Saturday, July 22, 2017
Coffee with a 'Viagra-like' ingredient was just recalled, and it reveals a bigger problem
The ingredient is increasingly being used in supplements claiming to have "male enhancement" properties. While some limited evidence suggests that taking a specific tongkat ali supplement can improve the quality and concentration of sperm in infertile men, there is little evidence to support its use for erectile dysfunction, athletic performance, or low testosterone.
The ingredient can also have dangerous side effects, which is why it's important for people to know what they are consuming.
According to the FDA, desmethyl carbodenafil can interact negatively with some prescription drugs by lowering blood pressure to dangerous levels. Men who have diabetes, high blood pressure, high cholesterol, or heart disease are at particular risk.
The 'proprietary blend' loophole
To illustrate the problems plaguing the supplement industry, Cohen likes to compare the safety framework for supplements with the one we have for food.
Ingredients in food products have to meet a guideline known as the "generally recognized as safe," or GRAS, standard. Ingredients introduced to supplements do not.
There are some laws regulating dietary supplements, however. In 1994, Congress passed the Dietary Supplement Health and Education Act to address the labeling and safety of supplements. Several more recent regulations mandate that manufacturers observe what is known as "good manufacturing practices," including ingredient testing.
But Cohen said those regulations are "not anywhere near the level of scrutiny" applied to food. A PBS Frontline investigation even found that the DSHEA received investments from many players in the supplement industry.
Under the DSHEA, manufacturers that list ingredients under the "proprietary blend" category don't have to note the amounts of individual items in that category. Instead, they only have to list the ingredients within the blend and the total amount of it. But certain ingredients are still often left out or mislabeled — either intentionally or not.
The act also allows supplement makers to claim their products do things they may not — so long as it says somewhere on the package that they are "not intended to treat, diagnose, prevent, or cure diseases."
If a product is unsafe, then, it becomes the FDA's responsibility to prove it, and supplements as a whole are subject to far less investigation than other products.
"From a regulatory perspective," Cohen said, all of these supplements "are presumed to be safe, but the reality is many people ... are harmed."
Source: businessinsider.com
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