Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm361842
Timestamp: 2019-02-20 06:19:45
Document Index: 275594261

Matched Legal Cases: ['§ 321', '§ 321', '§ 355', '§ 331', '§ 352', '§ 331']

Health King Enterprise & Balanceuticals Group, Inc. 7/11/13
Health King Enterprise & Balanceuticals Group, Inc.
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed your websites, www.healthkingenterprise.com and www.balanceuticals.com, which redirects to www.healthkingenterprise.com, in June 2013 and has determined that you take orders there for your products, “Sugar Balancer”, “Blood Pressure Balance”, Bio-Defender”, “AlcohLiver Fix” and “Super Reishi Essence,” which the websites promote 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 the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of the website claims that provide evidence that your products are intended for use as drugs, on your www.healthkingenterprise.com website, include the following:
“Sugar Balancer”
On the “Chinese Uses and More Info on This Formula” link on a page titled “Summary of Modern Studies on Huafen Yuxiao (Sugar Controller Formula™) Capsule”:
· “Chinese Use: Diabetes”
· “Rhizoma Dioscoreae, Radix Ginseng rubra, Fructus Lycii, Radix Rehmanniae, Rhizoma Anemarrhenae, Radix Puerarine and Fructus Corni.”
· “[l]owers the blood glucose …, prevents and treats diabetes …, antagonizes the rise of blood sugar ....”
· “Gastric infusion of LBP lowers the blood glucose in normal mice, prevents and treats hyperglycemia ….”
· “Rhizoma Anemarrhenae polysaccharide…markedly lowers blood sugar ….”
· “Fructus Corni alcohol extract yields marked effect of lowering blood sugar in diabetes animal models …, lowers the platelet aggregation…of whole blood.”
· “Its ether and ethyl acetate extracts lowers the blood glucose in rat induced by streptozotocin, its active ingredient being ursolic acid.”
· “Clinically, this product was applied in diabetes mellitus….”
· “Diabetes mellitus: 396 cases were treated. The effect of ameliorating the symptoms was better than oral hypoglycemic agents with satisfactory effect on lowering blood and urine glucose, the rate of marked effect being 21%, amelioration rate 63.1%, total effective rate being 84.1%.”
“Blood Pressure Balance”
On the“Chinese Uses and More Info on This Formula” link on your “Blood Pressure Balance” product page, which opens to a page titled “Summary of Modern Studies on Gegen Pingya (Blood Pressure Balance) Capsule”:
· “Chinese use: Hypertension”
· “Radix Puerariae in this product yield effects of blood pressure lowering…antipyretic, anti-tumor, inhibition of platelet aggregation and lowering blood sugar”
· “Clinically, this product is applied in hypertension, coronary disease, angina pectoris, sudden deafness and … headache.”
· “Hypertension: 71 cases were treated, the effect for headache is 82.9%, the total effective rate is 51.8%; for vertigo, 72%, markedly effective rate 33.4%; for neck pain, 84.7%, markedly effective rate 50%”
· “Coronary disease, angina pectoris, 120 cases were treated with a total effective rate of 91%, markedly effective rate 68.6% and improvement of EKG 51.2%.”
· “Sudden deafness: 176 cases were treated, with a total effective rate of 79.5%, markedly effective rate 23.3%.”
· “[H]eadache: 42 cases were treated, with a total effective rate of 83%, markedly effective rate 21.4%.”
“Bio-Defender”
On the “Click here for More Info on BioDefender” link, on a page titled, “BioDefense: A Natural Alternative to Antibiotics Antiviral, Antifungal and Antibacterial without Hurting the Good Ones”:
· “Protect Yourself from Viruses, Bacteria, and Fungal Infections”
· “How a combination of natural compounds effectively destroys viruses, bacteria, fungi and can even protect or destroy Bio Terrorist Diseases such as Anthrax”
Under the heading “Monolaurin”
· “Monolaurin destroys lipid coated (fat coated) viruses and bacteria. This includes Herpes, Chlamydia, helicobacter [sic] pyloris, Epstein Barr, and influenza …. There are many pathogens against which Monolaurin is effective. A significant pathogen that seems to be susceptible to Monolaurin is HIV.”
· “[A] number of studies have been under way, studying the highly successful treatment of Monolaurin against the HIV.”
