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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nature's Health Company, LLC 9/21/10

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740

 

SEP 21 2010


WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Dr. Ceyu Cao
Nature's Health Company, LLC
811 S 700 E
Salt Lake City, Utah 84102


2212 S West Temple #10
Salt Lake City, Utah 84115


Re: CFSAN-OC-10-30


Dear Dr. Ceyu Cao:


This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address, www.nature-s-health.com and has determined that the products "Cardiac Balance I(60)", "Cardiac Balance II", "Notoginseng", "Shark Cartilage (30)", "Red Sage", "Rubber tree", "Liver-kidney Balance", "Milk Thistle Seed", "Multisoft I", "Flavescent", "Blood sugar balance III", "Balsam pear", "Cinnamon", "Cell balance", "Cell Balance II (atteannuina)", "Nerve Relaxer", "Male balance" and "Urinary Balance(60)" 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)(B)]. The therapeutic claims on your 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 the products with these claims violates the Act.


Examples of some of the claims observed on your website www.nature-s-health.com include:

 
Under the sub-title "Stroke and Herbs":


Cardiac Balance I(60)


• "[l]ncreases contraction force of cardiac muscle"
• "[C]ontrol arrhythmia... "


Cardiac Balance II


• "[A]nti-clogging enzymes, prevent agglomeration of platelets and thrombosis, decrease blood
viscosity."
 

Notoginseng


• "Notoginseng can stop congealing in vessel, thin blood and dissolve blood clots."


Your website also contains disease claims in the form of personal testimonials under the sub-heading


"Testimonial":


• "Stroke and Herbs"


• "[D]iagnosed as coronary artery disease in hospital, and she also had high cholesterol.. ...Cardiac Balance I & II.. ..with medication. Half a year later, the symptoms disappeared or alleviated significantly."


• "1 pill a day-notoginseng. First bottle showed improvement in hand strength, Stroke patient, left side paralysis."


On your webpage under the sub-title "Osteoporosis and Herbs":


Shark Cartilage(30)


• "[T]he presence in shark cartilage of an anti-angiogenesis substance which inhibits the growth of blood vessel into solid tumors and thus keeps tumors from growing."


• "Many medical conditions and diseases such as arthritis, psoriasis, and cancer require blood supply and new blood vessels in order to continue Shark cartilage appears to contain a substance with the ability to block the growth of new blood vessels."


On your webpage under the sub-title "High Blood Pressure and Herbs":


Red Sage


• "[H]elp to decrease blood pressure, dilute the viscosity of blood and prevent agglomeration of platelets and thrombosis."


Rubber tree


• "[R]elaxant effect on coronary artery."


Liver-kidney Balance


• "[P]ostpone progression of chronic disease ...."


Your website contains disease claims in the form of personal testimonials under the sub-heading


"Testimonial":


• "I've had high blood pressure (untreated) for 25 years. I've used liver-Kidney and Rubber Tree for 2 months and have enjoyed a drop in blood pressure."


On your webpage under the sub-title "Hepatitis A,B,C and Herbs":


Milk Thistle Seed


• "[A]lters the membranes of hepatic cells to inhibit passage of toxins and increase cellular regeneration... "


• "It helps relieve symptoms of acute and chronic hepatitis, hepatocirrhosis, fatty liver, damage of liver."


On your webpage under the sub-title "Multiple Sclerosis and Herbs"


Multisoft I


• "[C]an relieve and reduce autoimmune reactions and diminish tissue damage caused by abnormal immune system attacks upon native CNS tissues."


• "[P]revents blood platelets from agglutination... "


Flavescent


• "[R]elieve the symptom of autoimmune system disease."


Your website contains disease claims in the form of personal testimonials under the sub-heading


"Testimonial":


• "[M]s experienced numbness in hands and feet. Woke up with tenatic hands. And she suffered a lot from cramp and shrinking in crura started taking Multisoft I and Multisoft II from then. After two and a half months, shrinking of legs stopped, feeling came back, and the cramp disappeared."


On your webpage under the sub-title "Anti-Diabetes (hyperglycemia)"


• "[H]elps balance blood glucose levels."


• "[R]educe excessive levels of cholesterol, fat and glucose ....the blood, which is beneficial to diabetics."


• "For type I Diabetes patients, please choose "Blood Sugar Balance II."


• "For type II Diabetes patients."


Blood sugar balance III


• "[B]alance blood glucose level.. .."


• "[B]lood sugar is brought down naturally."


Balsam pear


• "[I]mprove fasting blood glucose levels."


Cinnamon


• "[C]innamon makes fat cells 20 times more responsive to insulin..... thus controls the level of glucose in the blood."


Your website contains disease claims in the form of personal testimonials under the sub-heading


"Testimonial":


• "I have been taking Rubber Tree, Red Sage, Blood Sugar IV for two months, my blood sugar & blood pressure are under control."


On your webpage under the sub-title "CancerEase":


• "Nature's Health Cell Balance contains polyphenols....which have been demonstrated to largely reduce the viability of tumor cells."


• "[I]nduce apoptotic cell death in human leukemia HL-60 cells."


• [R]educe cervical and other cancers."


Cell Balance


• "[R]educe the viability of tumors."


Cell Balance II(atteannuina)


• "[D]estroy the inner structure of cells and kill cancer cells."


• "[A]nti-tumor function."


On your webpage under the sub-title "Shake and Parkinson Disease and Herbs":


Nerve Relaxer


• "[H]yperactivity in children....Parkinsons disease ....."


• "[T]reat....panic attacks."


• "[P]arkinsons disease, epilepsy, shingles....may all be relieved by this wonderful safe, gentle nervine herb."


• "It sedates, soothes and relaxes, helps relieve muscular spasms, and tends to relieve pains."


Your website contains disease claims in the form of personal testimonials under the sub-heading


"Testimonial":


• "[S]he came to me with hands and lip shaking. She had been persisting taking Nerve Relaxer, Ginkgo & Rhodiola and Liver-Kidney Balance for 6 months till June 15, 2002 when she returned to visit me, her symptoms disappeared."


On your webpage under the sub-title "Gonorrhea and Herbs":


Male Balance III


• "Baicalein has function to restrain the bacteria.... Baicalein can restrain the activity of Neisseria gonorrhoeae, which is the causative agent of gonorrhea."


• "Geniposidde helps to relieve .... (infection and inflammation due to bacteria), and restrains the activity of Neisseria gonorrhea."


Urinary Balance


• "[I]nduce diuresis to reduce edema, special good effect to infection of urinary tract."


Your website contains disease claims in the form of personal testimonials under the sub-heading


"Testimonial":


• "[M]ale, 45 years old. He got herpes on his penis, with pain and itch. He came to see Dr. Cao in 1995, who suggested him to take Male Balance III 3 capsules before meals three times daily. After finishing two bottles, the symptoms got significantly relieved, and he felt comfortable."


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.


Furthermore, because your products is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, their 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)]. 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 directed to, Compliance Officer, U.S. Food and Drug Administration. If you have any questions regarding any issues in this letter, please contact Howard Manresa at 303-236-3019.


Sincerely yours,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition