2gypsies Posted December 16, 2020 Report Share Posted December 16, 2020 The FDA has nothing to do with home remedies and supplements. Full-timed for 16 YearsTraveled 8 yr in a 2004 Newmar Dutch Star 40' Motorhome and 8 yr in a 33' Travel Supreme 5th Wheel Link to comment Share on other sites More sharing options...
JimK Posted December 16, 2020 Report Share Posted December 16, 2020 3 hours ago, 2gypsies said: The FDA has nothing to do with home remedies and supplements. Food and drug.... The FDA is responsible for the food supply. That would include dietary supplements. Remedies such as snake oil are under the purview of the FDA. Any claim to diagnose or treat any disease is covered by their mandate. My point is FDA is worthless in this regard. https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate Foods, including: dietary supplements bottled water food additives infant formulas other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products) Drugs, including: prescription drugs (both brand-name and generic) non-prescription (over-the-counter) drugs etc................................ Link to comment Share on other sites More sharing options...
JimK Posted December 16, 2020 Report Share Posted December 16, 2020 3 hours ago, Kirk W said: Me too. The FDA has nothing to do with cosmetics and that is what it is listed as. I did an FDA drug search and caimon oil isn't there. Did you read the claims for caimon oil? The claims included TREATMENT for a host of DISEASES including: acne, age spots, burns, scalds, dandruff, eczema, joint pain, muscle pain, MRSA infections and nail fungus. Those are medical claims that need approval by the FDA, whether prescription or over the counter. Again, the FDA is worthless in carrying out a majority of its responsibilities. Visit a nutrition store, read the "health" mags, look at the claims on supplements. You will often see: not approved by the FDA for the diagnosis or treatment of disease. But they still make the claims. Since the FDA does nothing the situation has gotten way out of hand and blatant. In addition, you are absolutely wrong. The FDA does indeed regulate the safety of cosmetics. Link to comment Share on other sites More sharing options...
bruce t Posted December 16, 2020 Report Share Posted December 16, 2020 Australia's flu cases this season have been mentioned above. For what it's worth Australia, in the period Jan to Jun 2020, there were 'just' 36 flu deaths. (Remember that's our fall winter period). The same period last year was 430 flu deaths. The 'theory' being that folks are taking a more cautious approach to hand washing, social distancing and the wearing of masks where close contact was unavoidable. It can therefor be argued that 394 lives have been saved by covid-19. (It would be interesting to do a similar calculation for the USA). The point is that commons sense actions by individuals can save lives. While Australia has 'only' had 908 covid deaths the precautions have saved 394 flu deaths. (Over 800 of Australia's covid deaths are from one avoidable breakout). That's a net increase in deaths for the year based on just covid and flu statistics. It's easy to blame politics, governments and authorities for the covid-19 worries. But Australia is a prime example of how individuals make the difference. (I must add that 'individuals' in some cases were steered by government regulations and laws. Something I can't imagine happening in the USA). Wash your hands. Keep your distance. And wear a mask when in close contact with others. FWIW Australia is all but back to 'normal'. Yes hard laws with state border closures have been a PITA. But look where we are now. Stay safe. Link to comment Share on other sites More sharing options...
2gypsies Posted December 16, 2020 Report Share Posted December 16, 2020 1 hour ago, JimK said: Food and drug.... The FDA is responsible for the food supply. That would include dietary supplements. Remedies such as snake oil are under the purview of the FDA. Any claim to diagnose or treat any disease is covered by their mandate. Unfortunately, you didn't capture the full description of the topics. .... "But not all those products undergo premarket approval — that is, a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA’s enforcement efforts focus on products after they are already for sale." .... "Although FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in foods. Those include food additives, such as substances added intentionally to food, and color additives...." .... "Cosmetic products and ingredients, and their labeling, do not require FDA approval before they go on the market. There’s one exception: color additives (other than coal-tar hair dyes). .... "Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness." .... "Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease." Here is the complete article: https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved Full-timed for 16 YearsTraveled 8 yr in a 2004 Newmar Dutch Star 40' Motorhome and 8 yr in a 33' Travel Supreme 5th Wheel Link to comment Share on other sites More sharing options...
