At-Home OTC COVID-19 Diagnostic Tests

"At-home over-the-counter (OTC) COVID-19 diagnostic tests can show if you have an active COVID-19 infection.

These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations) without a prescription. Tests are available online or at local stores and  you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory.

With most at-home OTC COVID-19 diagnostic tests, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results.

For more information, including answers to frequently asked general questions about at-home COVID-19 diagnostic tests, visit At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.

Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates

The table below is updated regularly and lists FDA-authorized at-home OTC COVID-19 diagnostic tests, including information on expiration dates, who can use the test, links to home use instructions for each test, and other details that may help you decide what test is right for you. For additional information about each Emergency Use Authorization (EUA), see In Vitro Diagnostics EUAs: Tables of IVD EUAs.

In the table below, the "Expiration Date" column lists where to find the expiration date for that test, and the "Other Details" column lists the shelf-life for the test. The shelf-life is how long the test should work as expected and is measured from the date the test was manufactured. The expiration date is set at the end of the shelf-life and is the date through which the test is expected to perform as accurately as when manufactured. In some cases, the expiration date for a test may be extended.

An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized. For more information about how the expiration date is determined and why it may be extended, see the At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.   

To see if the expiration date for your at-home OTC COVID-19 test has been extended, first find the row in the below table that matches the manufacturer and test name shown on the box label of your test. If the expiration date has been extended, then the Expiration Date column states "Extended Expiration Date" and links to a document that lists the lot numbers, original expiration dates, and the extended expiration dates. If your lot number and/or original expiration date do not appear, or if the Expiration Date column states “Expiration Date: See box label,” do not use the test beyond the original expiration date on your test. 

Search the table below by manufacturer, test name, or other details shown in the table to find more information on the test, including if the expiration date has been extended. .."
OVID-19 Diagnostic Tests 

FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco Bars E-Cigarettes

"Today, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are disposable e-cigarettes that come in flavors known to appeal to youth, including bubblegum and cotton candy. 

“The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” said FDA Commissioner Robert M. Califf, M.D. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.” 

The warning letters were the result of a nationwide retailer inspection blitz over the past several weeks cracking down on the sale of these unauthorized e-cigarettes. The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.

In addition, two studies published today in the Centers for Disease Control and Prevention’s Morbidity & Mortality Weekly Report reinforce concerns about the risks of Elf Bar products among young people. The first study assessed retail sales of e-cigarettes, which typically align closely with patterns of youth use. This study found Elf Bar was the most popular disposable e-cigarette sold in the U.S. in December 2022. That study aligns with recent findings from the International Tobacco Control Survey, which found that as of August 2022, Elf Bar is the top disposable e-cigarette brand reported among persons ages 16 to 19 in the U.S. 

A second study showed thousands of e-cigarette exposure cases reported to U.S. poison centers in the past year, most of which were among kids younger than 5 years old. Among the limited number of cases with brand information reported from April 2022 to March 2023, Elf Bar was cited more than all other brands combined, with nearly all Elf Bar cases occurring among children younger than 5 years old.."
Elf Bar, Esco Bars and E-cigarettes 

At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative:

"The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or
serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.

At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19. At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polymerase chain reaction (PCR) tests. This is especially true early in an infection or in people who do not have COVID-19 symptoms. Currently, all at-home COVID-19 antigen tests are FDA-authorized for repeat, or serial use. This means people should use multiple tests over a certain time period, such as 2-3 days, especially when the people using the tests don't have COVID-19 symptoms. Today, the FDA is highlighting the continued need for repeat, or serial testing when people get a negative result with an at-home COVID-19 antigen test, including recommending additional testing over a longer period of time..."
At-Home COVI-19 Tests 

What Ingredients are in the COVID-19 Vaccine?

