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Americans' Caffeine Intake Driven by Coffee Consumption

Results of a study said to be the first population-based research to estimate human caffeine intakes in more than 10 years suggest that overall mean caffeine intakes in the United States remain driven by the consumption of coffee and, to a lesser extent, tea and carbonated soft drinks. Diane Mitchell, at al., "Beverage Caffeine Intakes in the U.S.," Food and Chemical Toxicology, November 1, 2013. The study, which analyzed data from seven-day diet records of 37,602 Americans, indicated that caffeine intakes from so-called energy drinks-shots and beverages -- contributed "minimally," or less than 2 percent, to total caffeine intakes.

The study showed that the greatest proportion (9-10 percent) of caffeinated beverage consumers consuming energy drinks were teenagers (13-17 years old) or young adults (18-24 years old); only 5 percent of total caffeine intake, however, was attributable to energy drink consumption in these groups. Meanwhile, the mean daily intake of those who did consume caffeine was 165 mg/day and mean intakes were highest in the 50-64-year age range at 226 mg/day. According to the study, even the heaviest caffeine consumers were not drinking huge amounts; intakes at the 90th percentile from all caffeinated beverages were slightly above 400 mg/day for adults age 35 years and older. Although the United States has no specific recommendations for caffeine intakes, the U.S. Food and Drug Administration has indicated, that for healthy adults, caffeine intake up to 400 mg/day is not associated with adverse health effects.

FDA Announces New Adverse Event Reporting Portal for Dietary Supplements

The U.S. Food and Drug Administration (FDA) has announced that "in the interest of efficiency and as a convenience to dietary supplement manufacturers, packers and distributors, as well as the public at large," it will now accept voluntary and mandatory dietary supplement adverse event reports via its new online portal. The agency notes that with more than 85,000 dietary supplements on the market and no product-specific registration requirement, adverse event reporting is "invaluable" in identifying harmful products and "critically important" in protecting consumers' health and safety.

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), the dietary supplement maker, packer and distributor whose name appears on the label of a dietary supplement marketed in the United States must report to FDA information about any serious adverse events received regarding its dietary supplement products when used in the United States.

For mandatory reporters, other than a new electronic alternative to the MedWatch 3500A paper form, the announcement does not change existing reporting requirements, and the agency will continue to accept paper 3500A and 3500 forms. Noting that anyone can submit a voluntary dietary supplement adverse event report (3500 form), FDA encourages physicians, in particular, to file voluntary reports when their patients have experienced adverse events associated with dietary supplements. FDA has sent letters to all dietary supplement manufacturers, packers and distributors encouraging them "to use the new capability and detailing its benefits." See FDA News Release, January 13, 2016.

$4.2 million paid to man harmed by supplements with Anabolic steroids

According to a news source, a man who claims that his kidneys and liver were destroyed by a dietary supplement produced through small-batch production using imported ingredients, has settled with the manufacturer, distributor and retailer for $4.2 million. Lineberger v. Max Muscle Mktg., Inc., No. 30-2010- 00423797 (Cal. Super. Ct.). The “Epio-Flex” supplement that the plaintiff purchased was later allegedly found to be made with two prohibited steroidal compounds—Madol and Superdrol.

His attorney said that the case illustrates the dangers of small-batch production in which sole proprietors fill orders for major manufacturers and wholesalers using contract manufacturers facing little oversight in obtaining their ingredients. Here, the Texas-based contract manufacturer had no standing inventory and filled orders only as needed using ingredients from China.

The Anabolic Steroid Control Act of 1990 reportedly contains a loophole allowing chemical suppliers to adjust their compounds slightly to circumvent the prohibition on any compound that mimics the effects of testosterone. The U.S. Food and Drug Administration (FDA) has apparently found an “alarming variety” of ingredients in body-building supplements, which ingredients are the same or similar to those active in FDA-approved drugs. Some over-the- counter dietary supplements have been found to contain, in addition to steroidal compounds, beta blockers, anti-coagulants, anti-convulsants, and nonsteroidal anti-inflammatory drugs. See Law360, February 3, 2016.

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