· “Clinical trials using monoglycerides such as monolaurin for destroying bacteria, viruses, and fungi are on the rise. …the susceptibility of Neisseria gonorrhoeae (gonorrhea) to several medium-chain fatty acids and their 1-monoglycerides causes the fastest and most effective killing of all strains of N. gonorrhoeae.”
Under the heading “Extract of Olive Leaf”
· “Another active ingredient in the olive leaf has been shown to be lethal to a number of pathogenic bacteria, viruses and fungi. Research, from Upjohn…list 56 pathogens inhibited by Olive leaf including herpes, parainfluenza, encephalomyocarditis, Newcastle’s Disease, some forms of polio, and plasmodium falciparum (virus that causes malaria)
· “[O]live leaf inactivates smallpox, Ebola, plague, Epstein-Barr, and is effective against protozoan caused diseases.”
· “Extract of olive leaf is very powerful and has been documented to destroy anthrax and the plague.”
Under the heading “IP6”
· “IP 6 effectively starves bacteria, viruses and fungi to death”
· “IP6 prevents cancer growth and starves it to death…”
· “IP6, taken as a supplement, can work against these cancers.”
Under the heading “Supportive Nutrients,” sub-heading “Goldenseal”
· “Berberine seems to be the ingredient that acts as an antibiotic…”
· “Goldenseal actives [sic] and mobilize macrophages (the large white blood cells that attack bacteria, viruses, fungi…”
· It also has the ability to inhibit tumor formation, suggesting anti cancer or anti tumor ability”
Under the heading “Supportive Nutrients,” sub-heading “NEEM Leaf”
· “The neem tree (azadirachta India), native to India and Burma, produces a variety of compounds found to be effective ingredients against viruses, bacteria, and fungi.”
· “It is the compounds found in the neem leaf that exhibit remarkable antibacterial, antiviral and anti fungal qualities.”
· “Compounds of the Neem leaf are azadirachtin, gedunin, nimbin, nimdibin, nimibidol, queceretin, salannin and sodium nimbinate. These compounds have been shown to stimulate macrophages (our white blood cells) to attack the foreign virus, bacterial or fungal particles.”
Under the heading “BioDefender against Bioterrorist Agents: BioDefender as an Anti – Bioterrorist Supplement
· “As the idea for this formula was a response to bioterrorist attack, it is certainly a good product for that purpose. All ingredients in this formula are specifically documented to destroy bacteria, viruses and fungi.”
· “BioDefender is not only ‘defending’ our body from bio-terrorism, but also goes ‘on the attack’ to destroy pathogens.”
“AlcohLiver Fix (Yanggan)
· “[V]irus inhibiting properties…”
On the “Chinese Users and More Info on This Formula” link:
· “Prevents Fatty Liver Disease”
· Treats and Protects Chemical Liver Damage (Poisoning and Alcohol Overdoses”
· “Has therapeutic aiding effect towards viral hepatitis”
· “Decreases the depravation of chronic hepatitis and liver cirrhosis”
· “The effect of the magnoliavine fruit on protecting damaged liver not only shows on lowering the serum GPT…”
· “It is mainly used to treat acute and chronic hepatitis, liver cirrhosis, fatty liver, and toxic liver damage.”
· “Indications:
· People who suffer from damaged liver functions
· Long-term alcoholic or smoker”
“Super Reishi Essence”
· “[S]ide-effect of chemo & radiation”
· “The anti-tussive,…hypotensive,,,, and antibacterial effects of Reishi are well known.”
· “Chinese doctors prescribe it for …neurasthenia, insomnia, tuberculosis, hepatocirrhosis, bronchial cough in elderly persons and carcinoma, etc.”
· “[I]nhibit metastatic tumor…reduce cholesterol…”
On the “Chinese Uses and More Info on this Formula” webpage link:
· “[I]nhibit metastatic tumor (S180 sarcoma)…reduce cholesterol…”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under Section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA as described in Section 505(a) of the Act [21 U.S.C. § 355(a)], see also Section 301(d) of the Act [21 U.S.C. § 331(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, “Sugar Balancer”, “Blood Pressure Balance”, Bio-Defender”, “AlcohLiver Fix” and “Super Reishi Essence,” 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 layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the Act [21 U.S.C. § 331(a)].
Your firm’s response should be sent to: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 391124) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.
Health King Enterprises & Balanceuticals Group, Inc. - Close Out Letter 6/24/14