Approval Letter(S) - Fda Home Page - Food And Drug Administration: Fill & Download for Free

Hello Lily! Thank you for asking me to answer your question. It’s long but I wanted to make sure I covered many of the bases that you will cross on your path to creating a product for use in the United States especially or for import into the U.S.Since you aren’t specific as to the product or idea (understandably), I’ll just give you some of the basics of what I know or rather my interpretation having written extensively about the FDA and Cosmetics. I’ve also spent most of my adult life in Sales and Marketing so this is somewhat second nature to me.Feel free to comment or message if you have any questions but a caveat . . . . I don’t work for the FDA nor do I have connections with anyone who works there. I read and digest a lot and I make phone calls when I’m not sure about something I’ve read.Here we go…….Whether you are speaking of color products or skin care, the markets are over-saturated. However, you can absolutely have a viable company and a number one selling product if you have ………An idea for a product that is unique.A new idea that's makes an old product better.Conducted extensive market studies to determine the interest in your idea/product.Determined the demographic likely to buy your product and if large enough to sustain your business.Done a cost analysis of your product to determine if your demographic can afford your product.Determined if your product is limited to a specific geographic location (this could have an impact on your ability to sell nation or world wide).The capital to stay in business until you turn a profit. In some cases this can be a year or two or longer depending on your product and many other factors.A solid business plan and marketing strategy.Conducted proper research and development (R&D) in accordance with your nation’s guidelines, laws and regulations or those in the United States.Follow to the letter, all government agency laws and regulations and guidelines. If you are in the U.S. or plan to import into the U.S. the above applies under our regulating agency, the U.S. Food and Drug Administration (FDA) and the laws and regulations under the FD&C Act to name a few. For complete information, go to the FDA website and click the tab “Cosmetics”U S Food and Drug Administration Home PageSome are confused by the terminology that the FDA regulates “Cosmetics”. Many assume that to mean color cosmetics such as blush, lipstick, eye shadow, foundation, etc. It does but it also means just about everything you put on your skin/body from head to toe.From the FDA . . . . . . .The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. [1]The FDA becomes an “approving authority” when your cosmetic product contains a color or is classified as a drug. In their example found in citation [1] above, the FDA states a shampoo is a cosmetic but a dandruff shampoo is a drug. A moisturizer or foundation is a cosmetic but if it claims to have an additive to protect your skin from the sun it becomes classified as a drug.While you can be successful, I go back to the old adage “Necessity is the Mother of Invention.” If you can fill a void in the market or create a product that convinces your demographic that yours will change their life or will have a positive effect if they buy it, you've got a winner of an idea.Go for it!CarolFootnotes[1] Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

CANCER IS SERIOUS BUSINESS (Read it, it may save your life)A quote worth sharing“The system is rigged. They want us to believe that it'll protect us, but that's a lie. We protect us. We do. Nobody else. Not the companies, not the scientists, not the government”. 'Us'. - Rob Bilott (Dark Waters)The Man who cured CancerForgotten Genius: “Royal Raymond Rife”The inventor and his invaluable contributions to imaging and medical microscopyScience has known for quite some time that all things vibrate at their own personal frequency. Certain emotions sustained over time can change our vibrational frequencies and manifest in illness. Recently I read an article that explained how current research is using resonant frequency to destroy cancer cells. As exciting as that prospect is, it’s not a new approach. Royal Raymond Rife made an invaluable contribution to medical microscopes.As a scientist, inventor, and engineer, particularly in imaging and medical microscopy, Royal Raymond Rife was a genius. He was to medical optics what Nikola Tesla was to physics. In 1913, industrial tycoon Henry Timken of the Timken Roller Bearing Company in Canton, Ohio, sought Rife’s help to solve a manufacturing problem. The solution was a scanning machine that could evaluate the quality of the steel used in the company’s roller bearings before going into production. The scanner improved the quality of the company’s products and streamlined production to such a degree that Timken was overjoyed. When he learned that Rife’s passion was medical imaging, Timken gave him his full financial support and set him up at the family’s estate in San Diego to create his personal lab. No expense was too great and nothing was held back.Rife’s previous work had led him to believe that microorganisms (bacteria, viruses, and parasites) were at the root of all disease. To prove his theory, he had to see these pathogens in their live state during his experiments, some of which were so small, particularly viruses, that no imaging equipment existed that could come close to viewing them. That wasn’t a stumbling block to Rife. As a mechanical engineer and microscopy expert, he built a microscope that could magnify 60,000 times, and the superior magnification was equaled by its resolution. The microorganisms Rife was viewing were so infinitesimally small that the atoms in the chemical stain normally used to expose microorganisms would have obscured them. Instead Rife’s microscope used monochromatic light that caused the organism to fluoresce. Rife could identify the virus he was observing by the color it refracted.Years later in 1944, both the “Journal of the Franklin Institute for Scientific and Mechanical Arts and The Smithsonian” featured the Rife Universal Microscope alongside the newly created electron microscope in articles on emerging technology in optics. In The Smithsonian article entitled “The New Microscopes,” three micrographs from the Rife Universal Microscope were printed. The resolution of those images was unmatched by any existing technology, including the electron microscope. In fact they’re still unmatched even by today’s technology. What’s more, those images were taken ten years prior by Rife in 1934. Rife discovered that a simple electromagnetic wave wasn’t enough to destroy a microorganism. Instead he found a radio frequency wave was readily accepted by the body if it was emitted by a gas within a glass tube. The other astounding feature of the Rife Universal Microscope was that viruses could be viewed in their live state, like a movie, whereas the electron microscope could only view viruses in still images, or like photos. When studying any organism, observing how it moves and behaves in real time provides much more valuable information than viewing it as a static image. Over the course of 20 years, Rife would build five of his microscopes, some requested by the most prestigious research scientists in the world. The Rife Universal Microscope created a paradigm shift in pathology and microbiology research because much of what his device could do is still considered impossible today. But the biggest change was yet to come. Knowing everything vibrated at its own frequency, Rife believed that if he could discover the vibrational frequencies at which disease-causing microorganisms vibrated, then he could bombard them with that frequency until they shook so hard they exploded, the same way an opera singer matches the frequency of a wine glass with her voice and shatters it. Rife discovered that a simple electromagnetic wave wasn’t enough to destroy a microorganism. Instead he found a radio frequency wavThe other astounding feature of the Rife Universal Microscope was that viruses could be viewed in their live state, like a movie, whereas the electron microscope could only view viruses in still images, or like photos. When studying any organism, observing how it moves and behaves in real time provides much more valuable information than viewing it as a static image.Over the course of 20 years, Rife would build five of his microscopes, some requested by the most prestigious research scientists in the world. The Rife Universal Microscope created a paradigm shift in pathology and microbiology research because much of what his device could do is still considered impossible today. But the biggest change was yet to come.Knowing everything vibrated at its own frequency, Rife believed that if he could discover the vibrational frequencies at which disease-causing microorganisms vibrated, then he could bombard them with that frequency until they shook so hard they exploded, the same way an opera singer matches the frequency of a wine glass with her voice and shatters it.Rife discovered that a simple electromagnetic wave wasn’t enough to destroy a microorganism. Instead he found a radio frequency wave was readily accepted by the body if it was emitted by a gas within a glass tube. This allowed the frequency wave to penetrate deeply into the body with scalpel-like precision. Because the wave was precisely tuned to the frequency of the microorganism, only the pathogen was affected, leaving the surrounding tissue unharmed.Rife considered a disease cured when he could destroy a microorganism ten consecutive times using what he called its Mortal Oscillatory Rate (MOR). His surviving records show he found the MOR for 24 microorganisms including anthrax, cholera, tetanus, B. coli, influenza, spinal meningitis, tuberculosis, pneumonia, syphilis, gonorrhea, leprosy, streptococcus, conjunctivitis, bubonic plague, staphylococcus, diphtheria, and typhoid.It’s exciting and enraging to think that cancer, along with many other diseases, was cured 83 years ago, and yet half a million people die from malignancies every year.By now Rife’s accomplishments were attracting a lot of attention from the press and he was working with the most respected medical experts of the day. These included Dr. E. C. Rosenow, bacteriologist and head of the pathology department at the Mayo Clinic, Dr. Arthur Kendall, bacteriologist at Northwestern University, Dr. Milbank Johnson of the University of Southern California (USC) and head of the Medical Society of California, Lee De Forrest, technology scientist, and William D. Coolidge, physicist.Unfortunately Rife was also attracting a lot of negative press, mainly from the FDA, American Medical Association, medical establishment and Harvard University. To prove his detractors wrong, he along with Dr. Rosenow invited several of Rife’s most prestigious but severest critics to a demonstration where he destroyed the poliomyelitis virus with its MOR (Mortal Oscillatory Rate) in 1932, twenty years before the vaccine was invented and thirty years before it became available to the public.Hidden beneath his critics’ astonishment at what they’d seen was panic. They knew Rife’s microscope and beam-ray technology would mean the loss of billions of dollars to hospitals, pharmaceutical companies, and research institutes, not to mention the overnight elimination of entire fields of medical science and research, as well as the discrediting of thousands of careers of the most highly respected university and medical center physicians, scientists and administrators. Just days after the demonstration, Dr. Rosenow was fired from his position at the Mayo Clinic, and the fix was in to bury Rife’s research.Uneasy about Dr. Rosenow’s fate and what might be brewing for him behind the scenes, Rife pressed on. He knew a microorganism was at the root of cancer and was determined to find it. That same year, he discovered a virus in a breast tumor that he called the BX virus. Even more, he found the BX virus to be pleomorphic, meaning that it changed form based on its terrain. He discovered its MOR and was able to destroy it.Never having used his beam ray on a living creature, Rife introduced the BX virus into rats. Sure enough, they developed huge tumors. Using his beam ray to expose the tumors to their MOR, Rife was able to completely heal the rats. Seeing these incredible results, Dr. Johnson from USC insisted that it was time to try the beam ray on human patients. Rife was apprehensive, but insisted that if they were to have human trials, a research committee comprised of physicians at the top of the most prestigious medical associations had to be part of the proceedings. Dr. Johnson agreed and pulled a committee together that even included Dr. Alvin Ford, President of the American Association of Pathologists, a member Rife specifically requested.The trials included 16 terminally ill patients with various cancers and were conducted at the Ella Scripps mansion and estate in La Jolla, CA in 1934. In just 70 days, the committee declared the first 14 patients cured of their cancer. The remaining two were declared cured three weeks later. Incredibly, the patients only required two 3-minute sessions per week to achieve total recovery. Rife found that more-frequent sessions didn’t allow the lymphatic system enough time to take up the released toxins from the destroyed virus and remove them from the body.Later that year, a black tie banquet was held to honor Rife and “Celebrate the End of All Disease.” Less than 15 years later, however, none of the people at that dinner would even admit to knowing Rife, who would be left in poverty with his career ruined. His five microscopes would be confiscated along with the majority of his records and the two known beam-ray machines in existence. Today scientists are still struggling to recreate Rife’s technology from the remnants of what wasn’t destroyed of his writings.It’s exciting and enraging to think that cancer, along with many other diseases, was cured 83 years ago, and yet half a million people die from malignancies every year. As an institution mired in politics and money, the medical establishment seems to be the worst at killing its prophets and saints. Hopefully this new generation of courageous scientists will be able to put together the pieces from an unsung genius and recreate the “end of all disease” in his memory.Hyperthermia (up to 113°F) kills cancer cell usually with minimal injury to normal tissue research should be done to channel and target it for curing cancer without damaging our brain and other organs.Watch it before it gets removed“Cancer cure coverup” Dr. S. R. Burzynski another genius who cured cancer.A pioneering medical doctor and PhD biochemist who won the largest and possibly the most convoluted legal battle against the Food and Drug Administration in American history. Burzynski's battles were centered on his belief in Antineoplastons, a gene-targeting cancer therapy he discovered in the 1970s. The ultimate approval of Antineoplastons would mark the first time in history a single scientist, not a pharmaceutical company, would hold the exclusive patent and distribution rights on a paradigm-shifting, life-saving medical breakthrough. Burzynski's first-person testimonials of cancer patients who chose his treatment instead of surgery, chemotherapy or radiation with full disclosure of original medical records to support their diagnosis and recovery.There is almost nothing about this film that isn't controversial. Even the Wikipedia entry, which is pretty tough on the doctor and his treatment, is challenged by the flims website, which claims "the Wikipedia editors refuse to allow anything that show these medicines in a positive light to be allowed to be included in the Wiki post."Watch the documentary by Eric Merola.Must watch might save someone's lifeDid you know?Ignaz Philipp Semmelweis, a Hungarian physician and scientist, now known as an early pioneer of antiseptic procedures. Described as the "saviour of mothers".Semmelweis discovered that the incidence of puerperal fever (also known as "childbed fever") could be drastically cut by the use of hand disinfection in obstetrical clinics. Puerperal fever was common in mid-19th-century hospitals and often fatal. Semmelweis proposed the practice of washing with chlorinated lime solution in 1847 while working in Vienna General Hospital First Obstetrical Clinic, where doctors' wards had three times the mortality of midwives wards.He published a book of his findings in Etiology, Concept and Prophylaxis of Childbed Fever.Despite various publications of results where hand washing reduced mortality to below 1%, Semmelweis's observations conflicted with the established scientific and medical opinions of the time and his ideas were rejected by the medical community. He could offer no acceptable scientific explanation for his findings, and some doctors were offended at the suggestion that they should wash their hands and mocked him for it. In 1865, the increasingly outspoken Semmelweis supposedly suffered a nervous breakdown and was committed to an asylum by his colleagues. He died 14 days later after being beaten by the guards, from a gangrenous wound on his right hand which might have been caused by the beating. Semmelweis's practice earned widespread acceptance only years after his death, when Louis Pasteur confirmed the germ theory, and Joseph Lister, acting on the French microbiologist's research, practised and operated using hygienic methods, with great success.Must ReadFor the past 27 years, Life Extension has identified life-saving medications that languished too long in the FDA’s archaic approval process.When effective new drugs are delayed, the inevitable consequence is needless human suffering and death. An equally insidious problem is the chilling effect bureaucratic roadblocks have on the development of better drugs that might actually cure the disease.Just imagine the difficulty of raising the tens of millions of dollars needed to get a new cancer drug into the approval pipeline when prospective investors see the FDA deny a drug with documented efficacy, as was done recently with Provenge. (Refer to page 7 for the complete story of the FDA’s denial of Provenge.)Another problem with the FDA’s unpredictable approval pattern is the outrageous cost of the cancer drugs that actually make it to market. Classes of cancer drugs (like anti-angiogenesis agents) that Life Extension long ago advocated are finally approved. The problem is that the out-of-pocket cost of these new drugs can exceed $12,000 per month. The media has reported on heart-wrenching stories of cancer patients who choose to die rather than send their families into bankruptcy from paying these costs.It’s easy to point fingers at drug companies for charging such extortionist prices, but the harsh reality is that getting these medications approved by the FDA is so costly and risky that the high prices can arguably be justified by the hideously inefficient drug approval process that now exists.In this article, we review a few of many drugs that have been shown to be effective against cancer, but are not yet approved by the FDA. While there are dozens of anti-cancer drugs in various stages of the approval process, the sad truth is that thousands of compounds with anti-cancer activity will never be submitted for FDA approval due to lack of patentability, lack of investor funding, or just plain unwillingness to deal with today’s cancer bureaucracy.It has become brutally apparent that the system of drug approval needs a radical overhaul. We have some specific proposals at the end of this eye-opening article.Each day, about 1,500 Americans perish from cancer. Each day, over 3,000 Americans are diagnosed with this dreaded disease.1 While the general population is relatively ignorant about medicine, virtually everyone knows that a cancer diagnosis means exposure to therapies that produce miserable—if not lethal—side effects. The public is also aware that in too many cases, government-approved therapies fail to cure the disease.*Now im gonna tell you something which you might find as a complete shocker*A conversation with the lawyer Rob Bilott is like a slap across the face. It doesn’t feel good. But it does get your attention.According to Bilott, we face a “unique health threat” from a class of industrial chemicals that most Americans have never heard of. These chemicals are widely used in everyday products such as non-stick cookware and stain-resistant fabrics, even though science show they are linked to a range of deadly diseases, reproductive problems and other ailments. Powerful corporations are fighting to protect the use of these profitable chemical compounds, Bilott says, and US regulators are doing next to nothing to stop them. It’s worth listening to what Bilott has to say. He has spent the last two decades advocating for people in West Virginia and Ohio whose water was contaminated with one of these toxins, a chemical called perfluorooctanoic acid, or PFOA.Do watch these movies if you haven't watched it yet. Based on this agenda.