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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.balanceayurvedic.com 7/9/09

   

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

Public Health Service
Food and Drug Administration
  Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506

 

WARNING LETTER

W/L 24-09

 


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


July 9, 2009


Chandru Shahani
Balance Ayurvedic Products
608 Camino Grove Ave
Arcadia, CA 91006

Dear Mr. Shahani:
This is to advise you that in June 2009 the Food and Drug Administration (FDA) reviewed your website at the Internet address www.balanceavurvedic.com and has determined that your brand of Balance Ayurvedic Products ("Men's Vitality Herbal Formula," "AyurSoothe Herbal Formula," "AyurVitality," "AllerSupport Herbal Formula," and "AyurSlim Herbal Formula") are promoted for conditions that cause them 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 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 these products with these claims violate the Act.

Examples of some of the claims observed on your website include:

Men's Vitality Herbal Formula

• "provides nutritional support for all types of erectile dysfunction."
• "Used in symptoms related to enlarged prostate, impotence, infertility for men ... "

AyurSoothe Herbal Formula

• "AyurSoothe ... provides nutritional support for .. .impotence and herpes."
• "Used in symptoms relating to ... gastritis ... herpes, hives ... rheumatoid arthritis, sore throat ... ulcers, and urinary tract disorder."

AvurVitality Herbal Formula

• "AyurVitality provides nutritional support for a variety of ailments such as impotence,urinary tract infections, osteoarthritis, diabetes, infertility, obesity, gout, and rheumatism."
• "for those recovering from fractures and torn ligaments as it helps accelerate recovery time."
• "It is also famous for its ability to balance blood sugar levels."
• "Used for symptoms relating to asthma ... whooping cough ...  gout, high cholesterol, hyperglycemia, impotence ... tendonitis, urinary tract disorders "

AllerSupport Herbal Formula

• "This ancient formula has been used for bronchitis, hives, skin diseases ...sinusitis, and atopic eczema."

AvurSlim Herbal Formula

• "AyurSlim provides nutritional support for reducing... tumors."
• "AyurSlim ... has been used for centuries to fight symptoms of ... obesity."

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, they are "new drug" 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. Your "Men's Vitality Herbal Formula," "AyurSoothe Herbal Formula," "AyurVitality," "AllerSupport Herbal Formula," and "AyurSlim Herbal Formula" products are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and its 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 website, product labels, and other labeling and promotional materials for your product to ensure that the claims you make for your product do not cause them to violate the Act.

You should take prompt action to correct these deviations 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:

Dennis Farley
Acting Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612-2506

If you have any questions about the content of this letter, please contact John Stamp, Compliance Officer, at 949-608-4464.

Sincerely,

Alonza E. Cruse

Director, Los Angeles District


Cc: Jeff Farrar, DVM, PhD, MPH
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413