The following are given passages.
Passage 1:
Marketed Health Products Directorate
The Marketed Health Products Directorate (MHPD) is the Canadian federal authority that monitors the safety and effectiveness of health products marketed in Canada. These include:
Prescription and non-prescription medications
Biologic medical products, including fractionated blood products
Therapeutic and diagnostic vaccines
Natural health products;
Radiopharmaceutical products
Medical devices
Cells, tissues and organsAs part of Health Canada, MHPD collects and analyzes reports of adverse health product reactions through its network of regional reporting centres and disseminates new health product safety information.
Passage 2:
Blood substitute
A blood substitute (also called artificial blood or blood surrogate) is a substance used to mimic and fulfill some functions of biological blood. It aims to provide an alternative to blood transfusion, which is transferring blood or blood-based products from one person into another. Thus far, there are no well-accepted oxygen-carrying blood substitutes, which is the typical objective of a red blood cell transfusion; however, there are widely available non-blood volume expanders for cases where only volume restoration is required. These are helping doctors and surgeons avoid the risks of disease transmission and immune suppression, address the chronic blood donor shortage, and address the concerns of Jehovah's Witnesses and others who have religious objections to receiving transfused blood.
The main categories of "oxygen-carrying" blood substitutes being pursued are hemoglobin-based oxygen carriers (HBOC) and perfluorocarbon emulsions. Oxygen therapeutics are in clinical trials in the U.S. and European Union, and Hemopure is available in South Africa.

History
After William Harvey discovered blood pathways in 1616, many people tried to use fluids such as beer, urine, milk, and non-human animal blood as blood substitute. Sir Christopher Wren suggested wine and opium as blood substitute.At the beginning of the 20th century, the development of modern transfusion medicine initiated through the work of Landsteiner and co-authors opened the possibility to understanding the general principle of blood group serology.  Simultaneously, significant progress was made in the fields of heart and circulation physiology as well as in the understanding of the mechanism of oxygen transport and tissue oxygenation.Restrictions in applied transfusion medicine, especially in disaster situations such as World War II, laid the grounds for accelerated research in the field of blood substitutes. Early attempts and optimism in developing blood substitutes were very quickly confronted with significant side effects, which could not be promptly eliminated due to the level of knowledge and technology available at that time. The emergence of HIV in the 1980s renewed impetus for development of infection-safe blood substitutes. Public concern about the safety of the blood supply was raised further by mad cow disease. The continuous decline of blood donation combined with the increased demand for blood transfusion (increased ageing of population, increased incidence of invasive diagnostic, chemotherapy and extensive surgical interventions, terror attacks, international military conflicts) and positive estimation of investors in biotechnology branch made for a positive environment for further development of blood substitutes.Efforts to develop blood substitutes have been driven by a desire to replace blood transfusion in emergency situations, in places where infectious disease is endemic and the risk of contaminated blood products is high, where refrigeration to preserve blood may be lacking, and where it might not be possible or convenient to find blood type matches.In 2023, DARPA announced funding twelve universities and labs for synthetic blood research. Human trials would be expected to 2028~2030.

Approaches
Efforts have focused on molecules that can carry oxygen, and most work has focused on recombinant hemoglobin, which normally carries oxygen, and perfluorocarbons (PFC), chemical compounds which can carry and release oxygen.The first approved oxygen-carrying blood substitute was a perfluorocarbon-based product called Fluosol-DA-20, manufactured by Green Cross of Japan. It was approved by the Food and Drug Administration (FDA) in 1989. Because of limited success, complexity of use and side effects, it was withdrawn in 1994. However, Fluosol-DA remains the only oxygen therapeutic ever fully approved by the FDA.  As of 2017 no hemoglobin-based product had been approved.

Perfluorocarbon based
Perfluorochemicals are not water soluble and will not mix with blood, therefore emulsions must be made by dispersing small drops of PFC in water. This liquid is then mixed with antibiotics, vitamins, nutrients and salts, producing a mixture that contains about 80 different components, and performs many of the vital functions of natural blood. PFC particles are about 1/40 the size of the diameter of a red blood cell (RBC). This small size can enable PFC particles to traverse capillaries through which no RBCs are flowing. In theory this can benefit damaged, blood-starved tissue, which conventional red cells cannot reach. PFC solutions can carry oxygen so well that mammals, including humans, can survive breathing liquid PFC solution, called liquid breathing.Perfluorocarbon-based blood substitutes are completely man-made; this provides advantages over blood substitutes that rely on modified hemoglobin, such as unlimited manufacturing capabilities, ability to be heat-sterilized, and PFCs' efficient oxygen delivery and carbon dioxide removal. PFCs in solution act as an intravascular oxygen carrier to temporarily augment oxygen delivery to tissues. PFCs are removed from the bloodstream within 48 hours by the body's normal clearance procedure for particles in the blood – exhalation. PFC particles in solution can carry several times more oxygen per cubic centimeter (cc) than blood, while being 40 to 50 times smaller than hemoglobin.Fluosol was made mostly of perfluorodecalin or perfluorotributylamine suspended in an albumin emulsion. It was developed in Japan and first tested in the United States in November 1979. In order to "load" sufficient amounts of oxygen into it, people who had been given it had to breathe pure oxygen by mask or in a hyperbaric chamber. It was approved by the FDA in 1989, and was approved in eight other countries. Its use was associated with a reduction in ischemic complications and with an increase in pulmonary edema and congestive heart failure.  Due to difficulty with the emulsion storage of Fluosol use (frozen storage and rewarming), its popularity declined and its production ended in 1994.
Oxygent was a second-generation, lecithin-stabilized emulsion of a PFC that was under development by Alliance Pharmaceuticals.   In 2002 a Phase III study was halted early due an increase in incidences of strokes in the study arm.

Haemoglobin based
Haemoglobin is the main component of red blood cells, comprising about 33% of the cell mass. Haemoglobin-based products are called haemoglobin-based oxygen carriers (HBOCs).Unmodified cell-free haemoglobin is not useful as a blood substitute because its oxygen affinity is too high for effective tissue oxygenation, the half-life within the intravascular space that is too short to be clinically useful, it has a tendency to undergo dissociation in dimers with resultant kidney damage and toxicity, and because free haemoglobin tends to take up nitric oxide, causing vasoconstriction.Efforts to overcome this toxicity have included making genetically engineered versions, cross-linking, polymerization, and encapsulation.HemAssist, a diaspirin cross-linked haemoglobin (DCLHb) was developed by Baxter Healthcare; it was the most widely studied of the haemoglobin-based blood substitutes, used in more than a dozen animal and clinical studies.   It reached Phase III clinical trials, in which it failed due to increased mortality in the trial arm, mostly due to severe vasoconstriction complications.   The results were published in 1999.Hemolink (Hemosol Inc., Mississauga, Canada) was a haemoglobin solution that contained cross-linked an o-rafinose polymerised human haemoglobin. Hemosol struggled after Phase II trials were halted in 2003 on safety concerns and declared bankruptcy in 2005.Hemopure was developed by Biopure Corp and was a chemically stabilized, cross-linked bovine (cow) haemoglobin in a salt solution intended for human use; the company developed the same product under the trade name Oxyglobin for veterinary use in dogs.  Oxyglobin was approved in the US and Europe and was introduced to veterinary clinics and hospitals in March 1998. Hemopure was approved in South Africa and Russia. Biopure filed for bankruptcy protection in 2009. Its assets were subsequently purchased by HbO2 Therapeutics in 2014.PolyHeme was developed over 20 years by Northfield Laboratories and began as a military project following the Vietnam War. It is human haemoglobin, extracted from red blood cells, then polymerized, then incorporated into an electrolyte solution. In April 2009, the FDA rejected Northfield's Biologic License Application and in June 2009, Northfield filed for bankruptcy.Dextran-Haemoglobin was developed by Dextro-Sang Corp as a veterinary product, and was a conjugate of the polymer dextran with human haemoglobin.Hemotech was developed by HemoBiotech and was a chemically modified haemoglobin.
Somatogen developed a genetically engineered and crosslinked tetramer it called Optro. It failed in a phase II trial that was published in 2014 and development was halted.A pyridoxylated Hb conjugated with polyoxyethylene was created by scientists at Ajinomoto and eventually developed by Apex Biosciences, a subsidiary of Curacyte AG; it was called "PHP" and failed in a Phase III trial published in 2014, due to increased mortality in the control arm, which led to Curacyte shutting down.Similarly, Hemospan was developed by Sangart, and was a pegylated haemoglobin provided in a powdered form. While early trials were promising Sangart ran out of funding and closed down.