*Now lets get into some details*3MPFAS DANGER3M has long known it was contaminating the US food supplyMultinational manufacturer 3M, which developed two types of industrial chemical now found in the blood of virtually all Americans, has known since 2001 that those chemicals were entering the food supply, according to a newly surfaced study.That year, the company sponsored a study of several types of food from around the US. The study surfaced this week, when the Intercept’s Sharon Lerner reported that the document was on file with the US Environmental Protection Agency.3M made Scotchgard and other non-stick, waterproof, or stain-resistant products using PFOA and PFOS, two chemicals in a class known as PFAS. Production of Scot ended after 2000. In 2001, 3M funded the study to test food samples from six US cities. High levels of the compounds were found in ground beef, milk, green beans and apples. The contaminated food came from Alabama, Tennessee, Florida, and Georgia.In a statement to Quartz, 3M said it published the report in 2001 and “shared this report with the EPA within seven days,” adding, “This report is one of thousands of documents we have placed in the public domain related to the study of PFAS chemistries. We will continue to engage with members of our communities, elected officials and regulators to share information about these chemistries,” 3M wrote.What 3M knew about PFASAs Lerner has reported, 3M knew as early as the 1970s that PFAS was accumulating in human blood, and conducted experiments on rats and monkeys that led the company to believe the compounds “should be regarded as toxic.”PFAS do not degrade in the environment. Decades of use has created a widespread and ongoing Contamination crisis. At this point, most people in the US have been exposed to chemicals in the PFAS family, of which there are as many as 5,000, and water supplies serving tens of millions are likely contaminated as well. The revelation about PFAS entering the food supply, however, is a relatively new addition to the roster of ways people have been exposed.PFAS chemicals have been linked to a range of health risks including cancer, thyroid disease, elevated cholesterol, immune-system issues, and developmental problems in fetuses.Both 3M and DuPont have ceased production of PFOA and PFAS in the US, but DuPont continues to manufacture it in China. In Brazil, contamination is widespread due to a popular pesticide that degrades into PFAS. In Jordan0, researchers found PFAS in women’s breast milk at levels more than double the advised US health level. American dairy farmers have found PFAS in their milk. Other chemicals in the PFAS family, including GenX, continue to be manufactured in places like North Carolina.Decades of widespread use of PFAS for everything from waterproofing clothes to firefighting foam has made the exposure global: Health issues arising from PFAS are estimated to cost Europe 50 billion euros per year. A UN committee responsible for toxic chemical policy agreed to ban the compounds this year (the US is not party to the pact).PFAS back in the newsWord of the 19-year-old 3M study comes a week after nonprofit Environmental Working Group published a photo of a poster containing unreleased US Food and Drug Administration findings about PFAS in food. The agency detected PFAS in chocolate cake, meat, seafood, sweet potatoes, and pineapple. It was the first known test of food for PFAS by the FDA.After EWG’s poster release, the FDA published its findings along with a press release stating that the “FDA does not have any indication that these substances are a human health concern” at the levels detected, adding that the “science surrounding the potential health effects of PFAS is developing” and “current evidence suggests that the bioaccumulation of certain PFAS may cause serious health conditions.”“However, with the decrease in production and use of certain PFAS, levels in humans in the US have been declining,” the FDA added.As Lerner reports, Rob Bilott—whose 1999 lawsuit against DuPont on behalf of residents near its Teflon plant in West Virginia put PFAS contamination on the map wrote a June 11 letter to the FDA asking whether it knew about 3M’s food study before now and if how long officials knew there were high levels of the compounds in food.The FDA said in a statement that it has received Bilott’s letter “and is reviewing it at this time.”Why are highly fluorinated chemicals harmful?Highly fluorinated chemicals contain carbon-fluorine (C-F) bonds, which are some of the strongest bonds in nature. That makes them both incredibly resistant to breakdown and very useful. For instance, they can make products grease or stain-resistant, nonstick, or waterproof. However, this comes at a cost.The highly fluorinated chemicals that have been well-studied have been associated with:testicular and kidney cancerliver malfunctionhormonal changesthyroid disruptionhigh cholesterolobesityulcerative colitislower birth weight and sizeOther highly fluorinated chemicals are suspected of similarly causing health problems, but have not been well tested.Because they are resistant to breakdown, these chemicals can persist in our bodies for years. In the environment, they can last for millions of years. This means that the highly fluorinated chemicals released during our lifetimes will build up in the environment, and many future generations will be exposed to them, at even higher levels than we are today.Scientists from all over the world signed the Madrid Statement to share their concerns about highly fluorinated chemicals and are asking for a limit to the production and use of these chemicals.On May 1, 2015, the Madrid Statement was published in Environmental Health Perspectives, a high-impact scientific journal.How are we exposed?Highly fluorinated chemicals are used in consumer products such as cookware, clothing, outdoor apparel, carpeting, and food packaging to provide nonstick, oil- and water resistant properties. They are also used in some kinds of cosmetics.We are exposed to them by direct contact with these products, but also through the air we breathe, the water we drink, and the food we eat.They have been detected at high levels in humans and wildlife all over the globe.What can you do?Ask yourself, “Do I really need products that are stain-resistant, nonstick, or waterproof?” Knowing the consequences, you might choose to give up some conveniences or product performance.Steps you can take:Avoid products that are oil repellant or stain resistant.Only purchase waterproof gear when you really need it.Avoid cosmetics with PTFE or any word containing “perfluor” or “polyfluor” on their ingredients list.Replace your Teflon nonstick cookware with cast iron, glass, or ceramic.Avoid microwave popcorn and greasy foods wrapped in paper.Tell retailers and manufacturers you want products without fluorinated chemicals.Support companies committed to phasing out highly fluorinated chemicals, such as the apparel brands that have joined Greenpeace’s detox campaign, and the fast food chains that removed them from food packaging as a result of EWG's action.If you are concerned about PFAS in your drinking water, consider installing an in-home filter on your tap. EWG summarized what is known about the efficacy of the different filter options.All products from these apparel brands are free of highly fluorinated chemicals after these dates.Look Carefully at the imagesHarsh truth is that medical facilities prioritise business rather than treatment and patient are customer for few doctor's.*SOURCES*Forgotten Genius: Royal Raymond Rife - Be Hive Of HealingHyperthermia in Cancer Treatment.Cancer Is 'Serious Business.' Is the 'Documentary'?'My Cancer Free Life'? Not So FastBurzynski: The Cancer Cure Cover-UpIgnaz Semmelweis - WikipediaThe Lawyer Who Became DuPont’s Worst Nightmare3M knew it was contaminating the food supply back in 2001Highly Fluorinated ChemicalsImage source- Google“Must Read” External LinkLife-Saving Cancer Drugs Not Approved by the FDA

Interesting that you should ask. Just a week or so ago, I ran across a list of Trump’s accomplishments in just 24 months in office. Just to compare, I also looked up Joe Biden’s record of accomplishments made in 44 years of service.I’ll list Joe’s first…1960: “[O]ne of the best pass receivers I had in 16 years as a coach.” — E. John Walsh, football coach at Archmere Academy.1965: Bachelor of Arts degree from the University of Delaware in Newark, with a double major in history and political science and a minor in English.1968: Graduated from Syracuse University College of Law with a law degree.1969: Admitted to the Delaware bar.1970-72: Served on New Castle County Council.1972-77: Single parent to two sons, commuting on Amtrak 75 minutes each way between his home in Wilmington, Delaware and Washington, D.C.Joe Biden: Senate accomplishments1973-2009: U.S. Senator from Delaware, initially focussing on consumer protection, environmental issues, government accountability, and arms control. In his 6 terms as a senator, Joe Biden sponsored or co-sponsored 348 pieces of legislation that became law.1981-97: Chairman or Ranking Member of the Senate Judiciary Committee for 17 years.1986: Introduced his Global Climate Protection Act, one of the first bills aimed at addressing climate change.1990s: Authored every major piece of crime legislation this decade, including the Violent Crime Control and Law Enforcement Act of 1994.1992-1995: Strongly guided Balkans policy in the mid-1990s during the Bosnian War, producing a successful NATO peacekeeping effort.1994: Spearheaded the Violence Against Women Act, criminalizing violence against women and creating unprecedented resources for survivors of assault, which was followed by a 64% drop in domestic violence from 1993 to 2010.1997-2009: Chairman or Ranking Member of the Senate Foreign Relations Committee for 12 years, leading legislation related to terrorism, weapons of mass destruction, post-Cold War Europe, the Middle East, and Southwest Asia.1997: Led the Senate to approve ratification of the Chemical Weapons Convention.1998: Led the Senate to approve NATO enlargement and passage of bills to streamline foreign affairs agencies and punish religious persecution overseas.1999: Co-sponsored the McCain-Biden Kosovo Resolution, which called on President Clinton to use all necessary force, including ground troops, to confront Milošević over Yugoslav actions in Kosovo.2000: Sponsored the Kids 2000 Act, establishing a public-private partnership to provide computer centers, teachers, Internet access, and technical training to young people, particularly low-income and at-risk youth.Joe Biden: Vice President accomplishments-2017: Vice President of the United States.2009: Implemented and oversaw the $840 billion stimulus package in the American Recovery and Reinvestment Act.2009: Chaired the Middle Class Working Families Task Force.2010: Fought for Congressional approval of the Dodd-Frank Wall Street Reform and Consumer Protection Act, which inserted accountability into the financial sector and fortified the stability of the financial system.2011: Led negotiations between Congress and the White House in resolving federal spending levels for the rest of the year and avoiding a government shutdown. Negotiated with Mitch McConnell to agree on deficit-reducing Budget Control Act of 2011.2012: Headed the Gun Violence Task Force in the aftermath of the Sandy Hook Elementary School shooting.2012: Negotiated a deal with Mitch McConnell that led to the American Taxpayer Relief Act of 2012, averting a fiscal cliff and implementing the largest middle-class tax cut in history.2014: Co-chaired White House Task Force to Protect Students from Sexual Assault.2014: Served as the Obama administration’s emissary to Eastern European governments like Poland, Lithuania, and Ukraine worried over Vladimir Putin’s ambitions in the region.Here’s Trumps list…..Economic Growth4.2 percent growth in the second quarter of 2018.For the first time in more than a decade, growth is projected to exceed 3 percent over the calendar year.Jobs4 million new jobs have been created since the election, and more than 3.5 million since Trump took office.More Americans are employed now than ever before in our history.Jobless claims at lowest level in nearly five decades.The economy has achieved the longest positive job-growth streak on record.Job openings are at an all-time high and outnumber job seekers for the first time on record.Unemployment claims at 50 year lowAfrican-American, Hispanic, and Asian-American unemployment rates have all recently reached record lows.African-American unemployment hit a record low of 5.9 percent in May 2018.Hispanic unemployment at 4.5 percent.Asian-American unemployment at record low of 2 percent.Women’s unemployment recently at lowest rate in nearly 65 years.Female unemployment dropped to 3.6 percent in May 2018, the lowest since October 1953.Youth unemployment recently reached its lowest level in more than 50 years.July 2018’s youth unemployment rate of 9.2 percent was the lowest since July 1966.Veterans’ unemployment recently hit its lowest level in nearly two decades.July 2018’s veterans’ unemployment rate of 3.0 percent matched the lowest rate since May 2001.Unemployment rate for Americans without a high school diploma recently reached a record low.Rate for disabled Americans recently hit a record low.Blue-collar jobs recently grew at the fastest rate in more than three decades.Poll found that 85 percent of blue-collar workers believe their lives are headed “in the right direction.”68 percent reported receiving a pay increase in the past year.Last year, job satisfaction among American workers hit its highest level since 2005.Nearly two-thirds of Americans rate now as a good time to find a quality job.Optimism about the availability of good jobs has grown by 25 percent.Added more than 400,000 manufacturing jobs since the election.Manufacturing employment is growing at its fastest pace in more than two decades.100,000 new jobs supporting the production & transport of oil & natural gas.American IncomeMedian household income rose to $61,372 in 2017, a post-recession high.Wages up in August by their fastest rate since June 2009.Paychecks rose by 3.3 percent between 2016 and 2017, the most in a decade.Council of Economic Advisers found that real wage compensation has grown by 1.4 percent over the past year.Some 3.9 million Americans off food stamps since the election.Median income for Hispanic-Americans rose by 3.7 percent and surpassed $50,000 for the first time ever in history.Home-ownership among Hispanics is at the highest rate in nearly a decade.Poverty rates for African-Americans and Hispanic-Americans have reached their lowest levels ever recorded.American OptimismSmall business optimism has hit historic highs.NFIB’s small business optimism index broke a 35 year-old record in August.SurveyMonkey/CNBC’s small business confidence survey for Q3 of 2018 matched its all-time high.Manufacturers are more confident than ever.95 percent of U.S. manufacturers are optimistic about the future, the highest ever.Consumer confidence is at an 18-year high.12 percent of Americans rate the economy as the most significant problem facing our country, the lowest level on record.Confidence in the economy is near a two-decade high, with 51 percent rating the economy as good or excellent.American BusinessInvestment is flooding back into the United States due to the tax cuts.Over $450 billion dollars has already poured back into the U.S., including more than $300 billion in the first quarter of 2018.Retail sales have surged. Commerce Department figures from August show that retail sales increased 0.5 percent in July 2018, an increase of 6.4 percent from July 2017.ISM’s index of manufacturing scored its highest reading in 14 years.Worker productivity is the highest it has been in more than three years.Steel and aluminum producers are re-opening.Dow Jones Industrial Average, S&P 500, and NASDAQ have all notched record highs.Dow hit record highs 70 times in 2017 alone, the most ever recorded in one year.DeregulationAchieved massive deregulation at a rapid pace, completing 22 deregulatory actions to every one regulatory action during his first year in office.Signed legislation to roll back costly and harmful provisions of Dodd-Frank, providing relief to credit unions, and community and regional banks.Federal agencies achieved more than $8 billion in lifetime net regulatory cost savings.Rolled back Obama’s burdensome Waters of the U.S. rule.Used the Congressional Review Act to repeal regulations more times than in history.Tax CutsBiggest tax cuts and reforms in American history by signing the Tax Cuts and Jobs act into lawProvided more than $5.5 trillion in gross tax cuts, nearly 60 percent of which will go to families.Increased the exemption for the death tax to help save Family Farms & Small Business.Nearly doubled the standard deduction for individuals and families.Enabled vast majority of American families will be able to file their taxes on a single page by claiming the standard deduction.Doubled the child tax credit to help lessen the financial burden of raising a family.Lowered America’s corporate tax rate from the highest in the developed world to allow American businesses to compete and win.Small businesses can now deduct 20 percent of their business income.Cut dozens of special interest tax breaks and closed loopholes for the wealthy.9 in 10 American workers are expected see an increase in their paychecks thanks to the tax cuts, according to the Treasury Department.More than 6 million of American workers have received wage increases, bonuses, and increased benefits thanks to tax cuts.Over 100 utility companies have lowered electric, gas, or water rates thanks to the Tax Cuts and Jobs Act.Ernst & Young found 89 percent of companies planned to increase worker compensation thanks to the Trump tax cuts.Established opportunity zones to spur investment in left behind communities.Worker DevelopmentEstablished a National Council for the American Worker to develop a national strategy for training and retraining America’s workers for high-demand industries.Employers have signed Trump’s “Pledge to America’s Workers,” committing to train or retrain more than 4.2 million workers and students.Signed the first Perkins CTE reauthorization since 2006, authorizing more than $1 billion for states each year to fund vocational and career education programs.Executive order expanding apprenticeship opportunities for students and workers.Domestic InfrastructureProposed infrastructure plan would utilize $200 billion in Federal funds to spur at least $1.5 trillion in infrastructure investment across the country.Executive order expediting environmental reviews and approvals for high priority infrastructure projects.Federal agencies have signed the One Federal Decision Memorandum of Understanding (MOU) streamlining the federal permitting process for infrastructure projects.Rural prosperity task force and signed an executive order to help expand broadband access in rural areas.Health CareSigned an executive order to help minimize the financial burden felt by American households Signed legislation to improve the National Suicide Hotline.Signed the most comprehensive childhood cancer legislation ever into law, which will advance childhood cancer research and improve treatments.Signed Right-to-Try legislation, expanding health care options for terminally ill patients.Enacted changes to the Medicare 340B program, saving seniors an estimated $320 million on drugs in 2018 alone.FDA set a new record for generic drug approvals in 2017, saving consumers nearly $9 billion.Released a blueprint to drive down drug prices for American patients, leading multiple major drug companies to announce they will freeze or reverse price increases.Expanded short-term, limited-duration health plans.Let more employers to form Association Health Plans, enabling more small businesses to join together and affordably provide health insurance to their employees.Cut Obamacare’s burdensome individual mandate penalty.Signed legislation repealing Obamacare’s Independent Payment Advisory Board, also known as the “death panels.”USDA invested more than $1 billion in rural health care in 2017, improving access to health care for 2.5 million people in rural communities across 41 statesProposed Title X rule to help ensure taxpayers do not fund the abortion industry in violation of the law.Reinstated and expanded the Mexico City Policy to keep foreign aid from supporting the global abortion industry.HHS formed a new division over protecting the rights of conscience and religious freedom.Overturned Obama administration’s midnight regulation prohibiting states from defunding certain abortion facilities.Signed executive order to help ensure that religious organizations are not forced to choose between violating their religious beliefs by complying with Obamacare’s contraceptive mandate or shutting their doors.Combating OpioidsChaired meeting the 73rd General Session of the United Nations discussing the worldwide drug problem with international leaders.Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand, introducing new measures to keep dangerous drugs out of our communities.$6 billion in new funding to fight the opioid epidemic.DEA conducted a surge in April 2018 that arrested 28 medical professions and revoked 147 registrations for prescribing too many opioids.Brought the “Prescribed to Death” memorial to President’s Park near the White House, helping raise awareness about the human toll of the opioid crisis.Helped reduce high-dose opioid prescriptions by 16 percent in 2017.Opioid Summit on the administration-wide efforts to combat the opioid crisis.Launched a national public awareness campaign about the dangers of opioid addiction.Created a Commission on Combating Drug Addiction and the Opioid Crisis which recommended a number of pathways to tackle the opioid crisis.Led two National Prescription Drug Take Back Days in 2017 and 2018, collecting a record number of expired and unneeded prescription drugs each time.$485 million targeted grants in FY 2017 to help areas hit hardest by the opioid crisis.Signed INTERDICT Act, strengthening efforts to detect and intercept synthetic opioids before they reach our communities.DOJ secured its first-ever indictments against Chinese fentanyl manufacturers.Joint Criminal Opioid Darknet Enforcement (J-CODE) team, aimed at disrupting online illicit opioid sales.Declared the opioid crisis a Nationwide Public Health Emergency in October 2017.Law and OrderMore U.S. Circuit Court judges confirmed in the first year in office than ever.Confirmed more than two dozen U. S. Circuit Court judges.Followed through on the promise to nominate judges to the Supreme Court who will adhere to the ConstitutionNominated and confirmed Justice Neil Gorsuch and Brett Kavanaugh to the Supreme Court.Signed an executive order directing the Attorney General to develop a strategy to more effectively prosecute people who commit crimes against law enforcement officers.Launched an evaluation of grant programs to make sure they prioritize the protection and safety of law enforcement officers.Established a task force to reduce crime and restore public safety in communities across Signed an executive order to focus more federal resources on dismantling transnational criminal organizations such as drug cartels.Signed an executive order to focus more federal resources on dismantling transnational criminal organizations such as drug cartels.Violent crime decreased in 2017 according to FBI statistics.