JimK Posted December 16, 2020 Report Share Posted December 16, 2020 (edited) 6 hours ago, 2gypsies said: Unfortunately, you didn't capture the full description of the topics. .... "But not all those products undergo premarket approval — .... "Cosmetic products and ingredients, and their labeling, do not require FDA approval before they go on the market. .... "Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness." .... "Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease." As far as I am concerned these statements reflect on the poor oversight of the FDA. The FDA is absolutely responsible for the safety of cosmetics and food additives, for approval, efficacy and safety of any medical claims. Yet they have chosen not to even bother with premarket approval for many products and seem to avoid any involvement when it comes to food additives, supplements or medical claims for OTC drugs even after those products are on the market. This lack of action and concern is very evident and the FDA has totally failed to bother with extensive medical claims for the worst of the snake oils. It is very common for companies to make all sorts of medical claims. There is all sorts of nonsense about antioxidants and free radicals for example. The FDA does nothing to halt these claims or to even ask for documentation. Some well hidden disclaimer about "not intended" is just worthless and does nothing. The FDA is still responsible and has the legal authority to assure the public that these claims are valid. In addition to observing the inactivity, I spent a year working at the FDA, National Center for Toxicological Research. The NCTR is great for spending money and studying the theories of toxicological research but does not evaluate any products, ever. The FDA is also responsible for cosmetics, food supplements, drugs, and medical devices made outside the US. The amount of oversight has been extremely minimal and in March of last year the FDA suspended any inspections of overseas facilities. This discussion has nothing to do with the Covid vaccines, except that the FDA has done a near worthless job with food additives, supplements and OTC drugs and devices. I have also worked with many FDA approved medical devices that were defective. Until I realized I was wasting my time, I also filed numerous whistle blower complaints regarding defective products. Those complaints included the documentation of the defects. No, I do not trust the FDA at all. They have failed to show even minimal concern or action for most of the issues for which they are mandated by the food and drug laws. Finally let us not forget the abysmal failure of the FDA to look at Covid test kits. They literally opened the door and permitted marketing of any Covid kits with absolutely no oversight. It took Roche Diagnostics filing complaints and press releases for the FDA to do anything. Roche showed many of the initial kits had false positive and/or false negative rates over 33%. In response the FDA merely asked companies to file documentation. Manufacturers immediately withdrew 100 different branded test kits because they did not have any appropriate documentation or studies and there products gave erroneous results. No, I have very good reason not to trust the FDA. Edited December 16, 2020 by JimK Link to comment Share on other sites More sharing options...
Barbaraok Posted December 16, 2020 Report Share Posted December 16, 2020 JimK, the reactions in the UK were not true analyphaltic allergic reactions, but rather people who have hyper active immune systems (extremely allergic to certain allergens) react to almost any stimulus (ie, the needle going into the arm) with an over aggressive dump of histamine. Both of those nurses had the initial reactions they get to allergens, but then dissipated as the day went on. A few of the placebo group in the testing also had 'heightened' reactions - not unexpected when doing any study. Everyone's immune system reacts differently. And most people will have a more intense reaction with the second injection since the body has already built up a level of antibodies to what will be injected again. So for some the second injection will be REALLY sore arm at injection site, fever that can spike in the 103-105 range but quickly dissipates, especially if they drink plenty of fluids, muscle aches, headaches, but all will resolve after 8-12 hours. For very allergic reactors, getting the vaccination in a hospital provides the opportunity to get IV Benadryl before getting the injection to calm the immune system. For people at home, make sure you drink lots of water that day, have your favorite OTC fever reducer/pain med handy and if you are sensitive to some things, have your antihistamine on hand. And yes, for those who are very allergic to things, getting the vaccine (under physician's direction) is important because one of the things that has been seen is that the COVID19 virus can initiate a cytokine storm with histamine dumping and causing fluid build up, swelling of throat, etc., leading to death. Barb & Dave O'Keeffe 2002 Alpine 36 MDDS (Figment II), 2018 Ford C-Max HYBRID Blog: http://www.barbanddave.net SPK# 90761 FMCA #F337834 Link to comment Share on other sites More sharing options...