Stem cells
Stem cells offer a possible means of producing transfusable blood. A study performed by Giarratana et al. describes a large-scale ex-vivo production of mature human blood cells using hematopoietic stem cells. The cultured cells possessed the same haemoglobin content and morphology as native red blood cells. The authors contend that the cells had a near-normal lifespan, when compared to natural red blood cells.Scientists from the experimental arm of the United States Department of Defense began creating artificial blood for use in remote areas and transfuse blood to wounded soldiers more quickly in 2010. The blood is made from the hematopoietic stem cells removed from the umbilical cord between human mother and newborn using a method called blood pharming. Pharming has been used in the past on animals and plants to create medical substances in large quantities. Each cord can produce approximately 20 units of blood. The blood is being produced for the Defense Advanced Research Projects Agency by Arteriocyte. The Food and Drug Administration has examined and approved the safety of this blood from previously submitted O-negative blood. Using this particular artificial blood will reduce the costs per unit of blood from $5,000 to equal or less than $1,000. This blood will also serve as a blood donor to all common blood types.

See also
Artificial Cells, Blood Substitutes, and Biotechnology
Blood plasma substitute (disambiguation)
Blood transfusion
Bloodless surgery
Erythromer
Induced blood stem cells
Respirocyte
Theatrical blood
Passage 3:
Over-the-counter drug
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription.  In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products.  By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription. In contrast, prescription drugs require a prescription from a doctor or other health care professional and should only be used by the prescribed individual. Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient's needs or the provision of patient education. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country.

Usage
As of 2011, around a third of older adults in the U.S. reportedly used OTC drugs, and this number is increasing. By 2018, the prevalence of use by adults in the U.S. as first-line treatment for minor illnesses had reached 81%, however there is some debate as to whether this figure relates to an actual improvement of health.

Regulation by country
Canada
In Canada, there are four drug schedules:
Schedule 1: Requires a prescription for sale and is provided to the public by a licensed pharmacist.
Schedule 2: Does not require a prescription but requires an assessment by a pharmacist prior to sale. These drugs are kept in an area of the pharmacy where there is no public access and may also be referred to as "behind-the-counter" drugs.
Schedule 3: Does not require a prescription but must be kept in an area under the supervision of a pharmacist. These drugs are kept in an area of the retail outlet where self-selection is possible, but a pharmacist must be available to assist in the self-selection of medication if required.
Unscheduled: Does not require a prescription and may be sold in any retail outlet.All medications other than Schedule 1 may be considered an OTC drug, as they do not require prescriptions for sale. While the National Association of Pharmacy Regulatory Authorities provides recommendations on the scheduling of drugs for sale in Canada, each province may determine its own scheduling. The drugs found in each schedule may vary from province to province.

India
In November 2016, India's Drug Consultative Committee announced it was embarking on establishing a definition of drugs which could be dispensed without a prescription. Prior to this, the general assumption was that any drug which did not fall into a prescription schedule could be purchased without a prescription.  However, the needed definition had not been enacted by early 2018. The lack of a legal definition for OTC drugs has led to this US$4 billion market segment being effectively unregulated.

Netherlands
In the Netherlands, there are four categories:
UR (Uitsluitend Recept): prescription only
UA (Uitsluitend Apotheek): pharmacist only
UAD (Uitsluitend Apotheek of Drogist): pharmacist or drugstore only
AV (Algemene Verkoop): may be sold in general storesA drug that is UA may be sold OTC but only by pharmacists. The drug can be on the shelves like any other product. Examples are domperidone, 400 mg ibuprofen up to 50 tablets and dextromethorphan. A drug that is UAD can also be sold at drugstores which are stores where no prescription can be filled. The drugs are usually on the shelves, and the store also sells items like toys, gadgets, perfumes and homeopathic products. The drugs in this category have limited risk and addiction potential. Examples are naproxen and diclofenac in small amounts, cinnarizine, 400 mg ibuprofen up to 20 tablets and also 500 mg paracetamol up to 50 tablets. Drugs in the AV category can be sold at supermarkets, gas stations, etc. and include only drugs with minimal risk to the public, like paracetamol up to 20 tablets, 200 mg ibuprofen up to 10 tablets, cetirizine and loperamide.

United States
In the United States, the manufacture and sale of OTC substances are regulated by the Food and Drug Administration. The FDA requires that all "new drugs" obtain a New Drug Application (NDA) before entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective (GRAS/E). To deal with the vast number of OTC drugs that were already on the market before the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and to categorize them as GRAS/E after review by expert panels. Certain classes of OTC drugs would not be required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings finalized in the Code of Federal RegulationsThus, an OTC drug product is allowed to be marketed either (1) pursuant to an FDA monograph or (2) pursuant to an NDA for products that do not fit within a specific monograph. There is also the possibility that certain OTC drug products are marketed under the grandfathering provisions of the Federal Food, Drug, and Cosmetic Act, but the FDA has never formally acknowledged that any legitimate grandfathered OTC drug exists.
Examples of OTC substances approved in the United States are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine and aspirin, psoriasis and eczema topical treatments, anti-dandruff shampoos containing coal tar, and other topical products with a therapeutic effect.
The Federal Trade Commission regulates advertising of OTC products, in contrast to prescription drug advertising, which is regulated by the FDA.The FDA requires OTC products to be labeled with an approved "Drug Facts" label to educate consumers about their medications. The labels comply to a standard format and are intended to be easy for typical consumers to understand. Drug Facts labels include information on the product's active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients.The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes reforms that modernize the way certain OTC drugs are regulated in the United States. Many OTC monographs need to be updated but updating or changing an OTC monograph requires the slow and burdensome notice-and-comment rulemaking process. The CARES Act includes OTC monograph reform provisions that replace the rulemaking process with an administrative order process.

