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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.
FDA encourages health care professionals and consumers to report problems with medical products, including
Report problems to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.
Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.
The anti-seizure medication Potiga (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. Pigment changes in the retina have the potential to cause serious eye disease with loss of vision.
Risk: It is not yet known whether the retinal pigment changes specifically caused by Potiga lead to visual impairment, although several patients have reported impaired vision. In cases reported, skin discoloration appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes. The discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients.
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Saratoga Therapeutics, LLC of North Wales, PA, recalled 900 bottles of ebA Multivitamin Supplement because they may contain milk components—milk proteins and lactose—not listed on the label. Instead, the label lists the product as being free of milk components.
Risk: People with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction. People who are lactose intolerant run the risk of gastrointestinal symptoms.
ebA Multivitamin Supplement was distributed nationwide and in Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland and Tasmania. It reached consumers by mail order, fax order, Internet sales and doctors’ office sales.
The vitamins are in a white plastic bottle with white, green and blue labeling. The expiration date is listed beneath the warning section on the label. Affected lot numbers include #0912164/expiration date 12/12 and #1110354/expiration date 10/14.
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At very high blood glucose levels (1024 mg/dL and above), the One Touch Verio IQ Blood Glucose Meter from LifeScan Inc. will turn off instead of displaying the message “Extreme High Glucose above 600 mg/dL,” as intended.
Risk: Because diagnosis and treatment of extreme hyperglycemia (too much sugar in the blood) may be delayed or incorrect treatment may be given, serious adverse health consequences, including death, may occur.
The over-the-counter device is intended for use by patients when outside the health care facility to monitor glucose levels of blood drawn from the fingertips. When turned back on, it enters the “set-up” mode, requiring the user to confirm the date and time settings before retesting. If the glucose level is still dangerously high, it will shut down again. The meters were distributed from December 14, 2011 through March 7, 2013.
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FDA received 458 reports of medical bed mattress covers that failed to prevent blood and body fluids from leaking into the mattress. This can occur if the mattress covers become worn or damaged from small holes or rips in the fabric from incorrect cleaning, disinfecting and laundering. Some reports say that if fluids penetrate the mattress, they can later leak out if another patient is placed upon it.
Risk: Patients are at risk for infection if they come into contact with blood and body fluids from other patients. In addition, wet and soiled mattresses can be a source of contamination during outbreaks of infection. FDA is concerned this problem may be under-recognized by health care providers, staff and caregivers. These reports came in from January 2011 to January 2013.
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Several manufacturers have recalled their products due to concerns associated with quality control processes that have been compromised and cannot ensure the products’ sterility.
Risk: Patients are at an increased risk of infection if a sterile medical product is compromised.
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In March 2013, FDA required safety labeling changes to be made to 53 drugs, including the antidepressant Wellbutrin (bupropion hydrochloride) and the nonsteroidal anti-inflammatory drug (NSAID) Anaprox (naproxen).
In general, changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.
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This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 21, 2013
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm353341.htm
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Although everyone is aware of skin cancer and the role of sunscreen in helping to prevent it, the details that will save lives are often surprising even to savvy consumers.
Did you know that some sunscreens protect against only the sun’s ultraviolet B (UVB) rays and not its ultraviolet A (UVA) rays, which also contribute to skin cancer? That no sunscreen completely blocks UV radiation, and that other protections are needed too? That no sunscreens are waterproof?
As summer approaches, the Food and Drug Administration (FDA) has taken steps on multiple fronts to protect consumers from the skin damage that can be caused by too much exposure to the sun.
This is the first summer in which FDA’s new rules governing sunscreen labeling are in effect. Using the latest available science, in 2011 the agency established testing and labeling requirements, which became final in December 2012.
One of the most important requirements: Testing and labeling that identifies sunscreens that are "broad spectrum," meaning they offer protection against both UVB and UVA rays. All sunscreen products offer protection against UVB rays, which are the primary cause of sunburn. But both UVB and UVA rays contribute to sun-induced skin cancer and premature skin aging.
"Based on scientific studies, we have determined that broad spectrum sunscreens with a Sun Protection Factor (SPF) of at least 15 can help reduce the risk of sun-induced skin cancer and premature skin aging when used with sun protective measures, as directed," said Reynold Tan, Ph.D., a scientist in FDA’s Division of Nonprescription Regulation Development. "We hope consumers use the information to make good choices."
Under final FDA regulations, products that pass a broad spectrum test can be labeled "broad spectrum" on the front of the product.
Sunscreens that are not broad spectrum or that lack an SPF of at least 15 must now carry a warning: "Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging."
And FDA’s regulations now require that if a product’s front label makes claims of being water resistant, it must designate whether it’s protective for 40 or for 80 minutes while swimming or sweating. Additionally, manufacturers may no longer make claims that their sunscreens are "waterproof" or "sweatproof."
Products may no longer be identified as "sunblocks" or claim instant protection or protection for more than two hours without reapplying.
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FDA is supporting "Don’t Fry Day." The awareness campaign is sponsored every year on the Friday before Memorial Day by the National Council on Skin Cancer Prevention. The Environmental Protection Agency (EPA) also supports the effort.
The message:
For more information on "Don’t Fry Day" and skin safety, visit: www.skincancerprevention.org.
