I am creating my own dietary supplement products. The
I am creating my own dietary supplement products. The products will be sold in their individual carton boxes. The question is this: Since the product bottle is very very small I have very limited space on it. Therefore, I am wondering if I can eliminate some of the information and use them just on the outer box such as nutritional panel, some claims. Thanks
I have Interstial cystitis, am 61, after years of doing
I have Interstial cystitis , am 61 , after years of doing painful treatments without success My PCp and I made the difficult decision that I needed to take a moderate dose of a narcotic as we had exhausted all other possibilities and recommendations of specialists . My Pcp has retired and the new Doctor I have been assigned to had her medical assistant call me to tell me they would no longer pjrescribe my pain meds . I have never abused my meds never failed a urune test or a pill count never been in trouble with the law ever . I work part time as a psyche nurse . This new Doctor has not looked at my paper chart and has not even met me yet . I am vigilant about checking for new treatments for my illness and there is nothing out there except what I have already tried . I cannot afford to be ill and loose my job at this point in my life . My pain is manageable on my present meds which are very safe. I have suffered since I was twenty with this horrible illness and finally I had found a balance and now my quality of life is being taken away from me with no hope of finding any thing else that will help . My dose is well below the new Maine law and I did read the CDC recommendations and they do make " room for using opioids as part of a comprehensive plan " I am on a special diet , I excercise daily , I do not smoke never did , I drink a glass a wine very rarely ,I do electrical stimulation at home and also do ultrasound and massage . I did some acupuncture but my insurance does not cover it and I cannot afford it . Please help . I am facing a total loss of my quality of life, loss of my job and eventually loss of my home .. Disability would be difficult as I have been working and there is a proven treatment that works ! forJA: Because real estate law varies from place to place, can you tell me what state this is in?Customer: Maine - this is not a real estate issue !JA: Has anything been filed or reported?Customer: No I see this new Doctor I was assigned to in the practice next week but I was pre warned by phone that she will not prescribe my narcotic anymore .The medical assistant on the phone admitted they did not have my paper chart , they have limited info on their new electronic record .. The assistant also said I was taking med for osteoporosis which is wrong . I insisted I needed the Doctor to read my paper chart . The assistant called me back and said the Doctor said I needed to see a urologist and I then asked her again if my chart had been looked at and she said no it had not gotten there yet . I then told her that the Doctor will see in my paper chart when reads it that I have seen multiple urologists and had ecxhausted all treatment recommendations ! I insisted they book an appt for me with this new Doctor assigned to me in the practice . They did give me an appt . I have been on theJA: Anything else you want the lawyer to know before I connect you?Customer: is this a free consultation ?JA: The Lawyer's require payment for their services. It's way less expensive on JustAnswer than face-to-face would cost.Customer: Am confused as you said above real estate law ! Will I be speaking with a lawyer that has experience with patient rights issues .
I've got a startup that sells supplements online - an
I've got a startup that sells supplements online - an "e-commerce supplement company" And am wondering 1. what are some generic warnings/disclaimers that are necessary to 'cover my ass'? 2. should i have supplement-specific warnings as well? cheers!
I'm a food labeling compliance specialist and I'm trying to
Hi Pearl.... I'm a food labeling compliance specialist and I'm trying to find where the FDA allows for herb ingredients in a product to be listed as "herbs" instead of spices (as per 21cfr101.22). Do you have any insight?JA: Have you contacted the seller or manufacturer? What documentation do you have?Customer: I have the list of ingredients for the "herbs" and the ingredient does only contain herbs: cumin, oregano, thyme, and rosemaryJA: Because laws vary based on location, what state are you in?Customer: FloridaJA: Anything else you want the lawyer to know before I connect you?Customer: nope
I ams tarting a new business in USA. Importing some pickles
Hello Sir/Madam,I ams tarting a new business in USA. Importing some pickles from India to USA and selling them here over internet.The pickles are made from Vegetables, shrimp, goat meat, chicken.My questions are:1. Do I need Govt of USA permissions to import those?2. Do I need to meet US FDA food and dieteray regulations? If yes what is the process? How much money it costs?Thanks
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?