Restricted over-the-counter substances
An ill-defined third category of substances is products having over-the-counter status from the FDA while being simultaneously subject to other restrictions on sale. While they are legally classified as OTC drugs, they are typically stored behind the counter and are sold only in stores that are registered with their state. They may be unavailable in convenience and grocery stores that stock other non-restricted OTC medications.
For example, many drugstores have moved products containing pseudoephedrine, an OTC product, into locations where customers must ask a pharmacist for them. A prescription is not required; the change has been made in an effort to reduce methamphetamine production. Since the passage of the Illinois Methamphetamine Precursor Control Act and the subsequent federal Combat Methamphetamine Epidemic Act of 2005, the purchase of pseudoephedrine is restricted. Sellers of pseudoephedrine must obtain and record the identity of the purchaser and enforce quantity restrictions. After initial attempts to control methamphetamine use (by requiring documentation of sale with government issued ID as well as limits on the quantity an individual could purchase) failed to realize meaningful reductions in methamphetamine use and production, Mississippi passed House Bill 512 in the State Senate on February 2, 2010 "to require a prescription from a licensed medical professional to purchase over-the-counter medicines with pseudoephedrine, ephedrine, or any other precursor chemical that can readily and illicitly be converted into methamphetamine, Methcathinone or any active/scheduled analogs of Phenylethylamines/ amphetamine." However, products containing the substance are still OTC in most states, since no prescription is required.

A similar regulation once applied to some forms of emergency contraception. However, on February 25, 2014, the FDA approved generic one-pill emergency contraception products for unrestricted sale on the shelf. There is no age limit or need for ID to purchase.Furthermore, some Schedule V controlled substances may be classified as OTC products in certain states. Such drugs are sold without a prescription but are subject to record-keeping rules and quantity and/or age restrictions, and they must be dispensed by a pharmacy. Finally, pharmacies frequently require a prescription for Schedule V drugs as a matter of policy, despite their OTC status according to applicable laws and regulations.

United Kingdom
In the United Kingdom, medication is governed by the Medicines Regulations 2012. Medication falls into one of three categories:
Prescription Only Medication (POM), which are legally available only with a valid prescription from a prescriber. A pharmacist has to be on the premises for POM medicines to be dispensed, required by law. The medicine has been specifically prescribed for the patient holding the prescription, so it is considered safe for only the recipient to take. Just a small example of these include most antibiotics and all antidepressants or antidiabetic medications. Certain POM medicines are additionally marked Controlled Drug (CD) due to risk of abuse and the possibility of diversion for sale as street drugs. Examples of CDs include all benzodiazepines and strong opioids such as heroin and fentanyl.
General Sales List (GSL), available off the shelf with no pharmacy training required to sell (so they can be sold anywhere, such as supermarkets). In general, they are considered safe for most people when taken correctly. Examples of these include 16-packs (or less) of painkillers such as paracetamol, ibuprofen, and aspirin as well as a host of other medications such as small pack sizes of some antihistamines, some laxative medication, and skin creams. Also includes the recreational substances alcohol, caffeine, and some nicotine preparations.
Pharmacy Medicines (P) are medicines that are legally neither a POM or GSL medication. These can be sold from a registered pharmacy but should not be available for self-selection (although directions to discuss a 'P' product may be allocated shelf space with associated GSL items). 'P' medications are reserved from the GSL list as they are either associated with a need for advice on use, or used in conditions which may require referral to a medical prescriber. Suitable trained counter assistants may sell a 'P' medication under the supervision of a pharmacist and will ask questions to determine if the customer needs to be referred for a discussion with a pharmacist. Some 'POM' medicines are available for use in certain situations and doses as 'P' medicines.If it is not appropriate to sell a 'P' medication – i.e. the condition is not suitable for self-management and requires referral to a medical prescriber – then a sale should not occur and the pharmacist has a legal and professional obligation to refer this on to an appropriate service.
Examples of these include some sleep aid tablets such as diphenhydramine, human deworming tablets such as Mebendazole, painkillers with small amounts of codeine (up to 12.8 mg per tablet), and pseudoephedrine. Medication available only with a prescription is marked somewhere on the box/container with [POM]. Pharmacy-only products are marked with [P]. A prescription is not required for [P] medicines, and pharmacy sales assistants are required by Royal Pharmaceutical Society codes to ask certain questions, which varies for what the customer says. If they ask for a specific product, the pharmacy assistant must ask "Who is it for," "How long have you had the symptoms," "Are you allergic to any medication," "Are you taking any medication" ('WHAM' questions). If a customer asks for a remedy, e.g., hay fever, then the two WHAM questions must be followed "Who is it for," "What are the symptoms," "How long have you had the symptoms," "Have you taken any action towards your symptoms," and "Are you taking any other medication." It is with this information that the pharmacist can halt the sale, if need be. No [POM], [P] or [GSL] products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises. Some medication available in supermarkets and petrol stations is sold only in smaller packet sizes. Often, larger packs will be marked as [P] and available only from a pharmacy. Frequently, customers buying larger-than-usual doses of [P] medicines (such as DXM, promethazine, codeine or Gee's Linctus) will be queried, due to the possibility of abuse.

Transitions between prescription and OTC
As a general rule, over-the-counter drugs have to be used primarily to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well tolerated. OTC drugs are usually also required to have little or no abuse potential, although in some areas drugs such as codeine are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase).Over time, often 3–6 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC. An example of this is diphenhydramine (Benadryl), an anti-histamine which once required a prescription but now is available OTC nearly everywhere. More recent examples are cimetidine and loratadine in the United States, and ibuprofen in Australia.It is somewhat unusual for an OTC drug to be withdrawn from the market as a result of safety concerns, rather than market forces, though it does happen occasionally. For example, phenylpropanolamine was removed from sale in the United States over concern regarding strokes in young women. A study has been done examining consumer's perceptions about the risk of and access to nonprescription medication. The study concluded that a small percentage of consumers prefer having access to medication over potential risks of taking non-prescribed medication. Ranitidine was suspended in multiple markets due to concerns over the presence of the carcinogen N-nitrosodimethylamine (NDMA).In the United Kingdom, it was announced in February 2007 that Boots the Chemist would try over-the-counter sales of Viagra in stores in Manchester, England (previous available as prescription only). Men aged between 30 and 65 could buy four tablets after a consultation with a pharmacist.

See also
Passage 4:
FDA Food Safety Modernization Act
The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.
The law was prompted after many reported incidents of foodborne illnesses during the first decade of the 2000s and was largely crafted by members of the Grocery Manufacturers Association. Tainted food has cost the food industry billions of dollars in recalls, lost sales and legal expenses.
This bill is similar to the Food Safety Enhancement Act which passed the House in 2009. It is considered the first major piece of federal legislation addressing food safety since 1938. It is also the first piece of legislation to address intentional adulteration and Food Defense.

Background
The U.S. Centers for Disease Control and Prevention (CDC) estimated in 2011 that each year 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. 31 pathogens are notorious for causing foodborne illness. Unspecified agents have insufficient data to estimate with certainty the agent-specific burden. Known agents that have not been identified as causing foodborne illness include microbes, chemicals, or other substance known to be in food. The ability for these known agents to cause illness has not been proven so they remain unidentified. 
Considering that about 30% of the population is at risk for food borne sicknesses, over 14% of food supply to the United States is imported from other countries, and also new and more food items are becoming more complex or intricate, the FSMA was indeed needed.
 The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It enables the FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.
In 1998, the FDA announced a publication entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" in response to President Clinton's 1997 "Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables". They resulted in Good Agricultural Practices (GAP) and Good Handling Practices (GHP) certifications that became de facto industry requirements, but were not enforceable.High-profile outbreaks related to various foods, from spinach and peanut products to eggs, have underscored the need to make continuous improvements in food safety.
Under this law the FDA will be allowed to mandate a system that is based on science and addresses the hazards from farm to table. This means that the FDA has the power to oversee how foods are produced and how they are maintained in food markets. This puts greater emphasis on preventing food-borne illness. The reasoning is simple: The better the system handles producing, processing, transporting, and preparing foods, the safer our food supply will be.Under the new law, the FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in their approach to food safety. For example, for the first time, the FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain. Preventive controls include steps that a food facility would take to prevent or significantly minimize the likelihood of problems occurring. The new law also significantly enhances the FDA's ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year.

Legislative history
The events of September 11, 2001, reinforced the need to enhance the security of the United States. Congress responded by passing the Public Health Security and Bioterrorism Preparedness Response Act, "The Bioterrorism Act," which President Bush signed into law June 12, 2002.
The Bioterrorism Act of 2002 granted the FDA administrative detention authority over food items if there is credible evidence or information that indicates the food presents a threat of serious adverse health consequences or death to humans or animals. The new (FSMA) law broadens that authority, allowing for administrative detention based on ‘reason to believe’ that the food item has been misbranded or adulterated’ and thus violates a legal standard for the product.

The first version of the law, the Food Safety Enhancement Act, passed the House on June 9, 2009. However, negotiations with the Senate led to the final product, the "Food Safety and Modernization Act." The bill was passed by the Senate in November 2010 by a vote of 73–25. However, because of a tax provision added to the bill, (which is constitutionally required to begin in the House), the vote did not count. There was concern that with the short time left in the lame-duck session, the bill would not get the time needed to be voted on and passed. Attempts to add the bill to the continuing resolution for government funding were scrapped over the objection of Senator Tom Coburn. Eventually, however, the Senate moved on December 19, 2010, to pass the fixed bill by unanimous consent by a voice vote. The House went on to approve the bill by a vote of 215 to 144 on December 21, 2010. President Barack Obama signed the bill into law on Tuesday, January 4, 2011.Although this bill is meant to address food safety, there are, according to food safety advocate Bill Marler, some issues with its effectiveness. Many facilities, such as farms, restaurants, and nonprofit food establishments in which food is prepared for or served directly to the consumer are exempt from the requirements of the bill. Also exempt are facilities that produce food solely for non-human animals.

Tester-Hagan Amendment
Senators Jon Tester and Kay Hagan sponsored two amendments that removed farmers, ranchers and local processors from federal oversight, leaving them—as they currently are—within the existing regulatory framework of state and local health and sanitation laws and rules.The amendment offered protections for operations (a.k.a. “qualified facilities”) that sell less than $500,000 a year and sell most (greater than 50%) of their products directly to consumers in the same state and within a 400-mile radius. The amendment also applies to all operations that the FDA classified as a "very small business." Small, local farmers would not necessarily need to comply with some of the requirements and produce safety regulations implemented under S. 510. Instead, these small-scale producers (like those who sell their goods at farmers' markets or roadside stands) would continue to be regulated by local and state entities. In addition, consumers would know whom they are buying from either by direct sales or clear labeling.Farmers who qualify must provide documentation that the farm is in compliance with state regulations. Documentation may include licenses, inspection reports, or other evidence that the farm is in compliance with State, local, county, or other applicable non-Federal food safety law. The farm must also prominently and conspicuously display the name and address of farm/facility on its label. For foods without a label then by poster, sign, or placard, at the point of purchase or, in the case of Internet sales, in an electronic notice, or in the case of sales to stores and restaurants, on the invoice.

Provisions
Impact and fees
The legislation affects every aspect of the U.S. food system, from farmers to manufacturers to importers. It places significant responsibilities on farmers and food processors to prevent contamination—a departure from the country's reactive tradition, which has relied on government inspectors to catch tainted food after the fact The legislation requires food producers and importers to pay an annual $500 registration fee, which would help fund stepped-up FDA inspections, enforcement and related activities such as food-safety research
About 360,000 facilities in the United States and abroad would be subject to the fees. The Congressional Budget Office reported that the fees would not cover the cost of the new system, leaving the FDA to incur a net cost of $2.2 billion over five years.

Prevention
For the first time, the FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply, including pet food and animal feed.

Mandatory preventive controls for food facilities
Food facilities are required to implement a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise. Animal food manufacturers must implement current Good Manufacturing Practices and Preventive Controls.(Final rule published September 17, 2015)Mandatory produce safety standards
The FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. (Final regulation due about 2 years following enactment)Radiological hazards
For the first time, firms must explicitly consider radioactive contamination as part of their hazard analysis, under chemical safety. The FDA does not anticipate that this will be a hazard that requires continuous monitoring with a Geiger counter. Rather, as an example, a firm that uses spring water in its products should consider having the water tested regularly for the presence of dissolved radon, tritium and heavy metal contaminants.Authority to prevent intentional contamination
The FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. (Final rule due 18 months following enactment) This is the first time language involving Food Defense has been incorporated into law.

Inspection and compliance
The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. FSMA provides the FDA with new authority to conduct inspections and ensure compliance.

Mandated inspection frequency
The FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs the FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. To accomplish this projected goal, the USFDA and other agencies in the United States will work in partnership or collaborate with foreign governing bodies for help, due to lack of resources to meet the demand.Records access
FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.Testing by accredited laboratories
The FSMA requires certain food testing to be carried out by accredited laboratories and directs the FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards. (Establishment of accreditation program due 2 years after enactment)Visual inspection
During an unannounced inspection by the FDA, a visual inspection will be conducted.  During the inspection they will look at the building and equipment to see if there is any possibility of food contamination.  The will probe into poor welds, condensation leaks especially over open product lines.Swabbing of environment
During their cursory walk, the agent will also look for any areas and niches that they feel may be a harborage point for bacteria.  The agents can and will take anywhere form 150- 200 swabs depending on how big the facility is.  The agent will also take raw material samples as well as finished product.  It is advised that the company does not take companion samples because this can double the chances of a lab error, and does not look good if the FDA's samples come up negative and the facilities positive and vice versa.

Response to contaminants/violations
The bill gives the FDA the authority to recall food in the case of contamination or illness. In addition, it requires farms to track their food and implement plans to deal with recalls or outbreaks of disease. FDA officials will also be given access to food growers records in the case of an outbreak. The bill also requires food importers to verify that they meet US food safety standards. Small farms that sell locally or sell less than $500,000 a year are exempt from these new rules. New authorities include:

Mandatory recall
The FSMA provides the FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by the FDA.
Expanded administrative detention
The FSMA provides the FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law (administrative detention is the procedure the FDA uses to keep suspect food from being moved).
Suspension of registration
The FDA can suspend registration of a facility if it determines that the food poses a SOMEWHAT reasonable probability of serious adverse health consequences or death. A facility that is under suspension is prohibited from distributing food. (Effective 6 months after enactment)Enhanced product tracing abilities
The FDA is directed to establish a system that will enhance its ability to track and trace both domestic and imported foods. In addition, FDA is directed to establish pilot projects to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or control a food borne illness outbreak. (Implementation of pilots due 9 months after enactment)Additional Record keeping for High Risk Foods
The FDA is directed to issue proposed rule making to establish record keeping requirements for facilities that manufacture, process, pack, or hold foods that the Secretary designates as high-risk foods. (Implementation due 2 years after enactment).

Additional information on imported goods
The FSMA gives the FDA authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers, with the vision that imported foods should be held to the same standards as domestic foods. These standards will be met by implementing the following components:

Importer accountability
For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)Third Party Certification
The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for the FDA to recognize accreditation bodies is due 2 years after enactment)Certification for high risk foods
The FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.Voluntary qualified importer program
The FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)Authority to deny entry
The FDA can refuse entry into the U.S. of food from a foreign facility if the FDA is denied access by the facility or the country in which the facility is located.

Enhanced partnerships
The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. In doing so, the statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals. The following are examples of enhanced collaboration:

State and local capacity building
The FDA must develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies. The FSMA provides the FDA with a new multi-year grant mechanism to facilitate investment in State capacity to more efficiently achieve national food safety goals.Foreign capacity building
The law directs the FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries. One component of the plan is to address training of foreign governments and food producers on U.S. food safety requirements.Reliance on inspections by other agencies
The FDA is explicitly authorized to rely on inspections of other Federal, State and local agencies to meet its increased inspection mandate for domestic facilities. The FSMA also allows the FDA to enter into inter-agency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.

Employee protections
The FSMA also includes provisions that protect employees who try to prevent food safety problems. Section 402 of the FSMA prohibits employers engaged in the manufacture, processing, packing, transporting, distribution, reception, holding or importation of food from retaliating against employees who disclose violations of the Federal Food, Drug, and Cosmetic Act. This particular portion of the FSMA is administered by the U.S. Department of Labor.

Implementation
With the Act in place, the FDA began the rulemaking process to codify how to enforce the new laws.Effective June 12, 2011, many food companies became required to develop food safety plans based on an evaluation of hazards related to food manufactured, processed, packed or held in all registered facilities. Following a hazard analysis, firms were required to identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards. Examples of preventive controls include sanitation procedures for food contact surfaces; employee hygiene training; environmental monitoring to verify pathogen controls; a recall plan; supplier verification activities; and a food allergen control program.Even after completion of the rulemaking process, it was estimated that time would be required for the FDA to become fully equipped to enforce the new laws. The agency estimated that it would require at least 1,000 more inspectors and $1.4 billion over the following five years, with uncertainty that Congress would appropriate such funds given the economic climate at the time, and calls for spending cuts.

Rules
In 2012, the FDA was sued by consumer groups the Center for Food Safety (CFS) and the Center for Environmental Health for its failure to meet deadlines. In settling the litigation, the agency agreed to deadlines in 2015 and 2016 for certain rules.The first public comment period occurred in 2013, and the agency received tens of thousands of comments in that period. The FDA previously submitted their proposed regulations to the Office of Management and Budget (OMB) for review, and in that process the OMB weakened the regulations in a variety of ways.

FSMA progress report
The FDA has planned to make available to the general public and to Congress significant progress they have made towards implementing the FSMA. In March 2012, the FDA's Senior Advisor, Coordinated Outbreak Response and Evaluation Network, Sherri McGarry, on a blog reported the types of foods to be used in the pilot project on tracing products to prevent illnesses. The list includes tomatoes, frozen Kung Pao-style dishes, jarred peanut butter, and dry, packaged peanut/spice. Tomatoes both sliced and whole were chosen because of the significant number of outbreaks recorded; mirroring a multifaceted food supply chain. It was recommended by majority of the food industry associations as the number one food product to be used in the pilot program.The Frozen Kung Pao-style dishes contain ingredients such as chicken, red pepper spice and peanut products which are foods that are involved in outbreaks, and for this reason were included in the pilot project. In addition, it is supplied to diverse food chain distribution channels which could involve imported and domestic products. To increase the intricacy of the pilot project, the jarred peanut butter and dry, packaged spice peanut were included. That summer, the pilot projects results were expected to be accomplished with hopes of developing a complete product tracing system with the information received.

Funding
The Safety Act was signed into law along with the Government Performance and Results Modernization Act of 2010. The cost for the first five years was projected to be $1.4 billion, without being fully funded at that time.

Food facility registration
On October 22, 2012, the updated food facility registration system by the US FDA was made available. This update required all facilities previously registered prior to October 1, 2012, to renew registration. Failure to do so became a prohibited act, leading to refusal of entry for foreign products and illegal trade for domestic facilities. Every 2 years in even numbered years, every registered facility would be required to renew its registration between October 1 and December 31. Registration would be accepted by fax, mail and electronics means on the FDA food facility registration website.
As of January 22, 2014, there were 195,518 food facilities registered with the FDA.

Reaction and controversy
Large trade organizations joined public health advocates in supporting the bill, while groups aligned with individuals and small farms generally opposed it. However, after Senate adoption of Jon Tester's amendment, which allows for the possible exemption of producers that sell less than $500,000 a year, many large food companies objected, arguing that the exemption puts consumers at risk.A year after enactment the agency had fallen behind on expected progress. It has yet to implement "a specific timetable for issuing" a process to create rule for science-based produce standards, has not completed rules for foreign supplier verification, and must still create a guidance that will help schools and childcare programs lessen allergy risks for school-age children.A similar set of New Zealand rules, Food Bill 160-2, has been towards passage since 2010. The primary effects expected are to tie New Zealand to Codex Alimentarius and the World Trade Organization permanently, although those international agreements will be constantly adjusted. Despite its 366 pages, Food Bill 160-2 cannot directly resolve many threats to food safety, as there is no added Produce traceability nor methods to control Antibiotic resistance. Controversy has been intense in NZ regarding introduction of genetically-engineered plants and animals (GE); concern is that WTO and Codex will require opening up NZ to GE. The Soil & Health Association of New Zealand would not be able to complete their campaign towards making New Zealand organic by 2020.

Alcoholic beverage facilities exemption
There has been criticism that the FDA's proposed rule would be prohibitively expensive on the practice of alcoholic beverage facilities selling spent grain to farmers for animal food. Under current law, alcoholic beverages, such as beer, wine, cider and spirits, are exempt from the FDA's normal oversight of food products. The FDA will open up the rule to comments again this summer and then revise the proposal, which is due to be finalized by August 2015.The proposed rules regulate the "good manufacturing practice in manufacturing, processing, packing or holding of animal food" and "require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals", but animal food at alcoholic beverage facilities would not be exempt pursuant to section 116 of FSMA since "those spent grains are not alcoholic beverages themselves, and they are not in a prepackaged form that prevents any direct human contact with the food".As of September 18, 2018, all brewers need to be in compliance with the Food Safety Modernization Act (FSMA).
Under the final rules the FDA is obligated to inspect every brewery in the USA over the next few years.
The FDA inspector will inspect and observe every level of the brewers operations.
They may and will review all record keeping files and are allowed to make copies and photographs for their records.
If the brewing facility fails the FDA inspection they will not only get fined but a stricter re-inspection will be required at a cost of over $200 per hour payable by the inspected brewer.
The USA brewing industry is legally obliged to provide a safe for consumption product and to ensure safety throughout the supply and manufacturing chain.
Brewing beer generally creates a much safer product than non-alcoholic beverages and foods, naturally protected from certain mycotoxins and bacteria, however it can still be contaminated by foreign bodies and chemicals at various stages within the manufacturing process.

See also
Codex Alimentarius
Food Bill 160-2 of New Zealand
Passage 5:
Pure Food and Drug Act
The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.
In the late 1800s, the quality of food in the United States decreased significantly as populations moved to cities and the time from farm to market increased. Many food producers turned to using dangerous preservatives, even formaldehyde, to keep food fresh. Simultaneously, the quality of medicine was abysmal. Quack medicine was frequent, and many drugs were addictive or dangerous without actually providing a curative effect. Opium and alcohol were chief ingredients, even in infant medicines. The work of muckraking journalists exposed the horrific practices of both industries and caused public outcry.
Foremost among such exposés was The Jungle by Upton Sinclair, published the same year as the act. With its graphic and revolting descriptions of unsanitary conditions and unscrupulous practices rampant in the meatpacking industry, it was an inspirational piece that kept the public's attention on the important issue of unhygienic meat processing plants.  Sinclair quipped, "I aimed at the public's heart and by accident I hit it in the stomach," as outraged readers demanded and got the Pure Food and Drug Act, as well as the 1906 Federal Meat Inspection Act.

Historical significance
The Pure Food and Drug Act of 1906 was a key piece of Progressive Era legislation, signed by President Theodore Roosevelt on the same day as the Federal Meat Inspection Act. Enforcement of the Pure Food and Drug Act was assigned to the Bureau of Chemistry in the U.S. Department of Agriculture which was renamed the U.S. Food and Drug Administration (FDA) in 1930. The Meat Inspection Act was assigned to what is now known as the Food Safety and Inspection Service, which remains in the U.S. Department of Agriculture. The first federal law regulating foods and drugs, the 1906 Act's reach was limited to foods and drugs moving in interstate commerce. Although the law drew upon many precedents, provisions, and legal experiments pioneered in individual states, the federal law defined "misbranding" and "adulteration" for the first time and prescribed penalties for each. The law recognized the U.S. Pharmacopeia and the National Formulary as standards authorities for drugs, but made no similar provision for federal food standards. The law was principally a "truth in labeling" law designed to raise standards in the food and drug industries and protect the reputations and pocketbooks of honest businessmen.

Particular drugs deemed addictive
Under the law, drug labels, for example, had to list any of 10 ingredients that were deemed "addictive" and/or "dangerous" on the product label if they were present, and could not list them if they were not present. Alcohol, morphine, opium, and cannabis were all included on the list of these "addictive" and/or "dangerous" drugs. The law also established a federal cadre of food and drug inspectors that one Southern opponent of the legislation criticized as "a Trojan horse with a bellyful of inspectors and other employees." Penalties under the law were modest, but an under-appreciated provision of the Act proved more powerful than monetary penalties. Goods found in violation of various areas of the law were subject to seizure and destruction at the expense of the manufacturer. That, combined with a legal requirement that all convictions be published as Notices of Judgment, proved to be important tools in the enforcement of the statute and had a deterrent effect upon would-be violators.Deficiencies in this original statute, which had become noticeable by the 1920s, led to the replacement of the 1906 statute with the Federal Food, Drug, and Cosmetic Act which was enacted in 1938 and signed by President Franklin Roosevelt. This act, along with its numerous amendments, remains the statutory basis for federal regulation of all foods, drugs, biological products, cosmetics, medical devices, tobacco, and radiation-emitting devices by the U.S. Food and Drug Administration.

History of passage
An 1882 article in Scientific American describes "New Laws for Analyzing Food and Drugs" and highlights historical aspects. Part of the draft stated:"An article shall be deemed to be adulterated within the meaning of this act.A.-In the case of drugs:* If, when sold under or by a name recognized in the United States Pharmacopeia, it differs from the standard of strength, quality, or purity laid down in such work.* If when sold under or by a name not recognized in the United States Pharmacopeia, but which is found in some other pharmacopeia or ether standard work on materia medica, it differs from the standard of strength, quality, or purity laid down in such work.* If its strength or purity fall below the professed standard under which it is soldB.-In the case of food or drink:* If any substance or substances has or have been mixed with it as to reduce or lower or injuriously affect its quality of strength* If any inferior or cheaper substance or substances have been substituted wholly or in part for the article*If any valuable constituent of the article has been wholly or is part abstracted* If it be an imitation of or be sold under the name of another article* If it consists wholly or in part of a diseased or decomposed, or putrid or rotten, animal or vegetable substance, whether manufactured or not, or in the case of milk, if it is the produce of a diseased animal* If it be colored, or coated, or polished, or powdered, whereby damage is concealed, or it is made to appear better than it really is, or of greater value"―Scientific American, 7 Jan 1882
It took 27 years to adopt the 1906 statute, during which time the public was made aware of many problems with foods and drugs in the U.S. Muckraking journalists, such as Samuel Hopkins Adams, targeted the patent medicine industry with its high-alcoholic content patent medicines, soothing syrups for infants with opium derivatives, and "red clauses" in newspaper contracts providing that patent medicine ads (upon which most newspapers of the time were dependent) would be withdrawn if the paper expressed support for food and drug regulatory legislation.
The Chief Chemist of the Bureau of Chemistry, Dr. Harvey Washington Wiley, captured the country's attention with his hygienic table studies, which began with a modest Congressional appropriation in 1902. The goal of the table trial was to study the human effects of common preservatives used in foods during a period of rapid changes in the food supply brought about by the need to feed cities and support an industrializing nation increasingly dependent on immigrant labor. Wiley recruited young men to eat all their meals at a common table as he added increased "doses" of preservatives including borax, benzoate, formaldehyde, sulfites, and salicylates. The table trials captured the nation's fancy and were soon dubbed "The Poison Squad" by newspapers covering the story. The men soon adopted the motto "Only the Brave dare eat the fare" and at times the publicity given to the trials became a burden. Though many results of the trial came to be in dispute, there was no doubt that formaldehyde was dangerous and it disappeared quickly as a preservative. Wiley himself felt that he had found adverse effects from large doses of each of the preservatives and the public seemed to agree with Wiley. In many cases, most particularly with ketchup and other condiments, the use of preservatives was often used to disguise insanitary production practices. Although the law itself did not proscribe the use of some of these preservatives, consumers increasingly turned away from many products with known preservatives.
The 1906 statute regulated food and drugs moving in interstate commerce and forbade the manufacture, sale, or transportation of poisonous patent medicines. The Act arose due to public education and exposés from public interest guardians such as Upton Sinclair and Samuel Hopkins Adams, social activist Florence Kelley, researcher Harvey W. Wiley, and President Theodore Roosevelt.

Beginnings of the Food and Drug Administration
The 1906 Act paved the way for the eventual creation of the Food and Drug Administration (FDA) and is generally considered to be that agency's founding date, though the agency existed before the law was passed and was not named FDA until later. "While the Food and Drug act remains a foundational law of the FDA mission, it's not the law that created the FDA. [Initially,] the Bureau of Chemistry (the precursor to the FDA) regulated food safety. In 1927, the Bureau was reorganized into the Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils. The FDIA was renamed the FDA in 1930."The law itself was largely replaced by the much more comprehensive Federal Food, Drug, and Cosmetic Act of 1938.

Enforcement of labeling and future ramifications
The Pure Food and Drug Act was initially concerned with ensuring products were labeled correctly. Later efforts were made to outlaw certain products that were not safe, followed by efforts to outlaw products which were safe but not effective. For example, there was an attempt to outlaw Coca-Cola in 1909 because of its excessive caffeine content; caffeine had replaced cocaine as the active ingredient in Coca-Cola in 1903. In the case United States v. Forty Barrels and Twenty Kegs of Coca-Cola, the judge found that Coca-Cola had a right to use caffeine as it saw fit, although Coca-Cola eventually lost when the government appealed to the Supreme Court. It reached a settlement with the United States government to reduce the caffeine amount.
In addition to caffeine, the Pure Food and Drug Act required that drugs such as alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold as patent medicines with secret ingredients or misleading labels. Cocaine, heroin, cannabis, and other such drugs continued to be legally available without prescription as long as they were labeled. It is estimated that sale of patent medicines containing opiates decreased by 33% after labeling was mandated. The Pure Food and Drug Act of 1906 is cited by drug policy reform advocates such as Jim Gray as a successful model for re-legalization of currently prohibited drugs by requiring accurate labels, monitoring of purity and dose, and consumer education.
Passage 6:
List of Walmart brands
Walmart, Inc., like many large retail and grocery chain stores, offers private brands.

Apparel brands
Major brands
In March 2018, to better compete with Amazon and Target, Walmart introduced three new clothing lines and revamped an existing clothing line.
George – men's casual and dress clothing, shoes, and accessories (previously also women's and children's)
Terra & Sky – plus size women's clothing
Time and Tru – misses size women's clothing, shoes, and accessories
Wonder Nation – children's clothing, shoes, and accessories
K Alexander – Men's Accessories

Other brands
Athletic Works – men's, women's, and children's activewear
Brahma – men's and women's work boots
EV1 – women's casual clothing, accessories, and shoes endorsed by American television personality Ellen DeGeneres
No Boundaries, often abbreviated as NOBO – junior size women's and young men's clothing, shoes, and accessories
Joyspun – women's sleepwear and intimates

Major brands
Sam's Choice
Sam's Choice, originally introduced as Sam's American Choice in 1991, is a retail brand in food and selected hard goods. Named after Sam Walton, founder of Walmart, Sam's Choice forms the premium tier of Walmart's two-tiered core corporate grocery branding strategy that also includes the larger Great Value brand of discount-priced staple items.Compared to Great Value products and to other national brands, Sam's Choice is positioned as a premium retail brand and is offered at a price competitive with standard national brands. It typically offers either competitive items in a given product category, or items in categories where the market leader is an "icon" (for example, Coca-Cola in the soft drink category).
Most Sam's Choice beverage products (excluding Grapette and Orangette) are manufactured for Walmart by Cott Beverages. Other products in the line, including cookies, snack items, frozen meals, and similar grocery items, are made by a variety of agricultural and food manufacturers.
Competitive pricing of the Sam's Choice brand and store-branded and generic goods is possible because of the lower expense required to market a retail chain's house brand, compared to advertising and promotional expenses typically incurred by the national brands.
Most Sam's Choice-branded products have been replaced by either the relaunched Great Value brand, or the new Marketside brand. The brand was reintroduced in 2013 with a new logo and a focus on premium food products with organic ingredients.

Great Value
Great Value was launched in 1993 (but products were made as early as 1992) and forms the second tier, or national brand equivalent ("NBE"), of Walmart's grocery branding strategy.Products offered through the Great Value brand are often claimed by Walmart to be as good as national brand offerings, but are typically sold at a lower price because of lower marketing and advertising expense. As a house or store brand, the Great Value line does not consist of goods produced by Walmart, but is a labeling system for items manufactured and packaged by a number of agricultural and food corporations, such as ConAgra, and Sara Lee which, in addition to releasing products under its own brand and exclusively for Walmart, also manufactures and brands foods for a variety of other chain stores. Often, this labeling system does not list location of manufacture of the product. Walmart contends that all Great Value products are produced in the United States. Otherwise, the country of origin would be listed.
As Walmart's most extensively developed retail brand, covering hundreds of household consumable items, the Great Value line includes sliced bread, frozen vegetables, frozen dinners, canned foods, light bulbs, trash bags, buttermilk biscuits, cinnamon rolls, pies, and many other traditional grocery store products. The wide range of items marketed under the Great Value banner makes it Walmart's top-selling retail brand.
The Great Value brand can also be seen in Canada, Costa Rica, Honduras, Nicaragua, El Salvador, Mexico, Argentina, Chile, and Brazil and some Trust Mart stores in Hunza Pakistan, through a partnership with Walmart but China is not included anywhere. Bharti EasyDay retail grocery stores sell Great Value brand products in India as well. Great Value brand products as well as Walmart merchandise are also present in Seiyu grocery stores (owned by Walmart) in Tokyo, Japan as of October 2014, despite at least one report of a transition away from the brand.In 2009, the Great Value labels were redesigned to be predominantly white. The new redesign also includes over 80 new items, including thin-crust pizza, fat-free caramel swirl ice cream, strawberry yogurt, organic cage-free eggs, double-stuffed sandwich cookies, and teriyaki beef jerky. Walmart changed the formulas for 750 items, including: breakfast cereal, cookies, yogurt, laundry detergent, and paper towels. Great Value went through another redesign in 2013 for most of its food items, replacing predominantly white designs with more colorful packaging.

Equate
Equate is a brand used by Walmart for consumable pharmacy and health and beauty items, such as shaving cream, skin lotion, over-the-counter medications, and pregnancy tests. Before its takeover by Walmart, the formerly independent Equate brand sold consumer products at both Target and Walmart at lower prices than those of name brands. Equate is an example of the strength of Walmart's private label store brand. In a 2006 study, The Hartman Group marketing research firm issued a report which found that "Five of the top 10 "likely to purchase" private label brands are managed by Walmart including: Great Value, Equate, Sam's Choice, Walmart, and Member's Mark (Sam's Club), per the study." The report further noted that "...we are struck by the magnitude of mind-share Walmart appears to hold in shoppers' minds when it comes to awareness of private label brands and retailers."In mid-2010, the brand underwent a logo redesign, as well as packaging changes similar to the Great Value brand.

Mainstays
Mainstays is a brand marketed by Walmart for bedding, kitchen utensils, ready-to-assemble furniture, and home decor. Walmart also has the Better Homes & Gardens brand of home goods and furniture.

Ol' Roy
Ol' Roy is Walmart's store brand of dog food, created in 1983 and named after Sam Walton's dog. It has become the number-one selling brand of dog food in the United States. It is comparable to Nestlé's Purina.In 1998, samples of Ol' Roy (together with various other brands) were subject to qualitative analyses for pentobarbital residue by the U.S. Food and Drug Administration Center for Veterinary Medicine due to suspicion that the anesthetizing drug may have found its way into pet foods through euthanized animals. Pentobarbital was found in 5 out of the 8 Ol' Roy samples in the initial survey. The highest level of pentobarbital detected among all dog foods tested was an Ol' Roy formulation (Puppy Formula, Chicken and Rice) at 32ppb. The CVM concluded this level of pentobarbital would be unlikely to cause adverse effects even to the smallest dogs.

Special Kitty
Special Kitty is Walmart's store brand of cat food and other cat care products, such as litter and treats.

Parent's Choice
Parent's Choice is Walmart's store brand; including diapers, formula, and accessories. Like other Walmart store brands, its design and packaging was relaunched in 2010. Parent's Choice is manufactured by Wyeth, a pharmaceutical company that is a subsidiary of Pfizer. On October 15, 2009, representatives of Pfizer signed the final acquisition papers, making Wyeth a wholly owned subsidiary of that company, thus completing the US$68-billion dollar deal.

