Filed under: FDA
The Food and Drug Administration (FDA) has issued a press release to consumers warning them about a counterfeit product being represented as the dietary supplement "ExtenZe.” The counterfeit product has hidden ingredients, including tadalafil or a combination of tadalafil and sildenafil, which are active ingredients of FDA-approved drugs, making these products unapproved drugs. Taking these products with prescription medications containing nitrates could lower blood pressure to dangerous levels. More information, including the lot numbers on the counterfeit packages, is provided in the FDA Press Release.
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to several companies selling unproven products claiming to treat, cure, and prevent sexually transmitted diseases (STDs). These products—such as Medavir, Herpaflor, Viruxo, C-Cure, and Never an Outbreak—violate federal law because the FDA has not evaluated them for safety and effectiveness. Some are marketed as dietary supplements, but the FDA considers them drugs since they are offered for the treatment of disease. More information is provided in the FDA Press Release.
The U.S. Food and Drug Administration (FDA) has information for consumers regarding dietary supplements: Questions and answers, regulations, and safety alerts. Click here for their website.
Red 40, Yellow 5, Yellow 6, and other dyes are artificial colorings allowed in foods in the U.S., yet there is a long-standing debate over whether food dyes contribute to hyperactivity in children. The Food and Drug Administration’s (FDA) Food Advisory Committee met the last week of March and determined that there is not enough evidence to support the link between food dyes and hyperactivity in children. For now, there will be no warning labels on food products containing dyes.
The Food and Drug Administration (FDA) has issued a warning about a vitamin solution, Soladek; samples that were tested contained dangerously high levels of vitamins A and D. The FDA has advised consumers currently using this product to stop immediately.
For more information, read the FDA warning.
Godi International, Corp., located in South Florida is announcing a recall of Fruta Planta weight loss dietary supplements because the products contain Sibutramine an undeclared drug ingredient. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Click below to access the recall alert.
In a report from the September 2010 issue of Consumer Reports®, the twelve most dangerous dietary supplements posing health risks have been identified. According to the report, these are dietary supplements which are taken by millions of Americans and have been found to cause serious health problems, including cardiovascular, liver, and kidney problems.
When you choose a multivitamin or supplement from the store, have you ever wondered how to choose? Or if there’s any regulation to ensure the one you choose is safe, and that you’re getting what you’re paying for? Regulation is perhaps the least understood aspect of the dietary supplement industry. We, here at HPRC, hope we can shed some light on the matter. Look for the quickest way to ensure quality and safety in your supplements at the end of the article.
Dietary supplements are regulated, but not as strictly as many might want. Oversight of dietary supplements began with the 1994 Dietary Supplement Health and Education Act (DSHEA). Since supplements are intended to supplement one’s diet, they are regulated the way food is, and not as drugs are. Under DSHEA, the U.S. Food and Drug Administration (FDA) regulates dietary supplements by holding manufacturers accountable in five important areas: Manufacturers are required to ensure that the supplement is safe; make truthful claims; abide by current Good Manufacturing Practices (cGMPs); submit to FDA all reports of serious adverse events, and notify FDA before it markets a supplement containing a “new dietary ingredient” (NDI).
What consumers should know is that manufacturers cannot sell unsafe, ineffective supplements; they have to document that their product will not harm anyone, and provide convincing evidence that the product does what it claims. To further ensure safety and effectiveness, the FDA closely regulates supplement labels for accuracy and honesty. All information on the label must be truthful and conform to all FDA standards. It has to list the sources of all components, and the amount of key nutrients and ingredients. Manufacturers are also required to report to the FDA before marketing supplements containing new dietary ingredients, which must have data supporting safety of the ingredient. The FDA also regulates manufacturing standards using the current Good Manufacturing Practices (cGMP) to ensure product quality and safety. Violation of cGMP is a violation of the law. Lastly, the FDA requires manufacturers to report on serious adverse events that may occur from consumers using their products.
Despite this oversight, there’s a misconception that dietary supplements are not regulated. This could be because supplements don’t require pre-market approval, and the post-market responsibility of FDA simply ensures compliance with the regulations listed above. The downside of this is that some unsafe and contaminated products end up on the market. Once there, the FDA has to prove that the product is unsafe (or show that the information on its label is untruthful or misleading), before it can be removed from the market. Also, although supplement labels are highly regulated, the content of separate brochures and fliers is not subject to FDA rules.
Enforcing regulations take time and resources. Since the cGMP rule went into effect in June 2008, the FDA has conducted approximately 55 inspections for compliance with the new regulations – and in light of the thousands of companies manufacturing supplements, there’s some dissatisfaction with the progress of the FDA.
So how can you protect yourself, as a consumer, from ineffective or even potentially unsafe supplements? There’s a simple answer: When purchasing dietary supplements, choose products approved by independent organizations that offer certification or verification. Look for supplements whose labels display a seal from the United States Pharmacopeia (USP), the non-profit NSF International, or the Natural Products Association (NPA). Since these verifications are voluntary and are performed at the company’s expense, you can be certain that approved products have little or no contaminants, that the ingredients are present in the labeled amounts, and the labels are accurate.
The FDA does not strictly regulate dietary supplements. As a result, supplements may not be as pure as stated on the label and may have potentially harmful contaminants. When purchasing dietary supplements, choose products approved by United States Pharmacopeia (USP) or other reputable sources.