"Pfzer-BioNTech Vaccine

• 95% effective • Number of shots: 2 shots, 21 days apart
• Approved for use in people aged 16 years and older

• Ingredients:
messenger ribonucleic acid (mRNA), lipids (((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl) bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose •

Explanation of ingredients:
- Lipids: Nanolipids, or tiny fat molecules, protect the mRNA and provide a “greasy” exterior that helps the mRNA slide inside cells. Nanolipid components in the Pfzer-BioNTech vaccine include: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1- diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3- phosphocholine, and cholesterol -

Salts: Helping to balance the acidity in your body, the following salts are included in the Pfzer-BioNTech vaccine: potassium chloride, monobasic potassium phosphate, sodium chloride, and dibasic sodium phosphate dihydrate -

Sugar: Basic table sugar, also known as sucrose, can also be found in the Pfzer-BioNTech vaccine. This ingredient helps the molecules maintain their shape during freezing.
• Does NOT contain: Eggs, Preservatives, Latex
Learn more, read the FDA full Pfzer-BioNToNTech Fact Sheet:
www.fda.gov/media/144414/download

Moderna Vaccine

• 94% effective •
Number of shots: 2 shots, 28 days apart
•Approved for use in people aged 18 years and older

• Ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose

• Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna’s also uses mRNA technology to build antibodies against COVID-19. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient’s cells. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-snglycero-3-phosphocholine [DSPC]) - The remaining ingredients, including acids (acetic acid), acid stabilizers (tromethamine and tromethamine hydrochloride), salt (sodium acetate), and sugar (sucrose) all work together to maintain the stability of the vaccine after it’s produced.
• Does NOT contain: Eggs, Preservatives, Latex
Learn more, read the FDA full Moderna Fact Sheet:
www.fda.gov/media/144638/download.."
COVID-19 vaccine ingredients 

Personal Protective Equipment EUAs

"Personal Protective Equipment refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.

To help address concerns about availability during the COVID-19 pandemic, the FDA has issued EUAs for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators. Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an Interactive Review Template For Non-IVD Products. Additionally, the FDA has posted a Surgical Masks EUA Template for Addition to Appendix A of the Surgical Mask Umbrella EUA..."
Personal Protective Equipment 

Tracking COVID-19 Vaccines: U.S. Data Systems and Related Issues

"The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for two Coronavirus Disease 2019 (COVID-19) vaccines, sponsored by Pfizer-BioNTech and Moderna, and millions of vaccine doses are being distributed nationwide. Both vaccines require two doses, which are generally not interchangeable. Key to this effort, several existing and new data systems are in use to track, specifically,

 where the vaccines supply is: for example, whether vaccines are in a storage center or at a provider site, through the Vaccine Tracking System (VTrckS);
 who has received a vaccine: that is, recipients who have received one or both doses of which vaccine, through jurisdiction-based Immunization Information Systems (IIS); and
 if any new safety issues occur: several monitoring systems aim to identify new safety issues and inform public health recommendations or FDA actions.

The federal government has long supported data capabilities for vaccines, primarily through the Centers for Disease Control and Prevention (CDC). As with public health data generally, vaccine data systems use both federal and nonfederal (e.g., state-based) systems. For a number of years, 64 state, territorial, and local jurisdictions have received Immunization Cooperative Agreements (commonly referred to as “Section 317 grants”) administered by CDC. Among other functions, this flexible grant program has supported implementation of VTrckS for vaccine supply tracking and IISs for vaccine recipient tracking.

IISs (commonly referred to as immunization registries) enable both (1) consolidated immunization histories for a given individual, and (2) tracking of administered vaccines across the population. IISs also aid with vaccine reminders, including second-dose reminders. Most, but not all, jurisdictions have had IISs. New Hampshire created one for the COVID-19 vaccination program..."
COVID-19 Vaccinations 

Legal Issues in COVID-19 Vaccine Development and Deployment

"Private companies, universities, and governmental entities are working to develop a vaccine for coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with other information, to prepare a biologics license application (BLA) to submit to FDA. FDA approves the BLA if it determines that the vaccine is safe, potent, and pure.
 

 Because the development and review process can be lengthy, the FD&C Act provides several avenues to accelerate this process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track product and breakthrough-therapy designation at the sponsor’s request for products that are intended to fill an unmet need or improve existing therapies. Both designations entitle the sponsor to increased communication with FDA and rolling review of the BLA. Products may also qualify for accelerated approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. FDA may also designate products for priority review. Finally, in certain emergency situations, FDA may temporarily authorize the use of unapproved products or approved products for unapproved uses through an emergency use authorization (EUA). For FDA to issue an EUA, the Secretary of Health and Human Services (HHS) must determine that a qualifying emergency exists due to a biological, chemical, or nuclear agent that can cause a serious or life-threatening disease. The Secretary must also determine that it is reasonable to believe that the authorized product may treat or prevent the disease caused by the agent; the known and potential benefits outweigh the known and potential risks; and there are no approved, adequate, and available alternatives. Products authorized by an EUA may be marketed and used for the authorized use while the emergency persists unless FDA revokes the EUA. FDA may also modify or waive good manufacturing practice and prescription requirements in an EUA.
 

