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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Herbal-supplements-for-you 12/2/10

  

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

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

                                                                                                                                                                                                                                                                                           

                                                                                                                                            

                   

DEC 2 2011                                                                             

WARNING LETTER

www.herbal-supplements-for-you.com

c/o herbalsupplementsforyou@gmail.com

To Whom It May Concern:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.herbal-supplements-for-you.com in October 2010 and has determined that the “Karela”, “Garlic (Lasuna)”,“Shallaki and “Triphala” products offered for sale on your website is promoted for conditions that causes it to be a drug 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 website establish that the products are  drugs because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. 

The following claims were noted on your website:

Karela

•“Karela - Lower Blood Sugar”
•“Karela . . . has been proven by western scientists to contain insulin, inhibit HIV-1 infection and act as an anti-tumor agent.”
•“Karela’s (Bitter melon) fruits have long been used in India as a popular remedy for diabetes mellitus.”

Under the heading, “Benefits of Bitter Melon/Karela”: 

“is useful in treating Diabetes.”
“It is helpful to reduce sugar levels in blood and urine”

Under the heading, “Following are the functions that Karela performs in the body”:

•Piles
•Skin diseases
•Leprosy
•Alcoholism
•Cholera
•Diabetes mellitus
•Infections
•Anthelmetic [sic

Under the heading, “Health Benefits of Karela”: 

•“It is also helpful in…diseases like fissures, hemorrhoids, and fistulas.”
•“useful is destroying worms in gastro intestinal tract.”
•“helps us from infection from microorganism.” 

Garlic (Lasuna) 

“Garlic . . . is famous as an antibiotic herb. Its main area of utilize in the treatment of infectious disease is in the throat and lungs and the digestive tract.”
“[I]t is extremely helpful in treating any form of flu or colds, from a mild head cold to pneumonia. It is useful for bronchial conditions such as inflammatory disease, asthma, tuberculosis and hepatopulonary [sic] syndrome.”
“In the digestive tract, garlic has been shown to be effectual against a wide variety of germs and fungi including E. coli, staphylococci, Salmonella, Streptococci, and Candida albicans. This makes garlic useful in the treatment of yeast infections . . .” 

Under the heading, “Medical Use”: 

Garlic has been used in recent medicine for high cholesterol, high blood pressure…and immune deficiency diseases.”
“A low incidence of stomach cancer in populations that eat large quantities of…garlic has been observed.”

Under the heading, “Heart and blood vessels”:

•“Clinical trials show that Garlic may aid in the treatment and prevention of coronary artery disease, possibly for … hypercholesterolaemia and hyperlipidaemia and mild hypertension.”
•“Garlic can also help other heart conditions such as high cholesterol levels and stroke, blood pressure, heart attack, angina and atherosclerosis (hardening of the arteries).” 

Under the heading, “The Physiological Effects of Garlic”:

•Raw Garlic is a potent natural antibiotic and, while far less strong than recent antibiotics, can still kill some strains of bacteria that have become immune or resistant to modern antibiotics.”
•“Garlic has anti-viral properties and anti-fungal.”
•“Garlic (lasuna) dramatically reduces yeast infections due to Candida species.”
•“Garlic (lasuna) lowers blood pressure…”
•“It lowers LDL Cholesterol…”
•“It also helps to reduce atherosclerotic buildup (plaque) within the arterial system.”

Under the heading, “Health Benefits of Garlic”:

•“It is extremely effective in the treatment of high cholesterol and other heart related problems.”
•“Garlic works as natural antibiotic by decrease [sic] bacterial infection and its growth.”
•“Garlic has been used since ages as natural dewormer in children.”
•“It is also very helpful to cancer patients as it inhibits growth of cancerous cell.”

Shallaki

•“Shallaki -- Joint Pain Relief”
•“Its anti-inflammatory action is used for the treatment of gout , low back pain,  myositis, rheumatoid arthritis, osteoarthritis and fribrositis.
•"It is also found to be anti-fungal, analgesic [sic], anti-bacterial…”
•“Boswellia Serratta (English name for Shallaki) is mostly used for prevention of…rheumatic disorders…”

Under the heading, “Health Benefits of Shallaki”:

“Shallaki also possess anti cancerous properties”
“Shallaki helps in relieving pain …”
“It works as anti-inflammatory substance …”
“It is indicated in arthritic problems like osteoarthritis, rheumatoid arthritis, gout, joint pains and skeletal muscle pain.”
“It is also indicated in back pain and lymphadenopathy.”
“It is very commonly used as a wound healer herb …”

Triphala

Under the heading, “Benefits of Triphala”:

•“Very Effective in Ulcerative Colitis and Irritable Bowel Syndrome”
•“Triphala…corrects diverticulitis(diverticulosis) and acts as an expectorant”

Under the heading “Colon Cleansing”:

 •“It is also widely taken for all eye diseases including the treatment of conjunctivitis, progressive myopia, the early stages of glaucoma and cataracts.” 

Your products as noted above 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)]. Under section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.

Furthermore, because your products are 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, the labeling fails to bear adequate directions for its intended uses, causing the products 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.

Sincerely,                                                                   

/s/

Joann Givens
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition