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Recent FDA questions
Do the US customs officials look the other way on all dugs
Do the US customs officials look the other way on all dugs other than illegal drugs of course I figure Opiates and things like Amphetamines along with Steroids don't get the 90 day personal use treatment but if I had a prescription from my Dr would importing Human Growth Hormone in small amounts get through customs? I wouldn't even try without a script but its so expensive that nobody can afford it. Thank you?
To socrateaser, only. The very successful dietary supplement
To socrateaser, only.The very successful dietary supplement brand Drs Best Vitamins has been around for at least a decade so I'm certain they'd be experts with FDA and FTC compliance but I noticed they have a scientific fact sheet webpage http://www.drbvitamins.com/learn/scientific-fact-sheets/ which leads to a pdf sheet that endorses each of their used ingredients with medical journal references and is plastered with their own company logo and product so it's an obvious endorsement. Does this represent a loophole I'm not seeing?
If I've taken a drug that recently became FDA approved
Hi,If I've taken a drug that recently became FDA approved (July 2015) and experienced a profound and possibly permanent side effect that is ongoing even after I've stopped the drug, and that side effect, while not listed at all on the FDA label for the drug, is listed on the EMA label (European Medicines Agency), do I have a legal case against the drug maker?
Hypothetical scenario = Australian company (ACN) has dietary
Hypothetical scenario = Australian company (ACN) has dietary supplements manufactured in USA to sell onlineReading through the FDA and FTC official websites, any statements which imply a supplement effects a disease, effects therapy or effects the body's response are a violation. Claims, implicit or implied, citing journal studies are only adequately substantiated based on specified criteria. FDA has jurisdiction over the label and FTC has jurisdiction over advertising.How can findings within research papers be collaboratively presented for genuine informative interest and value and in no way be condemned by the FDA or FTC as an implied representation of conclusive evidence of cause and effect or even authoritative association.For example:“Chondroitin supplementation improved hand function in patients suffering symptomatic osteoarthritis with reduced hand pain and morning stiffness, in a 162 patient, randomized, double-blind, placebo-controlled clinical trial (Gabay et al).Arthritis & Rheumatism. 2011 Nov; 63(11):3383-91. Symptomatic effects of chondroitin 4 and chondroitin 6 sulfate on hand osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial at a single center. Gabay C, Medinger-Sadowski C, Gascon D, Kolo F, Finckh A.”It is clear that if the bold print were on a label is violates FDA regulations. If this were on the same webpage as a dietary supplement, it violates FTC regulations.But, the cited information is still valid and relevant material. Such material exists and is publicly accessible. How is it not helpful to make such knowledge more available to those who would be most interested and most inclined to seek out the already existent information? Is there any way it can be incorporated into a dietary supplement website without violating FDA or FTC regulations?
I had a bad reaction to lyrica including severe depression
I had a bad reaction to lyrica including severe depression and anxiety. I was hospitalized, treated by a psychiatrist and underwent ECT treatments. I finally recovered after discontinuing the lyrica. I filed a report with the FDA in February of 2015. I'm unsure whether I should seek advice from a lawyer.
My question is about the legal issues regarding selling
My question is about the legal issues regarding selling products containing substances commonly known as "research chemicals" that are similar to controlled substances, but not Schedule I or II drugs and therefore, by my understanding not subject to the federal Analog Act. Take for example, a thienobenzodiazepine which acts similarly to a benzodiazepine, and an actual benzodiazepine, in the situation where neither compound is particularly enumerated in federal or your particular state law. What would be the legal issues surrounding the sell of such? And would it be different in any way for the thienobenzodiazepine from the actual benzodiazepine? Also would it be different for a novel drug that was essentially unrelated to any scheduled drug? If so, what would those differences be? As an example of a specific issue, would the labeling of the drug as "not for human consumption" be relevant? From what I understand that is commonly used as a method to attempt to avoid the federal analog law. But I also suspect that it might still have implications in the sell of products not subject to the federal analog law. I'm sure there have to be some laws and regulations regarding the sale of non-FDA approved products for human consumption, I just don't know what they are. And I suspect regulations are less restrictive when labeling something as not for human consumption? Though I also suspect simply labeling something as not for human consumption would not fully protect a merchant selling a product containing a well known so-called "research chemical" such as a benzodiazepine analog? So I guess my specific question in regard to the labeling issue is, would labelling a product containing a thienzobenzodepine or a benzodiazepine analog as "not for human consumption" have any bearing on the laws and regulations involved in selling it? And where would I find the laws and regulations for such? I know for certain it's legal to possess such a substance, but I'm equally certain there has to be some kind of regulations regarding selling it, I just don't what they are, so that's what I'm looking for help with. Thanks so much.
I just watched 60 minutes and the story was about Lumber
I just watched 60 minutes and the story was about Lumber Liquidators flooring from China which has very high level of formaldehide. I think our flooring may fall into that set and I just finished bilateral breast cancer treatment. It is Mayflower HS SundanceBirch from China.
My question is regarding the use of the word "organics" onView more consumer protection law questions
My question is regarding the use of the word "organics" on the labels of my skincare line.My products use natural and organic ingredients. However, the organic ingredients themselves are not certified organic.USDA and FDA regulations are confusing.Can I, or can I not, use the word "organics" in the name of my products and/or the name of my brand?