Questions tagged [fda]

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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 ...
imrobert's user avatar
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2 votes
1 answer
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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 ...
J. Taylor's user avatar
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Does FDA require Clinical Research Companies/labs required to use relational/non-relational databases to store or document clinical trial data?

Are American Clinical Research Companies or laboratories doing analysis for clinical trials required to use relational databases or non-relational databases or Relational Database Management Systems ...
Coo's user avatar
  • 315
5 votes
1 answer
988 views

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?
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2 votes
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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 ...
Patrick's user avatar
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3 votes
1 answer
109 views

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 ...
JustBeingHelpful's user avatar
1 vote
1 answer
59 views

How to interpret the US law for Emergency Use Authorization

Does the list of requirements in this law below mean that the Secretary must follow all requirements to satisfy the EUA or it's up to the secretary which ones are required? https://uscode.house.gov/...
user713813's user avatar
1 vote
1 answer
151 views

Is it legal to sell food or supplement products online in unlabeled packaging?

As I understand it, the FDA requires labeling with specific information for food and supplement products in most cases, and steep potential penalties for "misbranding" if required ...
LPG's user avatar
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1 vote
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Can an employer mandate an EUA-approved vaccine?

Liberal political commentator Matt Yglesias just tweeted this: I’m not an expert in Vaccine Law. But the military requires a lot of vaccinations but says it can’t require the Covid vaccines because ...
Keshav Srinivasan's user avatar
1 vote
1 answer
95 views

Can the need for FDA authorization of a tool to find infectious people be bypassed by labeling?

Background. OTC (over-the-counter, i.e. not requiring a prescription) rapid antigen covid-19 tests are the tests which detect pieces of viral proteins using lateral flow paper strips. Infected ...
fiktor's user avatar
  • 113
-1 votes
1 answer
582 views

Why is it difficult to import 5-HTP (a form of Tryptophan) into some countries? [closed]

5-Hydroxytryptophan(WP) is sold in various places around the world as a dietary supplement that may boost serotonin levels, with possible benefits as a sleep aid, antidepressant, appetite suppressant, ...
i336_'s user avatar
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0 votes
1 answer
163 views

Can POTUS make FDA approve a drug (such as hydroxychloroquine), or make it available over the counter?

President Trump is known to have taken hydroxychloroquine (HCQ) as a prophylactic against COVID-19. Some prominent medical scientists also came out in support of HCQ for outpatients (as opposed to ...
MWB's user avatar
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3 votes
0 answers
75 views

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, ...
ZenTangle's user avatar
1 vote
2 answers
196 views

What are my rights and proper actions if the food contains traces of household chemicals?

I recently bought a juice from the supermarket. That specific type of juice is probably produced in that supermarket locally. After trying it, I am reasonably confident that it contains soap. For the ...
random's user avatar
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0 votes
1 answer
112 views

At what point does a local garden produce exchange run into legal barriers?

I have an idea for a local garden produce exchange. Assuming two neighbors swapping lettuce has zero legal restrictions, at what point would we run into legal barriers while expanding in the ways ...
hamboy's user avatar
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-2 votes
1 answer
323 views

How do fast food chains get away with selling fake chicken?

Subway chicken only about 50% meat, according to Canadian study What's in your chicken sandwich? (Subway's "chicken" is 50% chicken, and Wendy's is 88%. The rest is non-meat additives) Subway ...
MWB's user avatar
  • 1,294
2 votes
1 answer
185 views

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 ...
User2112's user avatar
0 votes
1 answer
119 views

Is it legal to sell gases for human consumption (as supplements or otherwise) such as oxygen, nitrogen, or nitrous oxide

This question is based on the FDA's Federal Food, Drug, and Cosmetic Act, where they list medical gases as being regulated by the FDA. There is ambiguity, however, as the act puts an emphasis on high ...
riAToNdH's user avatar
1 vote
1 answer
139 views

Questioning the meat served at a local restaurant

I ate at a buffet which allowed me to take out my food and the meat supposed to be chicken tandoori. I got a piece of chicken that I thought was a thigh but when I tried to bite into it the bone ...
user21195's user avatar
4 votes
1 answer
523 views

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 ...
user avatar
2 votes
1 answer
832 views

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 ...
Keshav Srinivasan's user avatar
3 votes
1 answer
203 views

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 ...
Sidney's user avatar
  • 323
7 votes
1 answer
846 views

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 ...
jqning's user avatar
  • 8,667
2 votes
0 answers
118 views

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, ...
ratchet freak's user avatar