Barbaraok Posted December 16, 2020 Report Share Posted December 16, 2020 (edited) 10 hours ago, JimK said: Did you read the claims for caimon oil? The claims included TREATMENT for a host of DISEASES including: acne, age spots, burns, scalds, dandruff, eczema, joint pain, muscle pain, MRSA infections and nail fungus. Those are medical claims that need approval by the FDA, whether prescription or over the counter. Again, the FDA is worthless in carrying out a majority of its responsibilities. Visit a nutrition store, read the "health" mags, look at the claims on supplements. You will often see: not approved by the FDA for the diagnosis or treatment of disease. But they still make the claims. Since the FDA does nothing the situation has gotten way out of hand and blatant. In addition, you are absolutely wrong. The FDA does indeed regulate the safety of cosmetics. Yes, a lot of them get away with claiming these things because the budget for the FDA doesn't stretch enough to look at claims of 'treatment' of these products. Usually it is when they start widespread advertisements that the FDA steps in. Notice how the 'benefits' of copper fibers in clothing has changed - - because copper bands don't cure or help arthritis, etc. No one disagrees that it would be ideal if the FDA was able to do premarketing tests of all of these 'treatments'. But that isn't the FDAs fault, that is the fault of Congress and of citizens in this country. We don't want to pay taxes, and we keep voting for people who then do whatever their huge money donors want. Edited December 16, 2020 by Barbaraok Barb & Dave O'Keeffe 2002 Alpine 36 MDDS (Figment II), 2018 Ford C-Max HYBRID Blog: http://www.barbanddave.net SPK# 90761 FMCA #F337834 Link to comment Share on other sites More sharing options...
LindaH Posted December 16, 2020 Report Share Posted December 16, 2020 22 hours ago, GlennWest said: Only time I wear one is if store demands it. I hate them. Fogs my glasses up. We were told to clean our glasses with Barbasol to keep glasses from fogging up...it works or at least lessens the fogging (other shaving creams might work, too). Another thing I've found that works to keep my glasses from fogging up is wearing the blue disposable masks because I can get the metal piece at the nose clamped down tighter than our fabric face masks, even the ones with the metal nose strips. For me, I also find the disposable masks to be more comfortable, even when I double up on them. LindaH 2014 Winnebago Aspect 27K 2011 Kia Soul Link to comment Share on other sites More sharing options...
Randyretired Posted December 16, 2020 Report Share Posted December 16, 2020 These vaccines have emergency use clearances for a reason. While the trials included a lot of people there could still be problems for certain people. While it would appear that these vaccines are safe and effective for most, especially healthy people without problems, there are still some unknowns. The Federal Government is tracking every vaccine in case of problems. Those of us with serious concerns might not want to be at the front of the line. As the vaccines are administered to millions instead of thousands problems will have a chance to show. Most of us will have to wait anyhow. Long term problems if any are also still unknown but for me like many I fear Covid more than the vaccine. Sadly my DW and I have a more difficult choice for her. Randy 2001 Volvo VNL 42 Cummins ISX Autoshift Link to comment Share on other sites More sharing options...
Kirk W Posted December 16, 2020 Report Share Posted December 16, 2020 55 minutes ago, Randyretired said: Most of us will have to wait anyhow. Long term problems if any are also still unknown but for me like many I fear Covid more than the vaccine. That pretty well sums things up for us as well. The emergency approval means that it was believed that the risk of moving quickly is less for the total population than the risk caused by taking another 6 months or more to do further testing, as is usually done. The ultimate test has already begun. Good travelin !...............KirkFull-time 11+ years...... Now seasonal travelers.Kirk & Pam's Great RV Adventure Link to comment Share on other sites More sharing options...
Big Rick Posted December 16, 2020 Report Share Posted December 16, 2020 Are people receiving the vaccine tested before hand to see if the have the antibodies already? Seems like they should but with the hurry up and get it done, not likely! Link to comment Share on other sites More sharing options...
Barbaraok Posted December 16, 2020 Report Share Posted December 16, 2020 25 minutes ago, Big Rick said: Are people receiving the vaccine tested before hand to see if the have the antibodies already? Seems like they should but with the hurry up and get it done, not likely! Since we have no idea how long antibodies from natural infection stay in the body, the recommendation is to get the vaccine. There have been cases of re-infection of people, usually worse for them the second time around, so waiting isn't advised for high risk individuals. And we don't know how long the antibodies from the vaccine will last, whether it will become yearly boosters, or hopefully, boosters every few years. When your line is announced, get the vaccine. Barb & Dave O'Keeffe 2002 Alpine 36 MDDS (Figment II), 2018 Ford C-Max HYBRID Blog: http://www.barbanddave.net SPK# 90761 FMCA #F337834 Link to comment Share on other sites More sharing options...
