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FDA’s Team Tomato Fights Contamination

A fresh tomato is more than just a tasty addition to a sandwich or salad.

To scientists at the Food and Drug Administration (FDA), the tomato is an enigma and the focus of a group of researchers nicknamed "Team Tomato."

The mystery of the tomato has to do with its vulnerability to contamination by Salmonella, a bacterium that is a common cause of foodborne illness.

From 1973 to 2010, there were 15 multistate outbreaks of illnesses attributed to Salmonella contamination of raw tomatoes, with 12 of these outbreaks taking place since 2000. They resulted in almost 2,000 confirmed illnesses and three deaths, with states in the eastern U.S. hardest hit.

"The conditions in which tomatoes thrive are also the conditions in which Salmonella thrive," says Eric Brown, Ph.D., director of FDA’s Division of Microbiology. "But the tomato always presented an extra challenge because it is so short-lived. By the time it looked like contaminated tomatoes could be causing illnesses, the harvest would be gone."

So FDA’s focus has changed over the last decade to reducing contamination early in tomato production. Says Brown, "The question was clear: What can we do to intervene and prevent this contamination from happening in the first place?"

New Research

FDA microbiologist Rebecca Bell, Ph.D., lead researcher on the tomato team, says the agency studies tomatoes on an experimental farm at Virginia Tech’s Agriculture and Research Extension Center (AREC). This land is next to farms that have been the source of Salmonella contamination, giving the researchers access to real conditions and real threats.

The researchers collected more than a thousand bacteria in the soil and water in search of a natural enemy of Salmonella and they found one—a bacterium called Paenibacillus, which is benign to humans but kills Salmonella. FDA will be working with the Environmental Protection Agency (EPA) to facilitate the development of an organic treatment containing Paenibacillus that would kill Salmonella and other harmful organisms.

Bell says this will be a particularly valuable Salmonella-fighting tool in the mid-Atlantic region, where farmers often fumigate six inches down into the soil to kill harmful bacteria. Their methods for doing so may, ironically, create more opportunities for enteric pathogens (gastrointestinal organisms spread by contamination of food), such as Salmonella, to colonize in the roots of the tomato plants.

Published Studies

FDA researchers on this team follow parallel tracks towards the same goal of helping government and industry develop more effective and targeted agricultural practices that will improve the safety of fresh tomatoes.

Two examples of their work have been published this year in prominent professional journals.

  • In a study published in the Journal of Applied and Environmental Microbiology, microbiologist Jie Zheng, Ph.D., and other FDA researchers explain how they set out to better understand how fresh tomatoes become contaminated with Salmonella. The researchers found that quality of the water is a key factor. Tomatoes can become contaminated at specific times during the growing season, indicating the importance of using clean water to irrigate at planting or when applying pesticides.
  • In a study published in the journal BMC Microbiology, microbiologist Andrea Otteson, Ph.D., and FDA colleagues compared the tomato-growing environments of California, Virginia and Florida. The researchers are developing a baseline of microflora (including algae, fungi, and bacteria) associated with tomato crops at high or low risk of Salmonella contamination. The researchers are also considering other factors, such as the crops’ proximity to poultry farms—a potential source of Salmonella—or certain fungi in the soil. California has not had as many Salmonella outbreaks in tomatoes, and this research may be able to pinpoint the conditions on the East Coast that would be the safest for tomato crops, Otteson says.

The Practical Application

So what does FDA do with all this information?

The agency’s tomato research is shared on an ongoing basis with industry and agricultural extension systems at the state level. Steve Rideout, Ph.D., director of Virginia Tech’s AREC, says that he and his staff exchange research findings with FDA and share that information with growers.

"There are still a lot of unknowns when it comes to contamination of tomatoes," says Michael Mahovic, Ph.D., a consumer safety officer on FDA’s Produce Safety Staff. "But our research helps open a window."

Findings by FDA researchers were among the building blocks of the Proposed Produce Safety Rule mandated by the FDA Food Safety Modernization Act (FSMA), Mahovic says. The proposed rule would establish science-based standards for the production and harvesting of fruits and vegetables. FSMA gave FDA a mandate to implement a system that emphasizes prevention of risks to public health.

The tomato industry has worked closely with FDA in setting its own safety standards, says David Gombas, Ph.D., senior vice president of the United Fresh Produce Association. Industry-wide safety guidelines were adopted in 2008. And in 2009, the industry issued food safety and auditing standards, commonly called the Tomato Metrics, for growers, greenhouse operators, and packers.

Mahovic says FDA used these industry standards as the basis for its own draft guidance documents in 2009 that recommended ways in which microbial food safety hazards could be reduced throughout the tomato supply chain.

