Reasons to doubt next FDA decision
SHARE
, / 262 0
FDA

FDA

How often do you reach for herbal supplements during day, week, month, year..? While considering it as doing a favor to your health or immune system, turning it into a substitute for the healthy diet you still haven’t started with. Or when was the last time you didn't feel comfortable with taking a generic drug, or just had no idea what it really meant? And when was the last time you felt like you have committed a crime after eating frozen pizza? Or is it just FDA having double standards when it comes to some things? Let’s start from the beginning.

Are you really taking what you think you’re taking?

Herbal supplements, when we multiply all the people taking them daily or monthly, with the prices they are paying for them, we get $5 billion worth industry. But, it becomes 5 billion dollars lie when the FDA does not take time to regulate supplements in these products. Not the same way they do regulate prescription drugs, what ends up like this: with herbal supplements you are not necessarily taking something you thought you were taking.
The latest study on the subject of herbal supplements, which we were able to read about in last few days, made us think about the FDA having double standards. The study made it obvious that we are often taking lie instead of memory boosters, mood enchanters, cold fighters or any other magical pill that comes from nature. Researchers in Canada reviewed 44 different herbal supplements; including all kinds of effect they should have on us and found out that one-third of them were nothing but substitutions. Consequence is that people end up taking something like wheat, rice or soybean and not what they think they do. Things become even more interesting when you find out that Ginko Bilboa, for instance, contains black walnut as substitute. This can become deadly for people with allergies to nuts. It’s not just nuts, 37 of them tested positive for hazardous substances such as arsenic, mercury, lead, cadmium and pesticides. So the conclusion people often make while taking herbal supplements; It can’t be harmful it’s just herbs, doesn’t seem to be true.
At the end “Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers,” researchers concluded in a study published in the journal BMC Medicine. While only two of the 12 companies had products without any, contamination, fillers or substitution.

FDA Double standards

Almost at the same time this week, when study was published, FDA came out with their latest news on requiring food markets to gradually phase out artificial trans fats. With the explanation that this plan could potentially prevent 20,000 heart attacks a year and 7,000 deaths. While trans fats are claimed to be artery-clogging ingredient number one. Everybody welcomes their idea; you definitely don’t need unnecessary harmful fats, especially eating them without being aware of it, but it has to make you wonder. How can they be so circumspective on one hand and not taking any proper care on the other, since its FDA’s decision not to have more strict rules when it comes to herbal supplements? Unlike other drug products, the Food and Drug Administration does not regulate dietary supplements with the same scrutiny it applies elsewhere. Supplement makers do not have to prove that their products are safe or effective to them.

New rule?

After reading all this, it might make you wonder when it comes to their latest news. Today’s news is that FDA has proposed a new rule which shall allow generic drug makers to independently update the safety information on their product labels, the same any brands do. Benefits of the new rule would be faster way of spreading the new information to health professionals and patients who use generic drugs. The new proposal suggests that generic drug makers can start the package inserts as soon as the FDA releases an announcement of any changes on the brand. On the other hand current process permits the generic drug makers to update their product labels only after the brand completes its update.
It’s basically a good thing, since generic drugs are identical or bioequivalent to a brand name drug in safety, strength, dosage form, route of administration, quality, performance characteristics and intended use. But the worry might accrue at the point you realize that FDA is increasing its independent decision-making domain, while at the same time they are obviously missing something about herbal supplements.

Register today to get full access to:

All articles | Magazine archives | Livestream events | Comments

PASSWORD RESET


Register today to get full access to:

All articles | Magazine archives | Livestream events | Comments

LOGIN