Play Day
Play Day is a wide-ranging brand of budget-priced children's toys. Play Day launched in between mid-2014 and early-2015, as a replacement brand for Kid Connection.

Pen+Gear
Pen+Gear is Walmart's store brand for school and office supplies. From notebooks, pens, markers, paper, binders, pencils and even paper shredders. Pen+Gear replaced the brand name Casemate in late 2016.

Additional brands
Homelines
Better Homes and Gardens is a product line with designs inspired from the popular magazine of the same name. It forms the premium tier to the Mainstays home brand, producing goods such as furniture, kitchen products, bedding, curtains and window blinds, decor, and other home products.
Hometrends products include small furniture, tableware and various home decor accessories, such as rugs and faux plants. (Discontinued in USA market)
Mainstays Kids
Your Zone is a home product line that tailors toward teenagers and college students.

Others
Adventure Force − toys suitable for outdoor use. Products include waterarms (water blaster guns).
Allswell, a luxury bedding and mattress brand owned by Walmart, but only sold direct to consumer
AutoDrive – car care products, auto detailing products, interior accessories and some low price exterior accessories such as license plate frames
Best Occasions – party decorations and accessories, such as candles and hats
Bike Shop - bicycle tires, tubes, and accessories
Clear American – carbonated and flavored water. Was previously known as Sam's Choice Clear American
Co Squared, a cosmetics brand owned by Walmart, but only sold direct to consumer
ColorPlace – paint and painting tools. ColorPlace paint is made by PPG
Douglas – budget priced tires. Models include Xtra-Trac and Touring. Some models are made in a Goodyear plant.
Earth Spirit - shoes
EverStart is the brand for automotive and lawn mower batteries. The brand is also used for battery-related accessories, such as jumper cables. EverStart batteries are manufactured by Johnson Controls, Inc., (who also manufactures batteries for other store brands) primarily at plants in Saint Joseph, Missouri, and Fort Wayne, Indiana.
Expert Grill – grills, charcoal, and grilling accessories (Replaced Backyard Grill)
Fire Side Gourmet – pre-cooked burgers and steaks (was previously under the Sam's Choice label)
Gold's Gym – athletic and exercise equipment such as weights. Named after and licensed from the chain of fitness centers.
Hart - power tools and outdoor power equipment
Holiday Time – Christmas items such as Christmas trees, decorations, and wrapping paper
Home Bake Value – bread
Hyper Tough – hand tools, hardware and storage, some power tools (power tool lineup is gradually being replaced by Hart)
Kid Connection is used primarily for children's toys, but was also used for children's clothing and shoes.
Marketside – fresh foods usually found in Walmart's deli, produce, and bakery departments, such as salads, soups, breads, and sandwiches
Mash-Up Coffee (Walmart-exclusive) – luxury coffee beans
Motile - laptops, miscellaneous tech, and tech accessories
Oak Leaf – low-cost wines produced and bottled for Walmart selling at approximately $3 a bottle.
Onn (stylized as onn.) – consumer electronics, computer accessories, audio/visual accessories, and phone/tablet accessories
Our Finest/Notre Excellence is a brand for upscale chips, cookies, frozen dinners, etc. which are sold exclusively in Canada. This brand is comparable to World Table and is manufactured in Canada exclusively for Walmart Canada.
Overpowered – pre-built gaming desktops and laptops
Ozark Trail – outdoor equipment and footwear. (The Walmart Home Office is located in the Ozark mountain region in northwest Arkansas.)
Price First/Prix Budget – entry-level everyday products, similar to Great Value, but generally at the lowest price point
Protege – luggage and travel accessories
ReliOn – diabetes care products, including blood glucose and blood pressure monitors, as well as medical thermometers, portable humidifiers and replacement filters for both ReliOn and name brand humidifiers
Spark Imagine - simple children's toys made with high-quality materials; comparable to Melissa and Doug
SuperTech is Walmart's brand of motor oil. Oil for both gasoline and diesel engines is sold under the SuperTech brand. The brand is also used on other consumable automotive products, such as oil filters, windshield wiper fluid, and transmission fluid.
Tasty - kitchen tools (Walmart exclusive under license from BuzzFeed)
The Office – office supplies and stationery
Uniquely J, a brand under Walmart's Jet.com website
Walmart Family Mobile is Walmart's exclusive prepaid mobile phone (cell phone) service provided through the T-Mobile cellular network.
World Table – upscale salsa, pizza, chips, cookies, etc., which are manufactured exclusively for Walmart and fancier than the Great Value entry
WAY TO CELEBRATE! – holidays such as Halloween, Valentine's Day, and St. Patrick's Day are manufactured exclusively at Walmart

Former brands
Backyard Grill – grills, charcoal, and grilling accessories (Discontinued)
Durabrand was a brand used for home electronics, such as televisions and DVD players. The brand was also used on various small kitchen appliances.
iLo Technologies was another brand of home electronics, consisting of more upscale items such as televisions, small electronics and digital music players.
Blackweb were premium electronics products; discontinued after a rebranding of the Onn line in 2020.
Canopy was a home product line for rooms and other domestic goods. The brand was replaced by the Better Homes and Gardens line in 2012.
Casemate was Walmart's school and office supplies brand in 2015. In late 2016, it was replaced by Pen+Gear.
Faded Glory was an apparel brand for women, men, and children. It was replaced by Time & Tru (for women), George (for men), and Wonder Nation (for children) in 2018.
Metro 7 was an upscale brand of women's apparel that was originally released in the fall of 2006 and eventually was discontinued.
Price First was a bottom-tier, low-priced generic brand that Walmart introduced in late 2013. It included very basic grocery items, trash bags, and paper goods. It was launched as an experimental brand targeted towards the most budget-conscious shoppers. It was the lowest priced brand at Walmart and availability varied by stores. Some of the grocery items included milk (which is often brand-name milk with a Price First label, as is Great Value milk), bread, granulated sugar, canned fruit/vegetables, boxed brownie mix, toaster pastries, elbow pasta, egg noodles, spaghetti, and skillet meals. Non-grocery items included paper towels, toilet tissue, trash bags, and food storage bags. The brand was discontinued in 2016.
Promark was a brand for tools in the 1980s and early 1990s. It was replaced by Popular Mechanics branding.
Puritan was a brand for men's basic clothing, including shirts, pants, undergarments, socks, ties, and some accessories. In late 2010, the brand was discontinued and replaced by Faded Glory (with undergarments, socks and casual clothing) and George (with ties, shirts, pants and formal clothing).
725 Originals was a brand at Walmart Canada that targeted teens. It was consolidated into the George label in 2010.[1]
Dr Thunder was a brand of soft drink produced for Walmart stores. It was originally called "Southern Lightning", but the name was changed to reflect its similarities to Dr Pepper. Since 2009, Walmart has sourced their store brand sodas from multiple companies, having previously exclusively used Cott Beverages as its manufacturer. The soda, as with all Walmart store brands, is also carried by Asda stores in the UK.

See also
Big-box store
Niagara Bottling

Answer the question based on the given passages. Only give me the answer and do not output any other words.

Question: The food safety system of the agency that has the authority to decide if a drug is marketed otc or prescription is known as?



Answer: Food Safety Modernization Act (FSMA)