Is vitamin D3 (cholecalciferol) FDA approved for crohn's ?

new studies confirm that vitamin D is a potent immune modulator and has a promising future in autoimmune disease as crohn's , but is it FDA approved?

3 Answers

  • 1 decade ago
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    Technically, the FDA doesn't approve or deny any supplements aside from general vitamins and minerals (those that have an RDA), so they aren't "approved". Vitamin D is recommended for daily intake (since it has an RDA) and the FDA and doctors generally recommend a multivitamin with Vitamin D, but it's not "approved to treat Crohn's Disease" since the FDA won't approve any supplement to treat any disease or ailment (there are many theories to why, but I won't get into that). But if it was "FDA denied" (eg. contaminated product, bottles not containing the right product, etc), it's removed from the market and/or the company making it gets shuts down.

    It's already happened a number of times... one of the biggest cases I can think of is when they banned Tryptophan for around a decade because of a contaminated batch that some people died from. It was banned that long because of misinformation that came up about it and partially from media coverage that spread that got some people thinking that it was the supplement, not the company.

    With all that being said, there actually are watchgroups and organizations that do regulate supplements and regularly report to the FDA for any major adverse reactions (and the supplement companies that sell them are supposed to report these as well). The GMP (Good Manufacturing Practices) and USP (U.S. Pharmacopoeia) are the main quality assurance organizations (USP is for the U.S., GMP is for the U.S. and worldwide).

    The best thing you can do when buying a supplement from a company is to call the company and ask them to prove their quality. No, not just ask if they have good quality, but ask them to prove it. Their products should be tested/reviewed by independent 3nd party companies to verify their quality and they should be able to prove it rather easily. If they can't prove it, I wouldn't use their products... it's your responsibility to know what you're buying and to make sure the company you're getting it from is good.

    Good luck and I hope I helped!

    Source(s): Personal research in my role as a Product Specialist for a vitamin company
  • 4 years ago

    Well, it's a vitamin. You can buy it over the counter with no prescription to take as a nutritional supplement. It is approved as a nutritional supplement. You don't need any disease to take a nutritional supplement. I'm not sure what you mean by "is it approved for crohn's"? A person with crohn's could certainly walk into a drugstore and buy some d3 and take it as a nutritional supplement. Usually when we talk about what a drug is approved for we're talking about prescription medication and whether it is used for its FDA approved purpose or "off-label" for something else. You can't really use a regular vitamin (like d3) "off label". If you take d3 you are taking it as a vitamin supplement. If it helps with a person's Crohn's then that is because the person is lacking in vitamin d3. Perhaps Crohn's is related to d3 deficiency. I don't know if it is or not but if d3 helps then it must be because of a deficiency of some sort.

  • 1 decade ago

    Crohn's can be controlled through diet. Each person with the disease will react differently to different foods. One of the best ways to see what works (and what doesn't work) for an individual is to keep a comprehensive food diary for several months. Every morsel and drop must be recorded because then it's possible to go back and link a Crohn's flare up to food or drink.

    Although there are those who will disagree, I found the best way to control Crohn's was to become a vegetarian. Apparently I have difficulty digesting some proteins and meats in particular are a problem. I also have difficulty with some fruits, notably rhubarb and apples. And about a decade ago I had to stop drining coffee although tea is not a problem.

    But each case is different which is why it's so important to keep an exacting food diary.

    Source(s): Personal experience
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