JimK Posted December 16, 2020 Report Share Posted December 16, 2020 The FDA advisory panel was selected from individuals who are strong advocates for vaccines and who work in the field. They were expected to vote positively. Even so there was one abstention and 4 negative votes out of 22 members. Considering the negative impact of Covid and the strong desire for a vaccine, I think that was marginal support. Link to comment Share on other sites More sharing options...
JimK Posted December 16, 2020 Report Share Posted December 16, 2020 3 hours ago, Barbaraok said: Yes, a lot of them get away with claiming these things because the budget for the FDA doesn't stretch enough to look at claims of 'treatment' of these products. ..... That is a poor excuse. The FDA has 15000 employees, huge numbers of contract employees and a multi billion dollar budget. They have virtually unlimited power in demanding documentation of claims, proof of safety and efficacy and the ability to impose substantial fines and send company execs to jail. Instead they rarely, rarely act. Five people working out of a garage could do better than the FDA for regulation of supplements and OTC drugs. Link to comment Share on other sites More sharing options...
Barbaraok Posted December 16, 2020 Report Share Posted December 16, 2020 JimK, you have an unrealistic viewpoint of what FDA can do with the limited employees they have. Of course review panels will have mostly experts in the field. Why are you surprised? To get a group of scientists to agree on EVERYTHING is never going to happen. It is all about looking at data and coming to conscientious as the most beneficial way forward. ALL pharmaceuticals have side effects, all surgeries carry risks, etc. we will never have the perfect and how many ppl will die waiting for the perfect? Barb & Dave O'Keeffe 2002 Alpine 36 MDDS (Figment II), 2018 Ford C-Max HYBRID Blog: http://www.barbanddave.net SPK# 90761 FMCA #F337834 Link to comment Share on other sites More sharing options...
Randyretired Posted December 16, 2020 Report Share Posted December 16, 2020 7 minutes ago, Barbaraok said: JimK, you have an unrealistic viewpoint of what FDA can do with the limited employees they have. Of course review panels will have mostly experts in the field. Why are you surprised? To get a group of scientists to agree on EVERYTHING is never going to happen. It is all about looking at data and coming to conscientious as the most beneficial way forward. ALL pharmaceuticals have side effects, all surgeries carry risks, etc. we will never have the perfect and how many ppl will die waiting for the perfect? I also have to wonder about the FDA. For weeks people were saying the FDA would approve these vaccines and other countries did but the FDA was slow to react. You would think with people dying they would have told their scientists to stop everything and study this data. Work a little overtime if necessary. Finally the committee approved the vaccine but upper management needed days before they reacted. Now we are going through the same with the Maderna vaccine. I guess it is typical government operation. Randy 2001 Volvo VNL 42 Cummins ISX Autoshift Link to comment Share on other sites More sharing options...
JimK Posted December 16, 2020 Report Share Posted December 16, 2020 18 minutes ago, Randyretired said: I also have to wonder about the FDA. For weeks people were saying the FDA would approve these vaccines and other countries did but the FDA was slow to react. ...... The Brits jumped ahead but the FDA was not at all "slow to react". Several panel members wanted additional studies that would have taken several months. Emergency authorization or not, if any serious issues emerge, faith in vaccines will be shattered. There are already way too many antiVAXers. There have also been a lot of assumptions involved. The big one is the length of time immunity might last. That would make sense, except the Pfizer and Moderna vaccines are based on new mRNA technology and are unlike other vaccines in use. If these vaccines fail to protect for many months or years, the cost will be enormous. They are expensive to make and administer but worse the public is not likely to accept the need for additional vaccinations. Link to comment Share on other sites More sharing options...