Gombas says the tomato industry continues to have a close working relationship with FDA, with frequent meetings and conversations about the latest research. The industry provides FDA access to farms and crops. "We’re all working together on this," he says.

Studying the Genes

There is another arm of this work for Team Tomato—researching the genes of the disease-causing bacteria. While the agency’s other research in field and lab focuses on preventing tomatoes from becoming contaminated, the goal of the gene research is to prevent illnesses once Salmonella is detected.

FDA wants faster ways to track down the source of an outbreak of foodborne illnesses, explains Captain Thomas Hill, MPH, U.S. Public Health Service, an environmental health specialist in FDA’s Coordinated Outbreak Response Network, who is also a member of Team Tomato. "I come at this from the outbreak perspective. Part of our mission is to prevent the next outbreak."

Bell explains that the agency has been developing bacterial genetic sequences (the ordered chemical building blocks of DNA). This work will be part of a public database of bacterial gene sequences that will allow scientists to rapidly identify disease-causing bacteria and locate their source. "There has been a big data gap in the past, and we’re looking to correct that," says Bell.

Sound Science

In addition to its focus on the prevention of foodborne illnesses, Team Tomato’s work advances another FDA priority: the use of sound science—in this case what we call regulatory science—to support the agency’s oversight of the nation’s food supply.

"Team Tomato is one of the best examples of regulatory science that we have to offer," says Brown. "The scientific information that Team Tomato has gleaned so far is helping to answer some very tough questions related to tomato safety and Salmonella in the farm environment."

Brown notes, "Considering the number of people who eat tomatoes, the rate of infection from Salmonella is very low. But it’s a very popular food, and we are determined to make that risk as low as possible."

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

July 8, 2013

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm359658.htm

Use Sunscreen Spray? Avoid Open Flame

You love a good summer barbecue and wisely use sunscreen if you are out in the sun. What you may not know is that if you apply certain sunscreen sprays and then come close to a source of flame, you may risk the sunscreen catching fire and giving you a serious burn.

The Food and Drug Administration (FDA) has become aware of five separate incidents in which people wearing sunscreen spray near sources of flame suffered significant burns that required medical treatment. The specific products reported to have been used in these cases were voluntarily recalled from the market, so should no longer be on store shelves.

However, many other sunscreen spray products contain flammable ingredients, commonly alcohol. The same is true for certain other spray products, such as hairspray and insect repellants, and even some non-spray sunscreens may contain flammable ingredients. Many flammable products have a label warning against their use near an open flame.

You should never apply a product labeled as flammable while you are near a source of flame. In the five incidents reported to FDA, however, the burns occurred after the sunscreen spray had been applied. The ignition sources were varied and involved lighting a cigarette, standing too close to a lit citronella candle, approaching a grill, and in one case, doing some welding. These incidents suggest that there is a possibility of catching fire if you are near an open flame or a spark after spraying on a flammable sunscreen—even if you believe you have waited a sufficient time for the sunscreen to dry and your skin feels dry.

"Based on this information, we recommend that after you have applied a sunscreen spray labeled as flammable, you consider avoiding being near an open flame, sparks or an ignition source," says Narayan Nair, M.D., a lead medical officer at FDA.

No children were involved in the reported burn incidents involving sunscreen sprays. However, keeping children safe near flammable materials is very important because burns have the potential to be more severe in children compared to adults. Parents and caregivers should read the product label and choose a sunscreen that is not flammable if there is a possibility that the child will be near a source of flame.

Sunscreen a Must

Lydia Velazquez, Pharm.D., an FDA expert on sunscreen and other skin-related products, says people should "absolutely be using a sunscreen product before venturing out in the summer sun." Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF (Sun Protection Factor) value of 15 or higher and other sun protection measures including: limiting time in the sun, especially from 10 a.m. to 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses.

"It’s always important to read the label of a product before you use it and to follow the directions," Velazquez says. Also consider your location and activities. Just as you should choose a water-resistant sunscreen if you will be swimming or sweating, if you anticipate being near an open flame or another source that may give off sparks, look closely for flammability warnings on your sunscreen product and consider using a non-flammable sunscreen instead.

Safety Precautions

To stay safe, do the following:

  • When you choose a sunscreen, think about where you’ll be using it. If you’ll be anywhere near a flame source, avoid any product with a flammability warning and choose another non-flammable sunscreen product instead. This recommendation is particularly important when it comes to choosing a product for children since they are frequently active and may get near a flame source.
  • While applying and wearing sunscreen products labeled as flammable, do not smoke, and avoid open flames from lighting cigarettes, lit cigarettes, grilling, candles or sparking materials.
  • Do not apply flammable products to yourself or someone else near an open flame.

