FDA Advisory No. 2013-037
PUBLIC WARNING ON UNREGISTERED "GREEN BARLEY - A TOTAL FOOD"
In an advisory, the Food and Drug Administration (FDA) warns the public on buying unregistered GREEN BARLEY- A Total Food, a power juice drink distributed by Health Wealth International Corporation and manufactured by Global Partners Inc.Under FDA Advisory No. 2013-037, released on Friday, the product is retailed at the markets and online shops at around P275 to P300 per bottle; it is in powder form and sold in plastic bottles. The product claims to be therapeutic for diseases or ailments like dengue, cancer, diabetes, leptospirosis, high blood pressure, high blood sugar, high cholesterol, arthritis, rheumatism, gout, rhinitis, impotence, goiter, arterial venous malformation, pre-menstrual tension, menopausal complaints, frequent urination, and myoma, among others.
As an unregistered health product, Green Barley also has unapproved health claims that it heals wounds and treat skin diseases like fungal infections by topically applying the powder juice on the skin. As a non-pharmaceutical product, it advises the consumer and patients to drink one bottle for a week or two, and for serious disease one bottle daily.
A quick search for Green Barley at the FDA website, www.fda.gov.ph, reveals that the product is unregistered with the FDA. Initial findings also showed that the registration number, BFAD FR-64136, that Green Barley claims to be using as food product was issued in 2007 and has expired in 2009. The product has been denied registration twice due to non-compliance with the FDA Rules and Regulations. Although Global Partners Inc. submitted an application for a new Certificate of Product Registration to the FDA Center for Food Regulation and Research on September 2, 2013, this is still under evaluation and is not yet authorized to market.
Attachment:
http://www.fda.gov.ph/attachments/article/110925/FA2013-037%20-%20Public%20Warning%20on%20Unregistered%20Green%20BArley%20-%20A%20total%20Food.pdf
All consumers are hereby warned to remain vigilant against unscrupulous traders and retailers of food supplements who are making false and deceitful claims which promise cure against infectious and non-infectious disease, such as cancer and diabetes. To verify if a health product is registered with the FDA, please visit the FDA website (www.fda.gov.ph) and type in the name of the product in the search bar.
To report any adverse event or reaction or unregistered products, kindly send an email at report@fda.gov.ph. For more information and inquiry, kindly send an email via info@fda.gov.ph.
All field Food and Drug Regulation Officers are already instructed to seal, inventory and confiscate Green Barley and other unregistered food supplements and report them to the FDA for appropriate regulatory and legal action.
Source: http://www.fda.gov.ph/advisories/food/110925-fda-advisory-no-2013-037
FDA