Kirk W Posted December 16, 2020 Report Share Posted December 16, 2020 (edited) Quote Tomorrow, the agency will review data from trials of another vaccine from Moderna, and emergency approval could follow within hours or days. Both drugs are mRNA vaccines, so named because they inject pieces of a virus’s genetic code (its messenger RNA) into the body. The injection “spurs the production of viral proteins that mimic the coronavirus, training the immune system to recognize its presence,” Amy McKeever writes for Nat Geo. Drugs that rely on mRNA technology have until now been approved only in veterinary medicine, so seeing two candidates prove safe and effective in humans is a landmark achievement. Edited December 16, 2020 by Kirk W Good travelin !...............KirkFull-time 11+ years...... Now seasonal travelers.Kirk & Pam's Great RV Adventure Link to comment Share on other sites More sharing options...
Zulu Posted December 16, 2020 Report Share Posted December 16, 2020 51 minutes ago, Randyretired said: I also have to wonder about the FDA. For weeks people were saying the FDA would approve these vaccines and other countries did but the FDA was slow to react. You would think with people dying they would have told their scientists to stop everything and study this data. Work a little overtime if necessary. Seriously? SKP #79313 / Full-Timing / 2001 National RV Sea View / 2008 Jeep Wrangler Rubiconwww.rvSeniorMoments.comDISH TV for RVs Link to comment Share on other sites More sharing options...
2gypsies Posted December 16, 2020 Report Share Posted December 16, 2020 (edited) 1 hour ago, Randyretired said: I also have to wonder about the FDA. For weeks people were saying the FDA would approve these vaccines and other countries did but the FDA was slow to react. You would think with people dying they would have told their scientists to stop everything and study this data. Work a little overtime if necessary. Finally the committee approved the vaccine but upper management needed days before they reacted. Now we are going through the same with the Maderna vaccine. I guess it is typical government operation. You obviously don't know what's involved with approving drugs. They got this out in unbelievable time.... usually takes years. I'm sure they put in many extra hours!!! I worked with FDA data at a pharmaceutical company. You don't have a clue so don't post misinformation! Here's an example of typical timelines. There's lots more information out there if you choose to know the particulars. https://www.hackensackmeridianhealth.org/HealthU/2020/12/09/behind-the-covid-19-vaccine-approval-process/ Actually, this process did start years ago because of new techniques. https://www.tampabay.com/news/health/2020/12/07/how-did-we-get-a-coronavirus-vaccine-so-fast-years-of-research/ Edited December 16, 2020 by 2gypsies Full-timed for 16 YearsTraveled 8 yr in a 2004 Newmar Dutch Star 40' Motorhome and 8 yr in a 33' Travel Supreme 5th Wheel Link to comment Share on other sites More sharing options...
Big Rick Posted December 16, 2020 Report Share Posted December 16, 2020 Well four pages of everyone trying to show how smart they are and nothing actually accomplished Link to comment Share on other sites More sharing options...
Barbaraok Posted December 17, 2020 Report Share Posted December 17, 2020 2 hours ago, Big Rick said: Well four pages of everyone trying to show how smart they are and nothing actually accomplished Lots of information shared. What else do you expect on a forum? Barb & Dave O'Keeffe 2002 Alpine 36 MDDS (Figment II), 2018 Ford C-Max HYBRID Blog: http://www.barbanddave.net SPK# 90761 FMCA #F337834 Link to comment Share on other sites More sharing options...
Randyretired Posted December 17, 2020 Report Share Posted December 17, 2020 The drug companies certainly were spectacular. For weeks ahead of the approval the press even stated that approval is virtually approved and gave percentages of how well the vaccines were working. Obviously the drug companies did a fabulous job of assembling the data. Enough so that the UK approved it a week before the US. While a week wouldn't seem like much over a million more people contracted covid during that time and hundreds died. Did the UK know something the FDA didn't? Since each came to the same conclusion are we saying the UK didn't do due diligence? After the committee voted for approval there was another delay until management signed off. These timeframes are short but it is hard for many to understand a week more to come to the same conclusion. Randy 2001 Volvo VNL 42 Cummins ISX Autoshift Link to comment Share on other sites More sharing options...
JimK Posted December 17, 2020 Report Share Posted December 17, 2020 If the conclusions were so clear and the need is so high, why do you suppose 5 experts on the panel would not approve the Pfizer vaccine even for emergency use? Link to comment Share on other sites More sharing options...
Recommended Posts