Posts Tagged ‘fda’
FDA Notified Consumers About Ejaculoid XXTREME
ISSUE: FDA notified consumers that lab analysis of lots of ejaculoid XXTREME and stimuloid II found that the products, sold as dietary supplements, contain sulfoaildenafil, similar to sildenafil, which is an active ingredient of an FDA-approved drug for male erectile dysfunction, making these products unapproved drugs. This active drug ingredient is not listed on the product labels and may interact with nitrates found in drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
BACKGROUND: The recalled products were distributed in black plastic bottles to distributors and via internet sales. The company press release contains specific lot numbers and additional recall information.
RECOMMENDATION: Customers who have any of the above products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
FTC Wants to Impose Stricter Rules on Advertising of Dietary Supplements
World CLass Nutrition wants to keep supplements users aware of how the government is trying to take away your freedoms. Over the last week or two, a joint House-Senate conference committee has been considering ways to reconcile two competing federal Wall Street reform bills and turn them into a single bill that both chambers can support. The US House’s Wall Street Reform and Consumer Protection Act of 2009 (HR.4173) and the US Senate’s Restoring American Financial Stability Act of 2010 (S.3217) differed in cost and content, most notably for us in that the Senate version did not give the broad new regulatory powers to the Federal Trade Commission (FTC) that the House version would. By removing limits on its power that are enshrined in current laws, the FTC could impose harsh new requirements on all businesses, even those completely unrelated to Wall Street, banking, or the financial sector; including dietary supplement manufacturers.
How do we expect that the FTC would act if given such new power? The agency has indicated that it wants to impose stricter standards on any advertising of dietary supplements. Past consent decrees that settled disputes with supplement companies have required strong disclaimers and much more evidence to support any future promotional claims. Consumer advocate organizations have urged the agency to require that multiple clinical trails be done on any advertised product, not just on its ingredients, to support advertising claims. However, such trials take many months, are very expensive, and are not required by current law allowing claims to be based on the body of science backing the active ingredients in a product. If the FTC and anti-business consumer advocates have their way, label claims and advertising will be far more restricted than is presently allowed. Of course, ads already have to be truthful and not misleading, so that’s not really an issue. But the FTC still wants more power so it can unilaterally impose a new regulatory scheme that bypasses today’s requirements for hearings, public comments, and due process before it can change the rules that we operate under.
Now the good news: despite strong efforts by certain committee members, the FTC provision has reportedly been stripped from the joint committee’s version of the bill. In other words, WE WON THIS BATTLE! For those of you who spoke up for our rights, thank you. But this was only one battle and industry critics have not given up on their crusade to over-regulate vitamins and other safe dietary supplements. It is still important to be ready for the next attempt to have the federal government take over the dietary supplement industry, as has been done in other countries where there are far fewer choices for consumers. .
Be prepared to tell your Senators and Representative in Congress that you want to continue to have access to safe dietary supplements and honest marketing claims without excessive government restrictions. Public action may be needed on short notice to head off tricky legislative maneuvering. Go to http://www.csofh.org/ to sign up for action alerts and learn how to Take Action! Protect your rights to have access to vitamins and stop the gov from taking control of everything you do.
New Bill Demands The FDA Enforce Dietary Supplement Health and Education Act
Wow it takes a bill to get the FDA to enforce an act? A new bill introduced on May 25 demands that the Food and Drug Administration (FDA; Washington, DC) implement the regulatory powers provided by the Dietary Supplement Health and Education Act (DSHEA) established in 1994. Called the Dietary Supplement Full Implementation and Enforcement Act of 2010 (DSFIE), the new bill has been introduced by Senators Orrin Hatch (R-UT), the original author of DSHEA, and Tom Harkin (D-IA). The bill also requires that FDA receive a minimum of $20 million in funding to aid enforcement. DSFIE was also a topic of discussion at a hearing held by the Senate Special Committee on Aging, last Wednesday.
A crucial part of the bill also asks FDA to finally establish clear guidelines for new dietary ingredients (NDIs). Without a process in place for companies to submit NDI notifications, and without a list of “grandfathered” ingredients allowed in dietary supplements, FDA has been hampered in its ability to enforce against dietary supplements that illegally contain unapproved substances.
Also along these lines, the bill asks that FDA and the Drug Enforcement Administration (DEA) communicate better to prevent anabolic steroids from being illegally marketed in dietary supplements.
As proof of increased enforcement action, the bill also requires FDA to annually report to Congress the number of dietary supplement manufacturers that have been inspected for GMPs, the number of NDI notifications it reviewed, and a summary of all enforcement actions taken in relation to dietary supplements, reported the American Herbal Products Association (AHPA; Silver Spring, MD).
What a noble quest, prevent consumers access to supplements that make them stronger but turn a blind eye and a fist full of dollars on the tobbaco industry.
FDA Warning For Natural Wellness that MasXtreme contains aildenafil
Natural Wellness and FDA notified consumers that MasXtreme, a product sold as a dietary supplement contains aildenafil close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile as well as the drug phentolamine which is an alpha-adrenergic blocker. This may pose a threat to consumers because aildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Common side effects of phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).
MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed nationwide by Natural Wellness Inc. Consumers who have purchased MasXtreme capsules are urged to immediately discontinue their use.