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

July 3, 2013

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm359437.htm

FDA Forges Partnerships in Latin America

There’s a good chance that some staple in your daily life—a food that you like or a medical product that you need—comes from Latin America.

To ensure that these foods are safe and these medical products are safe and effective, the Food and Drug Administration (FDA) has staff who represent the agency in 44 countries and territories within Mexico, Central America, South America and the Caribbean.

And that staff brings multi-tasking to a whole new level.

Latin American companies that manufacture, grow or process products regulated by FDA must meet the same federal standards applied to their U.S. counterparts. By working with local government and industry, FDA’s Latin America Office (LAO) helps ensure that this critical safeguard is effective.

That’s no small task.

"If you think about the 44 countries and territories that typically contain a Ministry of Health and a Ministry of Agriculture, that’s 88 entities we have the opportunity to communicate with, sometimes on a daily basis," says Michael Rogers, LAO director. (Typically the Ministry of Health in each country covers medical products and processed foods, while the Ministry of Agriculture covers produce.)

Of all the products regulated by FDA, which include food, drugs, medical devices and others, about 30 percent come from the Latin American region. The percentage is even greater for fresh produce and seafood. Of the top 10 countries exporting fresh produce to the U.S., eight—Mexico, Guatemala, Chile, the Dominican Republic, Peru, Costa Rica, Honduras and Ecuador—are in Latin America.

LAO’s challenge is made more complex by the fact that Latin America is so diverse, home to a wide variety of languages, cultures and economic realities, as well as a range of regulatory and public health systems.

LAO’s Responsibilities

The LAO opened posts in San Jose, Costa Rica, and Santiago, Chile in 2009. A post in Mexico City opened in 2010. The post that focuses largely on Brazil operates from FDA headquarters in Silver Spring, Maryland. LAO’s responsibilities and strategic objectives include:

  • developing contacts to ensure that FDA’s counterparts in Latin America and stakeholders from industry, commerce, agriculture and academia are informed about FDA regulations and processes affecting them;
  • establishing effective communication—in languages that include Spanish, Portuguese and English—with FDA’s counterparts in each country;
  • working with headquarters in developing procedures for U.S. inspection of Latin American facilities involved in the production of FDA-regulated products, as well as working with local governments to join and follow up on FDA’s inspections when significant problems are observed;
  • assisting FDA efforts in emergencies, such as a serious and widespread problem with an FDA-regulated product; and
  • coordinating with headquarters in fostering mutually beneficial partnerships related to laboratory testing for food safety.

Opening Lines of Communication

"Part of what we do is to figure out who the most relevant, knowledgeable and influential people are, whether in government, industry, commerce, agriculture or academia," says Edmundo Garcia, assistant regional director in Chile. "We know these people. We know these agencies. And they know us."

According to Lisa Lopez, assistant regional director in Costa Rica, key to these efforts are FDA foreign-service national employees who come from the country in which they serve. They not only speak the language literally, but they know the nuances of their culture and government, Lopez says.

Rogers says the agency’s counterparts in Latin America benefit by understanding FDA’s approach to product safety and quality. "I have seen that public health protection is a common language and mission between regulators," he says.

"In some cases, we have seen host governments take FDA’s information about a noncompliant firm or product, and subsequently initiate their own action. These actions, taken under local law, not only maximize resources but far exceed what FDA can achieve on its own," Rogers says.

One thing that has helped enormously has been the establishment of a single e-mail address.

Poised to Respond

Staff members at each post collect information to better understand the laws and regulatory systems that exist within the 44 countries and territories. "In an emergency, such as a foodborne illness outbreak, we need to be well positioned and prepared to reach out to regulatory entities so they can help us understand the scope of the problem and what FDA’s role will be in helping to restore safety," Rogers says.

"Further, we work with headquarters to assess what impact the affected products might have on the U.S," he adds. Should import inspectors be alerted? Are these products already in the U.S.? Is a recall needed?

On the other hand, Rogers says it is important that Latin American countries are well informed about essential U.S. regulatory initiatives, such as the landmark FDA Food Safety Modernization Act (FSMA), designed to prevent food safety problems before they occur.

"I see FSMA as an enormous game changer in the global marketplace of which Latin America is a key player," he adds. LAO staff has met frequently with Latin American counterparts in agriculture, public health and commerce to relay information about FSMA’s role in ensuring that imported products are safe for U.S. consumers.

"I have a saying," Rogers says. "In some cases, what’s old news to us is new news to the people who don’t have routine contact with the FDA. And so we are serving as the face of the agency to carry forward these messages."

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

July 1, 2013

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm358870.htm

Stimuloid & Ejaculoid Review

By: Minotaur

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…