 FDA approval of a vaccine allows for its marketing, but does not guarantee that the vaccine will be widely available or affordable. Because patents grant inventors a temporary monopoly on a patented invention, patents may influence access to and the affordability of a COVID-19 vaccine. Federal agencies and funding support many of the COVID-19 vaccine candidates in development, which may affect the allocation and scope of patent rights, depending on the form of federal support and the terms of a vaccine developer’s contracts with the federal government. Under certain circumstances, the federal government can also exercise several legal authorities if patent rights limit the affordability of or access to a COVID19 vaccine. For vaccines developed with federal support, the government may secure upfront guarantees on pricing or distribution via funding or purchasing contracts with vaccine developers. For vaccines protected by patents subject to the Bayh-Dole Act, the funding agency could invoke “march-in rights” to enable other producers to manufacture the vaccine. For any U.S. patent, the federal government could use its “eminent domain” powers under 28 U.S.C. § 1498, which allows the government to make and use patented inventions without license, if reasonable compensation is provided to the patent holder..."
COVID-19 legal issues 

FDA Releases New Outbreak Investigation Table

"The U.S. Food and Drug Administration is committed to transparency and keeping the public and stakeholders informed of our work upholding the safety of our food supply. As part of this continued commitment, today we are releasing a new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation – prior to a public health advisory or recall of a certain food product being issued.

Today our FDA investigation team, the Coordinated Outbreak Response and Evaluation (CORE) Network, is starting the ongoing publication of a new investigation table that will include information on all foodborne outbreaks for which the FDA has initiated an investigation. The table, which will be updated on a weekly basis, will include information about each stage of an outbreak investigation. Currently, a public health advisory or recall is issued for any outbreak investigation that results in specific, actionable steps consumers can take to protect themselves such as a recommendation to not eat a certain type of food or recalled food product. This practice will remain the same..."
FDA investigation tool 

FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem

" FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested. FDA has identified the following products manufactured by Eskbiochem:

• All-Clean Hand Sanitizer (NDC: 74589-002-01)
• Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
• Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
• The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
• Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

FDA tested samples of Lavar Gel and CleanCare No Germ. Lavar Gel contains 81 percent (v/v) methanol and no ethyl alcohol, and CleanCare No Germ contains 28 percent (v/v) methanol. Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.

Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning..."
FDA and hand sanitizers

Legal Issues in COVID-19 Vaccine Development

"Private companies, universities, and governmental entities are working to develop a vaccine for coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with other information, to prepare a biologics license application (BLA) to submit to FDA. FDA approves the BLA if it determines that the vaccine is safe, potent, and pure.

Because the development and review process can be lengthy, the FD&C Act provides several avenues to accelerate this process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track product and breakthrough-therapy designation at the sponsor’s request for products that are intended to fill an unmet need or improve on existing therapies. Both designations entitle the sponsor to increased communication with FDA regarding the clinical trial design and data collected, as well as rolling review of the BLA. Products may also qualify for accelerated approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. In addition, FDA may designate products for priority review..."
COVID-19 Development

Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines

"In the race to develop a Coronavirus Disease 2019 (COVID-19) vaccine, several pharmaceutical companies, governments, and educational institutions around the world have begun testing their potential COVID-19 vaccines in clinical trials. Clinical trials are used to assess whether a new pharmaceutical product, such as a vaccine, is safe for humans and effective in achieving its intended purpose. Companies must generally test new pharmaceutical products on humans through clinical trials to obtain U.S. Food and Drug Administration (FDA) approval to market the product. But using human subjects to test these novel products exposes them to unknown health and safety risks, raising ethical considerations for FDA and for the sponsors and Institutional Review Boards (IRBs) overseeing the investigations. These stakeholders—sponsors, IRBs, and FDA—aim to balance the need to ensure that the product is safe and effective against the desire to bring the product to market quickly, tensions that are heightened during a worldwide pandemic. Existing law requires FDA and IRBs to weigh these considerations when evaluating proposed clinical trial designs for COVID-19 vaccines.