FDA is considering whether additional changes are needed to sunscreen regulations, including requiring that sunscreens with an SPF value of more than 50 to be labeled simply "SPF 50+." FDA has no data demonstrating that sunscreens with an SPF of more than 50 provide additional benefits compared to those with SPF 50.
FDA has also requested additional data from manufacturers of sunscreen spray products to ensure their effectiveness and to determine whether they present a safety concern if inhaled unintentionally. In both cases, FDA is currently evaluating information received in response to public opportunities for comment.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 15, 2013
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm352255.htm
Foods from genetically engineered organisms, also known as biotech foods and referred to by some as food from genetically modified organisms (GMOs), have been in our food supply for about 20 years.
Genetic engineering refers to certain methods that scientists use to introduce new traits or characteristics to an organism. For example, plants may be genetically engineered to produce characteristics that enhance the growth or nutritional value of food crops.
Using a science-based approach, the Food and Drug Administration (FDA) regulates foods and ingredients made from genetically engineered plants to help ensure that they are safe to eat.
Since people have been modifying plants for thousands of years through breeding and selection, FDA uses the term "genetically engineered," or "GE," to distinguish plants that have been modified using modern biotechnology from those modified through traditional breeding.
FDA regulates food from GE crops in conjunction with the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). USDA’s Animal and Plant Health Inspection Service is responsible for protecting agriculture from pests and disease, including making sure that all new GE plant varieties pose no pest risk to other plants. EPA regulates pesticides, including those bioengineered into food crops, to make sure that pesticides are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment.
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The first genetically engineered microorganism was developed about 40 years ago; soon afterward the technology to genetically engineer plants and animals was developed. Food products made from GE microbial and plant sources have been in the food supply since the 1990s. The first food product from a GE microbe was an enzyme preparation used in the production of many cheeses.
Cotton, corn and soybeans are the most common GE crops in the U.S., according to USDA. In 2012, GE cotton accounted for 94 percent of all cotton planted, GE soybeans accounted for 93 percent of soybeans planted, and GE corn accounted for 88 percent of corn planted.
"Most GE crops are used as sources of food ingredients and as sources of animal feed," says Dennis Keefe, Ph.D., director of FDA’s Office of Food Additive Safety. Corn, soybean and cotton plants—genetically engineered to ward off pests or to tolerate herbicides—are used extensively to produce food ingredients such as corn starch (in soups and sauces), corn syrup (as a sweetener) and cottonseed and soybean oil (in mayonnaise, salad dressings, cereals, breads and snack foods).
There are also new varieties of several other foods, such as squash and papayas, which are from plants engineered to resist plant diseases.
"A few plants have been engineered for nutritional traits," says Keefe. In 2012, FDA evaluated a soybean with increased amounts of omega-3 fatty acid—a polyunsaturated fatty acid that is associated with a reduced risk of heart disease.
Food and food ingredients derived from GE plants must adhere to the same safety requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act that apply to food and food ingredients derived from traditionally bred plants.
FDA encourages developers of GE plants to consult with the agency before marketing their products. Although the consultation is voluntary, Keefe says developers find it helpful in determining the steps necessary to ensure that food products made from their plants are safe and otherwise lawful.
The developer produces a safety assessment, which includes the identification of distinguishing attributes of new genetic traits, whether any new material in food made from the GE plant could be toxic or allergenic when eaten, and a comparison of the levels of nutrients in the GE plant to traditionally bred plants.
FDA scientists evaluate the safety assessment and also review relevant data and information that are publicly available in published scientific literature and the agency’s own records.
The consultation is complete only when FDA’s team of scientists are satisfied with the developer’s safety assessment and have no further questions regarding safety or other regulatory issues.
As of May 2013, FDA has completed 96 consultations on genetically engineered crops. A complete list of all completed consultations and our responses are available at www.fda.gov/bioconinventory.
While FDA regulates foods and ingredients, including foods made from GE plants, the agency neither supports GE plants based on their perceived benefits nor opposes them based on their perceived risks. FDA’s priority is to ensure that all foods, including those derived from GE plants, are safe and otherwise in compliance with the FD&C Act and applicable regulations.
However, FDA recognizes that there are diverse views among food manufacturers, the agricultural industry and the public.
Many consumers are interested in knowing whether the food they serve their families is produced using genetic engineering. Food manufacturers may indicate through voluntary labeling whether foods have or have not been developed through genetic engineering, provided that such labeling is truthful and not misleading.
FDA supports such voluntary labeling and has issued draft guidance on this labeling to the food manufacturing industry.
Under the FD&C Act, food labeling that is false or misleading is generally prohibited. Food labeling is misleading if it fails to reveal "material" facts—information that is material in light of statements made or suggested on the label, or material with respect to consequences that may result from the use of the food.
The agency has received two citizen petitions regarding FDA’s regulation of GE foods. These petitions request that FDA change its position on the labeling of such foods. The agency is currently reviewing those petitions and considering the issues presented.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 14, 2013
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm352067.htm
Thanks to nick of perfect body,i was offered a bottle of each of this product to sample a few guys.
so far i and 2 other guys have tried it and these are our reviews on it,
now im going to keep the detail in very basic terms so no one gets offended as its not a product intended for muscle and strentgh,but i was actually proven wrong on this too so read on,
first will start off with my mate,he is 21 years old.
his first trial with the product was on wednesday,
» Read full review…
