FDA Advisory No. 2013-037 PUBLIC WARNING ON UNREGISTERED "GREEN BARLEY - A TOTAL FOOD" The public is warned against buying GREEN BARLEY - A Total Food (Figure 1), powder juice drink distributed by Health Wealth International Corporation and manufactured by Global Partners Inc. that is not registered with the Food and Drug Administration (FDA). The product is sold at around 275 to 300 Php per bottle, both in the market and in online shops. It is sold in plastic bottles, and the product is in powder form. Green Barley is making false health and therapeutic claims as shown in its advertisement, both in print and digital media. Its therapeutic claims include 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 comaplaints, 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 a day. A quick SEARCH at the FDA website (fda.gov.ph) for Green Barley showed that the product is unregistered with the FDA. Initial findings also revealed that the registration number that Green Barley claims to be using (BFAD FR-64136) of Green Barley as food product, was issued in 2007 and has expired in 2009. The product has been denied registration twice because they cannot fully comply 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. 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 (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 email us at [email protected]. For more information and inquiry, kindly email us via [email protected]. 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. Attachments: FA2013-037 - Public Warning on Unregistered Green BArley - A total Food.pdf
Posted on: Tue, 24 Sep 2013 02:41:57 +0000
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