what does it mean when something is not FDA approved?

Question

I am currently taking these Biotin vitamins so that I can grow my hair faster and healthier. When I read the back of the box, it says that it is not FDA approved..what does this mean? Also, does Biotin really really work?

Answer 1

It means, it has not been approved by (FDA)Fools, Dolts and A****** !
Nothing to worry about if I was you :-) They usually don't approve anything which can actually make you feel better :-) ! But its better to make sure that the medicine is by an authentic manufacturer. Never gamble with your health please !
Take care and God Bless you !

Answer 2

It means that the United States Food and Drug Administration (Biotin is made by an American company called Solaray), has not given its certificate of approval for the claims that the vitamin will grow hair faster and healthier. Interestingly, some "vitamins" are not considered a "food" or a "drug" in the U.S. and therefore are exempt from having to be approved by the FDA. When a substance claims to change a person's health status, or have a cure for a disease, then the FDA steps in. Evidently, fast-growing, healthy hair is dubious, so the company felt they need to add the disclaimer. If the product said that it promoted "health-looking" hair, then there would be no need for the FDA to be mentioned on the bottle. Also, cosmetics, shampoos, lotions, and what-not do not have to be approved by the FDA. Whether Biotin works or not, I do not know. Probably not, or it would be a much more popular product.

Answer 3

Well - FDA stands for Food and Drug Administration.

Normally foods and drugs are tested by the FDA to determine that they are safe for human consumption. The testing is rigorous and time consuming but in general ensures that there are no dangerous side effects.

Anything labeled not FDA approved has not gone through the process of testing for safety... its possible beneficial or negative effects on humans have not been verified or tested.

And as far as I know, Biotin is just one of the many products that makes unproven and untested marketing claims in order to sell more product.

Just my .01

Answer 4

When any product says it is not FDA approved it means that the FDA does not think it is a safe product to use, but loopholes in certain laws allow unsafe products to slip through and find their way to consumer shelves. As for whether or not Biotin works, that I'm afraid I don't know.
*Note* FDA stands for "Food And Drug Administration"

Answer 5

FDA is the Federal Drug Administration. Drugs must be approved by them before they can be "on the shelves" to be sure they won't harm people. Also,all the "side effects are important for them to know. It used to take about 10 years or so of " experimenting, but they are approving drugs sooner these days. Meds like "Herbal vitiamins or supplements" are NOT controlled by the FDA so they don't approve them. The good news is: They don't Dis-approve them either! Just be sure your MD knows all the "drugs your taking...( even Herbal or Vitamins) in case of interactions ,allergies, etc.
Good Luck and Be safe!

Answer 6

It means that the substance cannot make medical claims, nor advertise it's use as a "cure."

FDA - the Food and Drug Administration - makes Drug Manufacturers prove that drugs are safe, do what they are prescribed for, and are made at specified quality levels.

It sounds like what you are taking is a "supplement," which is really just anything that a manufacturer puts together and sells, but for which no specific medical claims are made. Supplements are not regulated by the FDA - they fall into that grey area of "homeopathic" remedies.

Not having FDA approval means they can say whatever they want (usually things like "promotes," "helps," "aids in..." ) but they can't claim to CURE anything. It also means you have no recourse if the product is innefective "FOR YOU!"

Answer 7

FDA is governmental body that supposedly regulates what is safe for american consumption. If they are supposed to make sure the things we take are safe (as many of you believe) then what happened with Phen Phen (weight loss), Vioxx, Celebrex, antidepressants in children (hey, I'm not depressed anymore but I think I'll kill myself anyway!)? I don't know about you, but what the FDA thinks means very little to me these days. They approve one thing (and the stock holders make a lot of money, some of which are on the FDA or other government officials), then people die, then they say, WHOOPS, sorry, our bad, that wasn't safe afterall. Do your own research. Read the warning labels. Follow recommended dosages.

Answer 8

you have gotten a lot of good answers- and just to back them up-- the fact that vitamin C cures scurvy - this statement can't be written on a vit c package- because according to the FDA a Natural remedy can't Cure anything- it must be a prescription to Cure. Whatever!! this does not mean that your item will fix or cure you- every individual is different on how they respond to a Natural or prescription drug- research the Biotin and as long as it is safe for you - try it---(example- causes high blood pressure- and you already have a problem with it- do not take).

Answer 9

FDA stands for federal drug administration- it is the government agency that oversees the medications that are allowed on the market for our use by testing them and doing research.

You are foolish for taking something not approved for a superficial reason such as hair growth-- you have no idea what that chemical can do to you 5,10,15 years down the line or to your children.

Answer 10

IT MEANS THE GOVERNMENT HASN'T TAKEN CONTROL YET AND LETS THE CONSUMER USE HIS OR HER OWN JUDGMENT ON WHAT THEY WANT TO BUY! GUIDLINES MAY MAKE THINGS SAFER BUT IF THEY WERE THE ALL CONCLUSIVE ANSWER... WHY ARE THERE SO MANY E COLI EPISODES LATLY?