible results are being obtained in formerly difficult-to-treat conditions such as Parkinson's Disease and Autism, as well as, heart disease and cancer."
• "[C]urcumin is believed to ... relieve arthritis."
• "[C]urcumin effectively prevents precancerous changes with DNA and interferes with enzymes needed during cancer promotion."
• "Curcumin's anticancer effects are due also to its ability to induce apoptosis (cell death) in cancer cells without cytotoxic effects on healthy cells."
• "Anti-Cancer ... Formula"
• "Excellent results are being obtained in formerly difficult-to-treat conditions such as Parkinson's and Autism."
• "Science Magazine published an article from the University of Illinois that stated: 'Resveratrol can inhibit all three· stages of chemical carcinogenesis - tumor initiation, promotion and progression.'
• "Resveratrol also has serious benefits for the heart, it blocks platelet aggregation which can lead to clots and it acts to relax the walls of the blood vessels which could have benefit for high blood pressure."
• "In addition, new resveratrol research indicates it is 'a valuable new strategy for treating insulin resistance and type 2 diabetes.'
"Liposomal Synapse Plus"
• "NanoLiposomal delivery of glutathione [an ingredient in your product] ... will help alleviate the symptoms of Parkinson's and other debilitating neuromuscular disorders."
• "Absolutely incredible results are being obtained in formerly difficult-to-treat conditions such as Parkinson's and Autism, as well as Heart Disease and Cancer."
• "Liposomal SYNAPSE+ Neuromuscular Nutritional Support Formula offers the most up-to-date ... approach to neuromuscular disorders such as Parkinson's Disease."
Your products are not 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.
Furthermore, your products--specifically, "Cactus Plus - Herbal Diabetic Formula," "Diatrol Plus," "Liposomal CAN-HELP Complex," "Liposomal CoQ10," "Liposomal CURCUMIN," "Liposomal CAN-HELP, " "Liposomal GLUTATHIONE," "Liposomal Resveratrol," and "Liposomal Synapse Plus" --are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layman can use these drugs safely for their intended uses. Thus, these products are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. 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 website, product labels, and other labeling and promotional materials for 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 do so may result in enforcement action 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].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. 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.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact Dr. William Vitale, Compliance Officer at 949-608-2919.
Alonza E. Cruse