[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

SCVNews.com | Is It Really ‘FDA Approved?’ | 01-17-2017
Inside
Weather
Santa Clarita CA
Sunny
Sunny
85°F
 
Calendar
Today in
S.C.V. History
July 25
1915 - Pioneer Juan Batista Suraco buried in a family graveyard, currently unmarked, in Bouquet Canyon near Benz Road [story]


“FDA approved!”

Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?

FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

But not all those products undergo premarket approval — that is, a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.

Here is a guide to how FDA regulates products — and what the agency does (and doesn’t) approve.

FDA doesn’t approve companies.

FDA does not “approve” health care facilities, laboratories, or manufacturers. FDA does have authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.
Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with FDA, unless an exemption applies. Blood and tissue facilities also must register with the agency.

Mammography facilities must be FDA certified and must display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards for providing quality mammography.

FDA approves new drugs and biologics.

New drugs and certain biologics must be proven safe and effective to FDA’s satisfaction before companies can market them in interstate commerce. Some examples of biologics that require approval are therapeutic proteins, vaccines, cellular therapies, and blood and blood products. Manufacturers must also prove they are able to make the drug product according to federal quality standards.
FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.

See the directory of approved and unapproved finished drugs on the market.

FDA doesn’t approve compounded drugs.

Compounding is generally a practice in which a pharmacist or a doctor combines ingredients to create medications that meet the needs of individual patients, including those who are allergic to ingredients in FDA-approved medicines or who cannot swallow an FDA-approved pill. But consumers need to be aware that compounded drugs are not FDA approved. This means that FDA does not review applications for compounded drugs to evaluate their safety, effectiveness, or quality

FDA uses a risk-based, tiered approach for regulating medical devices.

FDA classifies devices according to risk. The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.
Generally, FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.

Devices that present a low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements.

FDA uses a risk-based approach for human cells and tissues.

All human cells and tissues intended for use in humans — collectively referred to as human cells, tissues, and cellular and tissue based products — are regulated to prevent the transmission of infectious disease. Those that pose an additional risk also require FDA approval before marketing. Examples of cells and tissues include bone, skin, corneas, ligaments, tendons, dura mater, heart valves, and reproductive tissue.

FDA doesn’t approve tobacco products.

There’s no such thing as a safe tobacco product, so FDA’s safe and effective standard for evaluating medical products is not appropriate for tobacco products. Instead, FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole.
To legally sell or distribute a new tobacco product in the United States, manufacturers must receive a written order from FDA. There are three pathways are available to bring a tobacco product to market: premarket tobacco applications, substantial equivalence applications, or exemption from substantial equivalence.

A marketing order does not indicate that the tobacco product is either safe or “approved.” It means that the manufacturer has complied with the requirements under the law to bring its product to market.

FDA approves food additives in food for people.

Although FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in foods. Those include food additives, such as substances added intentionally to food, and color additives.
Companies that want to add new food additives to food are responsible for providing FDA with information demonstrating that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the food additive is safe for its intended use. An approved food additive must be used in compliance with its approved uses, specifications, and restrictions.

Some food additives are food contact substances that could migrate into food, such as coatings, plastics, paper and adhesives, as well as colorants, antimicrobials, and antioxidants found in packaging. They undergo a different review process. The same safety standards still apply, but the food contact notification process is specific to the identified manufacturer or supplier. If at the end of the review period FDA does not object, the food contact notification becomes effective and the food contact substance may be legally marketed.

Certain food ingredients, such as those that are considered “generally recognized as safe” (GRAS) by scientific experts, do not require premarket approval as a food additive. FDA has a voluntary notification process under which a manufacturer may submit a conclusion that the use of an ingredient is GRAS.

FDA approves color additives used in FDA-regulated products.

This includes those used in food (including animal food), dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency, and each must be used only in compliance with its approved uses, specifications, and restrictions.
In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.

FDA approves animal drugs and approves food additives for use in food for animals.

