Filed under: FDA
The U.S. Food and Drug Administration (FDA) has found violations in manufacturing practices in half of almost 450 dietary supplement companies it has inspected over the last four years, according to a Chicago Tribune article. The implications of these findings can have serious health problems for consumers. Since dietary supplement manufacturers are the ones responsible for ensuring a product is safe before it is marketed, the FDA inspects companies to check for compliance and takes action only if a product is deemed unsafe after it has been marketed. For more information, see the FDA website’s Dietary Supplements section.
Operation Supplement Safety (OPSS) will launch this summer, with answers to many of the questions you may have about Dietary Supplements. Watch for HPRC’s announcement coming soon.
It’s always a good idea to replace old sunscreen, but next summer you’ll have even more reason to do so. Sunscreen companies have until December 2012 to revise their labels to abide by FDA’s new guidelines. The new labels will prevent manufacturers from false advertising with respect to the level of protection they provide. Sunscreens also will have to go through FDA’s testing to determine their effectiveness.
The new guidelines are summarized below:
Broad-spectrum designation: Sunscreens will have to pass FDA’s broad-spectrum test to be labeled as such. This confirms the sunscreen protects against both ultraviolet A and B rays, both of which contribute to skin cancer and early skin aging.
Use claim: Only broad-spectrum sunscreens with an SPF of 15 or higher can claim to reduce skin cancer risk and early skin aging if used as directed. Sunscreens with SPFs between 2 and 14 can claim only to help prevent sunburn.
Waterproof, sweatproof, and sunblock claims: Sunscreens will no longer be able to claim they are waterproof, sweat-proof, or “sunblock,” since those claims over-exaggerate their effectiveness. No sunscreen is waterproof or sweat-proof without the proper reapplication. Also, sunscreens do not “block” the sun; they reduce the penetration of the ultraviolet rays.
Water-resistance claims: Any sunscreen with a “water-resistant” label must indicate whether it is effective for 40 or 80 minutes while swimming or sweating.
Drug facts: All sunscreens must include standard drug-facts information on the label.
Following in the wake of the Food and Drug Administration’s warning letters to manufacturers and distributors of dietary supplements containing DMAA, the Army announced that its own study on the effects of DMAA on soldiers will continue. Read about the announcement and more in the recent Stars and Stripes article. For more information about the FDA’s action, you can read HPRC’s post, which also includes a link to the FDA news release.
The Food and Drug Administration (FDA) sent warning letters to manufacturers and distributors of dietary supplements containing 1,3-dimethylamylamine (DMAA) due to lack of safety evidence provided before marketing. The FDA states that information about the safety of DMAA as a dietary supplement ingredient has not been identified. For more information, see the FDA News Release and HPRC’s latest on Dietary Supplement Products Containing DMAA.
The goal of National Nutrition Month is to remind Americans to eat healthy and choose foods with good nutrition. The FDA’s theme for 2012 is “Remember to Use the Nutrition Facts Label.” One tool you can use to help make good food choices is the Nutrition Facts label that appears on all packaged foods and beverages. To learn how to read labels, visit the FDA’s web page “Nutrition Facts Label Programs and Materials.”
Many adverse events associated with dietary supplement use go unreported. HPRC has developed one page information resources on how to report adverse events. Warfighters and their families can follow the directions for reporting adverse events to MedWatch (FDA) and Natural Medicines Watch. In addition to these sites, Health care providers can follow step by step directions for reporting via AHLTA.
Recently there has been a multistate outbreak of listeriosis from cantaloupes. The Centers for Disease Control and Prevention (CDC) has an informative report about listeriosis, including symptoms, food contamination, and how to take steps to avoid this serious infection.
Apple juice containing arsenic has been a topic in the news recently. The Food and Drug Administration (FDA) has put together questions and answers to assist the public in sorting through the information. The FDA’s conclusion is that apple juice is safe to drink. More information is available in FDA: Apple Juice Safe To Drink.
According to an Associated Press article from August 2, 2011, the Food and Drug Administration (FDA) has warned the manufacturer of the melatonin-laced brownies known as "Lazy Cakes" that the government considers them unsafe and could seize them from store shelves. The brownies were originally sold under the name Lazy Cakes, but the manufacturer of the product has changed the product name to Lazy Larry.
The FDA said that melatonin has not been found to be safe for use in conventional foods. “On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin,” said the letter, sent last Thursday by the agency’s acting director for the Office of Compliance. Melatonin is not approved for use in any food, the FDA said.
HBB, LCC, the Memphis-based company that makes Lazy Cakes/Lazy Larry, was given 15 days to respond to the FDA with details on specific steps it would take to correct its violation of the ban against melatonin use in food.
It should be noted that the HPRC has been covering Lazy Cakes since they first became available.
Agromod Produce, Inc., is recalling all papayas distributed nationwide and to Canada due to potential contamination with Salmonella Agona. For more information, read the Food and Drug Administration Press Release.