A number of dietary supplement and personal care product manufacturers have recently been the recipients of U.S. Food and Drug Administration (FDA) warning letters over product labels and promotions that purportedly establish the products as drugs under the Food, Drug, and Cosmetic Act. Most of the supplements are advertised as products designed to address blood sugar levels. They include (i) Health King Enterprise & Balanceuticals Group’s “Sugar Balance” and “Blood Pressure Balance”; (ii) PharmaTerra’s “Pro Beta”; (iii) Neuliven Health’s “Glucocil”; (iv) Nature’s Health Supply’s “Diabetes Daily Care”; (v) Naturecast Products’ “Eradicator” and “Nature’s Gold”; and (vi) Internal Remedies’ “Glytain.” Two of the companies, Health Care Products and Anastasia Marie Laboratories, sell topical creams for uses targeted specifically to diabetic patients.
According to FDA, these companies made therapeutic claims for their products on their Websites and product labels, had not secured FDA approval for their products as new drugs and failed to provide serving sizes or adequate directions for use. FDA cited some of the companies for including citations to scientific journals to promote their products, noting that they may become evidence of a product’s intended use. FDA also took issue with the metatags that some of the companies used to direct consumers to their Websites, including “Diabetes,” “Fasting blood sugar,” “Hblac,” “Natural diabetes treatment,” “alternative diabetes treatment,” and “lower blood sugar.” One of the companies apparently included the statement “FDA Approved” on its product label, which FDA said was false. See FDA Warning Letters, July 11 and 15, 2013.