FDA is responsible for approving drugs for animals, including pets, livestock, and poultry. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)
Although FDA does not approve animal foods, including pet food, for marketing, it does approve food additives used in these products. FDA works to help ensure that food for animals (which includes livestock and poultry food, pet food and pet treats) is safe, made under sanitary conditions, and properly labeled.

The Preventive Controls for Animal Food rule, a new regulation mandated by the FDA Food Safety Modernization Act (FSMA), requires food companies to take steps to prevent foods from being contaminated and to use current good manufacturing practices (such as hygienic personnel practices, adequate sanitation practices, and proper equipment use) when making food for animals.

FDA does not approve cosmetics.

Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval before they go on the market. There’s one exception: color additives (other than coal-tar hair dyes). Cosmetics must be safe for their intended use and properly labeled.

FDA doesn’t approve medical foods.

A medical food is used for the dietary management of a disease or health condition that requires special nutrient needs. An example of a medical food is a food for use by persons with phenylketonuria, a genetic disorder. A person with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine. A medical food is intended for use under the supervision of a physician. It doesn’t include products such as meal replacements or diet shakes, or products for the management of diseases like diabetes, which can be managed through modification of the normal diet.
Medical foods do not have to undergo premarket approval by FDA. But medical food companies must comply with other requirements, such as good manufacturing practices and registration of food facilities. Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and not misleading.

FDA doesn’t approve infant formula.

FDA does not approve infant formulas before they can be marketed. But manufacturers of infant formula are subject to FDA’s regulatory oversight.
Manufacturers must ensure that infant formula complies with federal nutrient requirements. Manufacturers must register with FDA and provide the agency with a notification before marketing a new formula.

FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. FDA also inspects new facilities. If FDA determines that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

FDA doesn’t approve dietary supplements.

Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Unless an exception applies, dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before Oct. 15, 1994) require a notification to FDA at least 75 days before marketing.
The notification must include the information that provides the manufacturer’s or distributor’s basis for concluding that the dietary supplement will reasonably be expected to be safe. When public health concerns arise about a dietary supplement after the product is on the market, FDA evaluates the product’s safety through research and adverse event monitoring.

FDA doesn’t approve the food label, including the Nutrition Facts panel.

FDA does not approve individual food labels before food products can be marketed. But FDA regulations require nutrition information to appear on most foods, including dietary supplements. Also, any claims on food products must be truthful and not misleading, and must comply with any regulatory requirements for the type of claim.
Manufacturers must provide the serving size of the food and specified information about the nutrient content of each serving on the “Nutrition Facts” panel of the food label (or on the “Supplement Facts” panel for dietary supplements).

FDA doesn’t approve structure-function claims on dietary supplements and other foods.

Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is “calcium builds strong bones.”
Dietary supplement companies that make structure-function claims on labels or in labeling must submit a notification to FDA. This notification must be submitted no later than 30 days after first marketing the dietary supplement with the structure-function claim. Also, the notification must include the text of the claim, as well as other information, such as the name and address of the notifier. Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease.

FDA does not require conventional food manufacturers to notify FDA about their structure-function claims or to carry a disclaimer.

Misuse of FDA’s logo may violate federal law.

FDA’s logo is for official government use only. FDA’s logo should not be used to misrepresent the agency or to suggest that FDA endorses any private organization, product, or service.
These are just some of the many ways FDA is responsible for protecting the public health.

This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


SCV NewsBreak
Loading...
Related Content
LOCAL NEWS HEADLINES
Tuesday, Jul 25, 2017
DVC Merging Into Child & Family Center
The Child & Family Center and Domestic Violence Center of Santa Clarita Valley have announced their intention to join forces and merge into a single organization to better serve the needs of the growing Santa Clarita community.
Tuesday, Jul 25, 2017
Report of Bank Robbery at Logix Valencia; Deputies on Scene
Santa Clarita deputies are investigating a report of a bank robbery at the Logix location on McBean Parkway.
Tuesday, Jul 25, 2017
Officials Issue Travel Alert for LAX Commuters
Santa Clarita’s night-time commuters might notice some slowing on the freeway in the coming weeks, due to some road construction projects, officials said Tuesday.
Keep Up With Our Facebook

