Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?
[Posted on: Thursday, 21 April , 2016] Almost every week FDA make public announcements about dietary supplements with risky ingredients such as unapproved drugs, hidden drug ingredients, dangerous chemicals and other ingredients. FDA’s web-site lists more than 700 such dietary supplements that are sold in the US market. The list is published based on tests conducted at FDA’s labs. However, very few retailers and distributors of such dietary supplements are penalized despite laws that exist to do the same. About 10 Warning Letters are issued each year for dietary supplement related issues, but very few people have faced monetary fined or subjected to criminal prosecution for selling potentially harmful products. In 2015, about 126 public notifications for harmful dietary supplements were released while only 12 Warning Letters were issued; no other actions seems to have been taken against the violators. In several cases, it seems that the violators simply changed names of the products, rebranded and came right back to the market. Even the FDA list starts with a somber disclaimer that list only includes a small fraction of the potentially hazardous products marketed to US consumers on the internet and in retail establishments. It acknowledges that FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. It pretty much leaves it to the consumer to exercise caution before using dietary supplements. FDA has been frequently accused of inadequate regulation of the $33 billion dollar per year supplement industry with more than 40,000 products in the market. The risk of dietary supplements was pushed to national news last Oct when a former basket ball player Lamar Odom went into coma after apparently consuming dietary supplements. Incidentally, FDA had issued a public notification for the same supplement in 2013, about 2 years before the incidence indicating that it had no effect on the sale of the same dietary supplement at this retailer. After the incidence, the retailer and distributor were not even given a Warning Letter by FDA. For all we know, they are probably still selling the supplement. The picture is pretty gloomy. Consumers need to pay more attention to what they consume. If it claims to be treat a disease ask why it was not approved by the FDA; if it seems too good to be true, it most likely is. One would think that regulating dietary supplements should be the low-hanging-fruit for regulators; they can easily controlled by just controlling their labels. Still we find so-called supplements claiming to treat diseases such as obesity, cancer and neurological indications openly on their labels and even in mass media and social media. Clearly FDA is not interested or capable or protecting consumers for all dangerous dietary supplements. May be I am too harsh but facts are hard to swallow. Buyers beware.
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