When does something become a medicine and therefore only be sold by lisenced persons?

Question

For example VIt c could be classed as medicine as it could be used to prevent the disease of scruvy. Also all food could be classed as medicine as it is used to prevent various dis-eases - like death, surely death is the greatest disease there is? What about sugar for preventing the disease of low blood sugar?? Why don't these things have to be lisenced through expensive tests, when, very soon, 5htp and ldopa will. What right do they have to be so hipocritical?? I really hate this government, the way they choose what is and what isn't a medcine annoys me becuase EVERY food can be classed as a medicine! They should have no rights to be able to tell us what is and what isn't a medicine, when they don't do it conisistantly and they don't axactly provduce safe medicines themselfs!!!!!!!!!! I really need a good answer here, please think carefully before answering

Answer 1

The US Food, Drug, and Cosmetics Act (section 201 et seq) defines drugs as "articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease ... or to affect the structure or any function of the body..."   Yah, that's not much help.  It gets worse.  Food is defined as "articles used for food..." and goes on to specifically include chewing gum.  State pharmaceutical laws aren't much different.

Congress probably left these definitions uselessly vague to give the FDA flexible power to adjust to changing food and drug realities--and they change so fast that the regulations and decisions made today might be different tomorrow.   The reality, as your frustration reflects, is that the decisions reflect power, legal muscle, and mainstream practice.

One clue that the statutory definitions provide is that what is a drug or food seems to depend on its intended use, not it's potential use.  Beet juice could be used as house paint, but if it's intended as food, I guess it's food.  If it's intended to paint houses, I guess it's paint.  If it's sold as a remedy, I guess it's a drug.  Most of the controversey about what food is relates to labelling (the FDA has a whole website section devoted to that topic) and claims made by sellers--a concern that's not unreasonable.

5htp, I guess, is found naturally in many sophisticated herbal remedies.  My favorite herbalist didn't know what Idopa is, and neither do I.  Is the FDA planning to regulate the sale of herbs and spices that happen to contain 5htp?  Or merely to regulate the sale of such substances when sold with the name "5htp" or in some other way suggesting that they be used medicinally?

An apple a day, says the say, keeps the doctor away.  But just to be safe, apples ain't sold that way.  Health claims made on cereal boxes might actually provoke FDA action--and until they do, you're right.  The FDA is being hypocritical.

You're not alone in wondering how the FDA defines food.  The first page of searches I tried brought up when your Q caught my eye had eleven hits, and three were from federal agencies complaining that  FDA does not define food clearly.  One was from Homeland Security.

The political wrangling involved in getting an enforcible definition would probably cost far more than the pricey tests for any single product.  Given the weak political and financial position of alternative medicine, a consistent ruling might outlaw alternative practice altogether.  Maybe hypocrisy isn't the worst it could get.  Benign neglect is under-rated.

What right do they have?  It's the one Mark Twain warned us about when he noted that no man's life, liverty, or property is safe so long as the legislature is in session.   You've got nothing but sympathy from this ol' libertarian fogey.

Answer 2

It's a long process to get approved by the FDA.  You have to prove that the drug is both safe and EFFECTIVE.  In other words, you can sell over the counter herbals that don't do anything to help a disease state.  But, as long as it's classed as a food, they don't have to prove that it works.

The company who makes a product decides if they want it to be a medicine.  They would have to pay in the millions of dollars, so most of them leave products classed as foods.  But really, if something worked great, a drug company would patent the chemical structure and get it licensed as a drug.

Answer 3

Things like common foodstuffs do not need to be approved by FDA bacause they have been in use for a very, very long time. Some old medicines, like aspirin, did not go through the approval process either, as there was no such approval process in place when they were first marketed