Latest Additions to SCVNews.com
For 42 years Soroptimist International of Valencia has been committed to the Live Your Dream program awarding cash grants to disadvantaged women.
Aug. 1: Summer “Wine” Down to Raise Funds for Disadvantaged Women
Tonight on SCV NewsBreak, A bear sighting was reported in Newhall Tuesday morning. Plus, the Child & Family Center and Domestic Violence Center of Santa Clarita Valley are going forces and planning to merge. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Tuesday, July 25, 2017
The California State University (CSU) has partnered with the Los Angeles Cleantech Incubator (LACI) to develop the next generation of clean energy entrepreneurs.
CSU Receives Grant; Will Fund Workshops for Clean Energy Entrepreneurs
The largest-ever concert series devoted entirely to the music of renowned composer John Luther Adams (Music BFA 73) takes place this week (July 26-July 30). Hosted by SFJAZZ, the festival takes place in several venues in San Francisco, including the Miner Auditorium, Grace Cathedral and the Sutro Baths at Lands End in the Golden Gate National Recreation Area.
Concert Series Devoted Entirely to CalARTS Alum
The Child & Family Center and Domestic Violence Center of Santa Clarita Valley have announced their intention to join forces and merge into a single organization to better serve the needs of the growing Santa Clarita community.
DVC Merging Into Child & Family Center
Local artist Chrystal Walker presents a one-woman show at FastFrame Valencia, located at 24204 Valencia Blvd., during September.
Sept. 1: One-Woman Show on Printmaking by Local Artist
Santa Clarita deputies are investigating a report of a bank robbery at the Logix location on McBean Parkway.
Report of Bank Robbery at Logix Valencia; Deputies on Scene
Santa Clarita’s night-time commuters might notice some slowing on the freeway in the coming weeks, due to some road construction projects, officials said Tuesday.
Officials Issue Travel Alert for LAX Commuters
Knowing that up to 70 percent of residential water is used for landscaping, it’s no surprise that conscientious homeowners are looking for efficient irrigation methods to minimize water waste, and lower household water bills.
Aug. 19: CSUN-al Offering Class on Water-Saving Methods for Home and Garden
CHP officers and Fish and Wildlife officials were unable to locate a bear reported near Calgrove Boulevard and Wiley Canyon Road, in Newhall on Tuesday morning.
Bear Sighting in Newhall
Despite robust closed escrow sales in June, California pending home sales slipped for the sixth consecutive month, suggesting an impending slowdown in the state's housing market as the peak homebuying season winds down, the CALIFORNIA ASSOCIATION OF REALTORS® (C.A.R.) said today.
State Sees Downward Trend in June Home Sales
On Saturday, August 19, 2017, test your strength, stamina, and endurance at the 12th Annual Plane Pull fundraiser at the Long Beach Airport.
Aug. 19: Annual Plane Pull Benefiting Local Non-Profit
Trey Killian tossed seven shutout innings to lead the Lancaster JetHawks to a 3-0 win over the Rancho Cucamonga Quakes on Monday night at LoanMart Field
Killian Gets 7th Win; Throws for Seven Shutout Innings
According to the South Coast Air Quality Management District, air quality will be unhealthy for sensitive individuals in Santa Clarita Valley Tuesday.
Air Quality Advisory for Sensitive Individuals in SCV
Rep. Steve Knight’s (CA-25) bill, H.R. 2333, Small Business Investment Opportunity (SBIO) Act of 2017, passed the House Monday with unanimous support.
Knight Bill to Improve Small Business Investments Unanimously Passes House
1915 - Pioneer Juan Batista Suraco buried in a family graveyard, currently unmarked, in Bouquet Canyon near Benz Road [story]
The Los Angeles Dodgers Monday reinstated left-handed pitcher Hyun-Jin Ryu from the 10-day disabled list, put Clayton Kershaw on the DL with low back strain, among other roster moves.
Dodgers Roster Moves: Kershaw & McCarthy on DL, Ryu Reinstated