$137 million in grants through the COPS Hiring Program to preserve jobs, increase community policing capacities, and support crime prevention efforts.Enhanced and updated the Project Safe Neighborhoods to help reduce violent crime.Signed legislation making it easier to target websites that enable sex trafficking and strengthened penalties for people who promote or facilitate prostitution.Created an interagency task force working around the clock to prosecute traffickers, protect victims, and prevent human trafficking.Conducted Operation Cross Country XI to combat human trafficking, rescuing 84 children and arresting 120 human traffickers.Encouraged federal prosecutors to use the death penalty when possible in the fight against the trafficking of deadly drugs.New rule effectively banning bump stock sales in the United States.Border Security and ImmigrationSecured $1.6 billion for border wall construction in the March 2018 omnibus bill.Construction of a 14-mile section of border wall began near San Diego.Worked to protect American communities from the threat posed by the vile MS-13 gang.ICE’s Homeland Security Investigations division arrested 796 MS-13 members and associates in FY 2017, an 83 percent increase from the prior year.Justice worked with partners in Central America to secure criminal charges against more than 4,000 MS-13 members.Border Patrol agents arrested 228 illegal aliens affiliated with MS-13 in FY 2017.Fighting to stop the scourge of illegal drugs at our border.ICE HSI seized more than 980,000 pounds of narcotics in FY 2017, including 2,370 pounds of fentanyl and 6,967 pounds of heroin.ICE HSI dedicated nearly 630,000 investigative hours towards halting the illegal import of fentanyl.ICE HSI made 11,691 narcotics-related arrests in FY 2017.Stop Opioid Abuse and Reduce Drug Supply and Demand introduced new measures to keep dangerous drugs out the United States.Signed the INTERDICT Act into law, enhancing efforts to detect and intercept synthetic opioids.DOJ secured its first-ever indictments against Chinese fentanyl manufacturers.DOJ launched their Joint Criminal Opioid Darknet Enforcement (J-CODE) team, aimed at disrupting online illicit opioid sales.Released an immigration framework that includes the resources required to secure our borders and close legal loopholes, and repeatedly called on Congress to fix our broken immigration laws.Authorized the deployment of the National Guard to help secure the border.Enhanced vetting of individuals entering the U.S. from countries that don’t meet security standards, helping to ensure individuals who pose a threat to our country are identified before they enter.These procedures were upheld in a June 2018 Supreme Court hearing.ICE removed over 226,000 illegal aliens from the United States in 2017.ICE rescued or identified over 500 human trafficking victims and over 900 child exploitation victims in 2017 alone.In 2017, ICE Enforcement and Removal Operations (ERO) arrested more than 127,000 aliens with criminal convictions or charges, responsible forOver 76,000 with dangerous drug offenses.More than 48,000 with assault offenses.More than 11,000 with weapons offenses.More than 5,000 with sexual assault offenses.More than 2,000 with kidnapping offenses.Over 1,800 with homicide offenses.Created the Victims of Immigration Crime Engagement (VOICE) Office in order to support the victims and families affected by illegal alien crime.More than doubled the number of counties participating in the 287(g) program, which allows jails to detain criminal aliens until they are transferred to ICE custody.TradeNegotiating and renegotiating better trade deals, achieving free, fair, and reciprocal trade for the United States.Agreed to work with the European Union towards zero tariffs, zero non-tariff barriers, and zero subsides.Deal with the European Union to increase U.S. energy exports to Europe.Litigated multiple WTO disputes targeting unfair trade practices and upholding our right to enact fair trade laws.Finalized a revised trade agreement with South Korea, which includes provisions to increase American automobile exports.Negotiated an historic U.S.-Mexico-Canada Trade Agreement to replace NAFTA.Agreement to begin trade negotiations for a U.S.-Japan trade agreement.Secured $250 billion in new trade and investment deals in China and $12 billion in Vietnam.Established a Trade and Investment Working Group with the United Kingdom, laying the groundwork for post-Brexit trade.Enacted steel and aluminum tariffs to protect our vital steel and aluminum producers and strengthen our national security.Conducted 82 anti-dumping and countervailing duty investigations in 2017 alone.Confronting China’s unfair trade practices after years of Washington looking the other way.25 percent tariff on $50 billion of goods imported from China and later imposed an additional 10% tariff on $200 billion of Chinese goods.Conducted an investigation into Chinese forced technology transfers, unfair licensing practices, and intellectual property theft.Imposed safeguard tariffs to protect domestic washing machines and solar products manufacturers hurt by China’s trade policiesWithdrew from the job-killing Trans-Pacific Partnership (TPP).Secured access to new markets for America’s farmers.Recent deal with Mexico included new improvements enabling food and agriculture to trade more fairly.Recent agreement with the E.U. will reduce barriers and increase trade of American soybeans to Europe.Won a WTO dispute regarding Indonesia’s unfair restriction of U.S. agricultural exports.Defended American Tuna fisherman and packagers before the WTOOpened up Argentina to American pork experts for the first time in a quarter-centuryAmerican beef exports have returned to china for the first time in more than a decadeOK’d up to $12 billion in aid for farmers affected by unfair trade retaliation.EnergyPresidential Memorandum to clear roadblocks to construction of the Keystone XL Pipeline.Presidential Memorandum declaring that the Dakota Access Pipeline serves the national interest and initiating the process to complete construction.Opened up the Alaska National Wildlife Refuge to energy exploration.Coal exports up over 60 percent in 2017.Rolled back the “stream protection rule” to prevent it from harming America’s coal industry.Cancelled Obama’s anti-coal Clean Power Plan and proposed the Affordable Clean Energy Rule as a replacement.Withdrew from the job-killing Paris climate agreement, which would have cost the U.S. nearly $3 trillion and led to 6.5 million fewer industrial sector jobs by 2040.U.S. oil production has achieved its highest level in American historyUnited States is now the largest crude oil producer in the world.U.S. has become a net natural gas exporter for the first time in six decades.Action to expedite the identification and extraction of critical minerals that are vital to the nation’s security and economic prosperity.Took action to reform National Ambient Air Quality Standards, benefitting American manufacturers.Rescinded Obama’s hydraulic fracturing rule, which was expected to cost the industry $32 million per year.Proposed an expansion of offshore drilling as part of an all-of-the above energy strategyHeld a lease sale for offshore oil and gas leases in the Gulf of Mexico in August 2018.Got EU to increase its imports of liquefied natural gas (LNG) from the United States.Issued permits for the New Burgos Pipeline that will cross the U.S.