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Questions tagged [fda]

28 questions
7
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1 answer

Do milk crates have registered owners?

Is there an actual milk crate registration system? What is the law by which use by other than the registered owner is punishable? Is there an index I can use to see who these milk crates are registered to? Where can I register my milk crates to…
jqning
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1 answer

Does FDA's "compassionate use" program allow doctors to prescribe drugs to themselves under Emergency Use?

Does the "compassionate use" program allow doctors to prescribe drugs for themselves that have been approved under an FDA emergency use authorization?
user46398
5
votes
1 answer

FDA regulation of end user non-medical software

Does the FDA have any regulations limiting the installation of non medical software by an end user on to an approved regulated medical device? This is in relation to https://law.stackexchange.com/a/103990/31989 where it was mentioned that use in a…
user1937198
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4
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Can a US state ban a drug that is approved by the FDA?

The more common scenario nowadays is for a US state to "legalize" a drug that is illegal Federally, namely cannabis. This scenario has been well-researched and it is well-settled that the superiority of Federal law ensures that cannabis remains…
Robert Columbia
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4
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Cream cheese is cheese?

For legal purposes in the US, is cream cheese considered "cheese"? Who regulates this and what definitions do they give? If someone is contractually obligated to provide cheese and they provide cream cheese, is that acceptable under the law?
user18924
3
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1 answer

Safety and effectiveness have not been established for _

If an FDA approval says the following for treatment with a medical device, does this mean a doctor absolutely cannot treat a patient (with any of the conditions) with the device? Or does it just mean be cautious? "Safety and effectiveness have not…
JustBeingHelpful
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3
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1 answer

Why does the FDA prevent the sale of health reports that may affect a diagnosis or treatment plan to consumers?

So I was reading an interesting article from MSN how a company can now map your genome for a relatively small fee. It mentions something confusing, that being that [...] the FDA restricts direct sales of health reports to consumers that have the…
Sidney
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3
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Does the FDA have authority to regulate medical devices which aren't marketed?

I'd like to know if there is anything in US law that gives the FDA authority over medical devices which aren't marketed; and where that is in the law specifically. I did a quick search of Title 21, Chapter 9 (the FD&C Act) but couldn't find a…
ZenTangle
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What determines the legality of whether a non-controlled substance can be included in food?

If there was a food or chemical substance that was not listed as a controlled substance either federally or at the state level, and it is never explicitly mentioned in any FDA food guidelines, does that mean that it can be included in food and sold…
J. Taylor
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2
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How are food products containing partially hydrogenated oils (PHOs) still being sold?

All food products containing partially hydrogenated oils (PHOs) were banned from being sold in stores in the US starting January 1st, 2021: To allow for time for reformulation, the agency is extending until June 18, 2019 the compliance date to stop…
Patrick
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2
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Does the prize in cereal violate the non edible restriction in foods?

In the US the FDA has a regulation that bans toys or trinkets embedded in candy. This let to banning the Kinder Surprise egg in the US Does this regulation also cover the prises in cereal? If not, what regulates those choking hazards?
ratchet freak
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2
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Would it be legal for a diabetic person to extract and use insulin from pig pancrea?

Ignoring all considerations of efficiency and possibility, would the FDA restrict a diabetic person from buying slaughterhouse scraps (pancrea), extracting insulin from them, and using that insulin to regulate their blood glucose levels? Are there…
User2112
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1 answer

Is it illegal for a consumer to obtain or use a non-FDA approved medical device?

The Freestyle Libre Pro, which is a continuous glucose monitoring (CGM) system, was approved in September 2016 for use by healthcare professionals has not yet been approved for use by consumers, as described in this press release: ABBOTT RECEIVES…
Keshav Srinivasan
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What is the correct ingredient labeling order for cosmetics to comply with the FDA?

On 21 CFR 701.3, FDA Summary of Cosmetics Labeling Requirements, Declaration of Ingredients, it states that "ingredients must be declared in descending order of predominance." What is the definition of predominance as it is used here? In food…
CubicInfinity
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Can I sell an unscheduled compound as a recreational drug in the USA?

From the Oxilofrine Wikipedia page: Legal Status US: Unapproved "New Drug" (as defined by 21 U.S. Code § 321(p)(1)). Use in dietary supplements, food, or medicine is unlawful; otherwise uncontrolled. Does this mean I can sell oxilofrine as…
imrobert
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