Sierra Bancorp, parent of Bank of the Sierra, today announced its unaudited financial results for the three- and six-month periods ended June 30, 2017.
Sierra Bancorp Reports Earnings for First Half of 2017
Marston's restaurant in Valencia will donate 20 percent of patrons' bills for breakfast, lunch or dinner to the fundraising effort for the new Santa Clarita Valley Senior Center on Tuesday, July 25.
July 25: Dine at Marston’s, Benefit New SCV Senior Center
The county of Los Angeles seeks to block reopening of the Aliso Canyon natural gas storage field until an earthquake analysis is completed.
L.A. County Moves to Block Aliso Gas Field Reopening
Tonight on SCV NewsBreak, COC's MakerSpaces received a grant to enhance their centers on both campuses. Plus, the L.A. SummerFEST needs your help. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Monday, July 24, 2017
Here's a preview of Santa Clarita arts-related events for July 26-28, 2017.
July 26-28: Santa Clarita Arts Calendar
Alfredo Manzano is the new head coach of the Saugus boys basketball program, Saugus High School Principal Vince Ferry announced today.
Manzano Named New Saugus Boys Basketball Coach
College of the Canyons has been awarded a $311,432 grant to enhance its MakerSpace centers at both COC campuses with additional equipment, courses, training and internships.
COC ‘MakerSpace’ Centers Awarded $311,432 Grant
Organizers of the non-profit Santa Clarita Festival are seeking the community's help to cover a funding shortfall for the the ninth annual L.A. SummerFEST, a cultural festival featuring free performances of Shakespeare’s plays.
L.A. SummerFEST Seeks Donations to Keep Shakespeare Onstage
The city of Santa Clarita’s New Heights Artist Development Series offers free local workshops, panel discussions and lectures designed specifically with the creative individual in mind.
New Heights Artist Development Series Fosters Creative Growth
Wolf Creek Brewery will host a "Pints & Paws" fundraiser at Wolf Creek Brewery to benefit the SCV Education Foundation on Tuesday, July 25 starting at 4 p.m.
July 25: Pints & Paws Fundraiser for SCV Education Foundation
A GoFundMe crowdfunding page has been set up to help cover funeral expenses for a mother and two of her children killed in a rollover crash on Highway 14 in Acton Thursday.
Funeral Expenses Fund Set Up for 3 Dead in Acton Rollover Crash
Mylz Jones, Collin Ferguson and Yonathan Daza each delivered four hits to help lift the JetHawks over the Lake Elsinore Storm, 14-8, on Sunday evening at The Hangar.
JetHawks Power Through Storm 14-8 Sunday
The Lancaster JetHawks combined for 13 runs in the fourth and fifth innings and cruised to a 14-3 victory over the Lake Elsinore Storm on Saturday night at The Hangar.
Two Huge Innings Lift JetHawks to Blowout Win Saturday
Garrett Hampson delivered three hits and drove in four to lead the Lancaster JetHawks over the Lake Elsinore Storm, 10-7, on Friday night at The Hangar.
Hampson Helps ‘Hawks Weather Storm, Even Series Friday
Here is the Saugus (Zone 4) Public Safety and Crime Prevention Information for the week of 07/10/17 – 07/16/17:
Crime Blotter: Grand Theft Auto, Vehicle Burglary in Saugus
The Centers for Disease Control and Prevention has awarded more than $12 million to California and 22 more states plus the District of Columbia to support their responses to the opioid overdose epidemic.
CDC Awards $12 Million to California, 22 More States to Fight Opioid Epidemic
Here is the Stevenson Ranch: Zone 3 Public Safety and Crime Prevention Information for 07/03/17 through 07/16/17:
Crime Blotter: Petty Theft, Vehicle Burglary, Assault in Stevenson Ranch
The California Department of Water Resources is seeking validation of $11 billion in bonds to fund Gov. Jerry Brown’s Sacramento-San Joaquin Delta tunnel project, California Water Fix, which cleared its final environmental hurdle on Friday.
California Sues to Validate Bonds to Fund Delta Tunnels Project
The Castaic Lake Water Agency's Planning and Engineering Committee has scheduled a meeting for Tuesday, August 1 starting at 5:30 p.m.
August 1: CLWA Planning & Engineering Meeting