-Mexico border.Foreign PolicyMoved the U.S. Embassy in Israel to Jerusalem.Withdrew from Iran deal and immediately began the process of re-imposing sanctions that had been lifted or waived.Treasury has issued sanctions targeting Iranian activities and entities, including the Islamic Revolutionary Guard Corps-Qods ForceSince enacting sanctions, Iran’s crude exports have fallen off, the value of Iran’s currency has plummeted, and international companies have pulled out of the country.All nuclear-related sanctions will be back in full force by early November 2018.Historic summit with North Korean President Kim Jong-Un, bringing beginnings of peace and denuclearization to the Korean Peninsula.The two leaders have exchanged letters and high-level officials from both sides have met resulting in tremendous progress.North Korea has halted nuclear and missile tests.Negotiated the return of the remains of missing-in-action soldiers from the Korean War.Imposed strong sanctions on Venezuelan dictator Nicholas Maduro and his inner circle.Executive order preventing those in the U.S. from carrying out certain transactions with the Venezuelan regime, including prohibiting the purchase of the regime’s debt.Responded to the use of chemical weapons by the Syrian regime.Rolled out sanctions targeting individuals and entities tied to Syria’s chemical weapons program.Directed strikes in April 2017 against a Syrian airfield used in a chemical weapons attack on innocent civilians.Joined allies in launching airstrikes in April 2018 against targets associated with Syria’s chemical weapons use.New Cuba policy that enhanced compliance with U.S. law and held the Cuban regime accountable for political oppression and human rights abuses.Treasury and State are working to channel economic activity away from the Cuban regime, particularly the military.Changed the rules of engagement, empowering commanders to take the fight to ISIS.ISIS has lost virtually all of its territory, more than half of which has been lost under Trump.ISIS’ self-proclaimed capital city, Raqqah, was liberated in October 2017.All Iraqi territory had been liberated from ISIS.More than a dozen American hostages have been freed from captivity all of the world.Action to combat Russia’s malign activities, including their efforts to undermine the sanctity of United States elections.Expelled dozens of Russian intelligence officers from the United States and ordered the closure of the Russian consulate in Seattle, WA.Banned the use of Kaspersky Labs software on government computers, due to the company’s ties to Russian intelligence.Imposed sanctions against five Russian entities and three individuals for enabling Russia’s military and intelligence units to increase Russia’s offensive cyber capabilities.Sanctions against seven Russian oligarchs, and 12 companies they own or control, who profit from Russia’s destabilizing activities.Sanctioned 100 targets in response to Russia’s occupation of Crimea and aggression in Eastern Ukraine.Enhanced support for Ukraine’s Armed Forces to help Ukraine better defend itself.Helped win U.S. bid for the 2028 Summer Olympics in Los Angeles.Helped win U.S.-Mexico-Canada’s united bid for 2026 World Cup.DefenseExecutive order keeping the detention facilities at U.S. Naval Station Guantanamo Bay open.$700 billion in military funding for FY 2018 and $716 billion for FY 2019.Largest military pay raise in nearly a decade.Ordered a Nuclear Posture Review to ensure America’s nuclear forces are up to date and serve as a credible deterrent.Released America’s first fully articulated cyber strategy in 15 years.New strategy on national biodefense, which better prepares the nation to defend against biological threats.Administration has announced that it will use whatever means necessary to protect American citizens and servicemen from unjust prosecution by the International Criminal Court.Released an America first National Security Strategy.Put in motion the launch of a Space Force as a new branch of the military and relaunched the National Space Council.Encouraged North Atlantic Treaty Organization (NATO) allies to increase defense spending to their agree-upon levels.In 2017 alone, there was an increase of more than 4.8 percent in defense spending amongst NATO allies.Every member state has increased defense spending.Eight NATO allies will reach the 2 percent benchmark by the end of 2018 and 15 allies are on trade to do so by 2024.NATO allies spent over $42 billion dollars more on defense since 2016.Executive order to help military spouses find employment as their families deploy domestically and abroad.Veterans affairsSigned the VA Accountability Act and expanded VA telehealth services, walk-in-clinics, and same-day urgent primary and mental health care.Delivered more appeals decisions – 81,000 – to veterans in a single year than ever before.Strengthened protections for individuals who come forward and identify programs occurring within the VA.Signed legislation that provided $86.5 billion in funding for the Department of Veterans Affairs (VA), the largest dollar amount in history for the VA.VA MISSION Act, enacting sweeping reform to the VA system that:Consolidated and strengthened VA community care programs.Funding for the Veterans Choice program.Expanded eligibility for the Family Caregivers Program.Gave veterans more access to walk-in care.Strengthened the VA’s ability to recruit and retain quality healthcare professionals.Enabled the VA to modernize its assets and infrastructure.Signed the VA Choice and Quality Employment Act in 2017, which authorized $2.1 billion in addition funds for the Veterans Choice Program.Worked to shift veterans’ electronic medical records to the same system used by the Department of Defense, a decades old priority.Issued an executive order requiring the Secretaries of Defense, Homeland Security, and Veterans Affairs to submit a joint plan to provide veterans access to access to mental health treatment as they transition to civilian life.Increased transparency and accountability at the VA by launching an online “Access and Quality Tool,” providing veterans with access to wait time and quality of care data.Signed legislation to modernize the claims and appeal process at the VA.Harry W. Colmery Veterans Educational Assistance Act, providing enhanced educational benefits to veterans, service members, and their family members.Lifted a 15-year limit on veterans’ access to their educational benefits.Created a White House VA Hotline to help veterans and principally staffed it with veterans and direct family members of veterans.VA employees are being held accountable for poor performance, with more than 4,000 VA employees removed, demoted, and suspended so far.Signed the Veterans Treatment Court Improvement Act, increasing the number of VA employees that can assist justice-involved veterans.