This Sidebar describes the legal and regulatory framework that governs clinical trials for pharmaceutical products, such as vaccines, and some avenues researchers and Congress may consider for accelerating that process during the COVID-19 pandemic. (For ease of reference, this Sidebar uses the term drugs includes both traditional drugs and biological products, including vaccines.).."
Testing and clinical trails

FDA Launches Searchable Purple Book

"The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book.

Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names (proprietary and proper), the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentation, license status, BLA number and approval date.

Biopharma companies previously requested that FDA include exclusivity information in the Purple Book, similar to what’s offered in the Orange Book, and FDA says that a later iteration of the database will include such dates...
Purple Book"
Purple Book

Right to Try: Access to Investigational Drugs

"The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try (RTT) Act of 2017 became federal law on May 30, 2018. Over the preceding five years, 40 states had enacted related legislation. The goal was to allow individuals with imminently life-threatening diseases or conditions to seek access to investigational drugs without the step of procuring permission from the Food and Drug Administration (FDA). Another goal—held by the Goldwater Institute, which led the initiative toward state bills, and some of the legislative proponents—was focused more on the process: to eliminate government’s role in an individual’s choice.

The RTT Act (P.L. 115-176) offers eligible individuals and their physicians a pathway other than FDA’s expanded access procedures to acquiring investigational drugs. It defines an eligible patient as one who (1) has been diagnosed with a life-threatening disease or condition, (2) has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (as certified by a physician who meets specified criteria), and (3) has given written informed consent regarding the drug to the treating physician..."
Investigatiional drugs

Warning Letters and Civil Money Penalties Issued to Retailers for Selling JUUL and Other E-Cigarettes to Minors

"June 2018 – September 2018

In the largest coordinated enforcement effort in the FDA's history, the agency issued more than 1,300 warning letters and civil money penalty complaints (fines) to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer:

• See sample warning letter (PDF - 168 KB)
• Retailers who received 1,300+ warning letters and civil money penalty complaints (fines) (CSV)

April 2018 – June 2018

FDA issued warning letters (PDF) and civil money penalties (CMPs) in April - June 2018 as part of a concerted effort to ensure youth are not able to access these products. These retailers sold e-cigarettes—including JUUL products—to minors..."
E-Cigarettes

FDA Regulation of Medical Devices

"Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical device regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system..."
Medical devices regulation

Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use

"The Food and Drug Administration (FDA, we, or the Agency) is issuing
 this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA...."
Antimicrobial soaps

FDA’s New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

"Tobacco use is the single largest preventable cause of disease and death in the United States. Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products. For background information on this milestone in consumer protection, see The Facts on the FDA’s New Tobacco Rule.

Read the FDA Voice blog post by Center Director Mitch Zeller on Protecting the Public and Especially Kids from Tobacco Products, Including E-Cigarettes, Cigars and Hookah Tobacco..."
E-Cigarettes

Food Labeling: Revision of the Nutrition and Supplement Facts Labels

"The FDA today finalized the new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The new label will make it easier for consumers to make better informed food choices..."
Food label

Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah

"Tobacco use is the single largest preventable cause of disease and death in the United States. As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product.

Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule – Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.

This action is a milestone in consumer protection – going forward, the FDA will be able to:

• Review new tobacco products not yet on the market;
• Help prevent misleading claims by tobacco product manufacturers;
• Evaluate the ingredients of tobacco products and how they are made; and
• Communicate the potential risks of tobacco product..."

Tobacco products

FDA proposes limit for inorganic arsenic in infant rice cereal

"The U.S. Food and Drug Administration is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults.  Moreover, national intake data show that people consume the most rice (relative to their weight) at approximately 8 months of age.

Through a draft guidance to industry, the FDA is proposing a limit or “action level” of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal. This is parallel to the level set by the European Commission (EC) for rice intended for the production of food for infants and young children. (The EC standard concerns the rice itself; the FDA’s proposed guidance sets a draft level for inorganic arsenic in infant rice cereal.) FDA testing found that the majority of infant rice cereal currently on the market either meets, or is close to, the proposed action level..."
Inorganic arsenic & rice cereal