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Actualmente la actualización de las etiquetas es voluntaria, ésto hasta el 26 Julio del 2018 ó 26 de Julio del 2019 para compañías con ventas menores a los 10 millones de dólares. Más Adelante la FDA planea emitir nuevas normativas determinativas con respecto a las ventas anuales de comida.

La calidad de los gráficos es mucho mejor (Ver 21 C.F.R. §§ 101,9 y 101.36), también la FDA incluye una maqueta de la Información Nutricional donde se representa el formato, grosor de las líneas, forma de la letra y las principales especificaciones que antes figuraban en el Apendice B de 21 C.F.R. Parte 101.

La FDA ha respondido muchas preguntas sin embargo informa que mas adelante elaborará otras guías para consultas.

The products containing meat, chicken or egg as a main ingredient do not need to comply with GMO labeling requirements.

The USDA Agricultural Marketing Service is required to set its regulations within of two years after promulgation of the legislation. USDA will be responsible for determining the origin of the bioengineering and establish the process for classifying the manufacturers such as either “manufacturers of small meals” or ”food manufacturers very small.” The latter would be exempt from GMO labeling.

USDA will need to provide disclosure options, such as a symbol or a QR code or a toll free number to put consumers on notice of GMO declaration.

Capote Law Firm is proud to announce our partner Lisa Capote has received a Martindale Hubbell AV Preeminent rating. Martindale Hubbell’s peer review rating is based on five key areas: legal knowledge, analytical capabilities, judgment, communication ability and legal experience. AV Preeminent is the highest rating available.

As of June 1, 2009, FDA no longer accepts FDA registrations for OTC drugs specifically, drug establishment registration and drug listing information in paper format unless FDA grants a waiver which must be accompanying with a reason as to why the company cannot conduct its FDA registration via the internet.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to obtain FDA registration. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drug products that are not properly listed as required are misbranded and may be subject to regulatory action.

Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must obtain FDA registration from their OTC drugs and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent prior to importation. Any OTC drugs that arrive to the US border without the necessary labeler codes, establishment registration or drug listings will not be permitted into the US.

The FDA relies on registration, listing, and U. S. agent information for administering many key programs, including postmarketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application.

The new FDA registration online system requires many preliminary steps to ensure that the submitting company knows how to work the system and in fact has the authority to file the submissions on behalf of the company. Many companies do not have their FDA registrations simply because the company’s individuals do not understand the online system. Arrastia, Capote & Phang conducts the entire process from start to finish with minimal work on their client’s part, ensuring labeler codes, establishment registrations and NDC numbers are issued.

How Does FDA Identify a High-Risk (HR) Facility?

The agency is utilizing a decision-making process based on the risk factors identified in section 421(a)(1) of the FD&C Act, which are:

1. The known safety risks of the food manufactured, processed, packed, or held at the facility;
2. The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards;
3. The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls;
4. Whether the food manufactured, processed, packed or held at the facility meets the criteria for priority under section 801(h)(1) of the FD&C Act, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.;
5. Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) (concerning imported food) or 806 (voluntary qualified importer program) of the FD&C Act, as appropriate;
6. Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

For the FY 2011-13 planning cycle for domestic facilities, the decision-making process is based primarily on the first two factors listed, as well as certain additional criteria identified as part of the sixth factor. There are not data available at this time to characterize the third factor for all industry types. It will be incorporated as the Preventive Controls regulation and the data collection develop. The fourth factor applies only to foreign facilities. While the fifth factor may apply to some domestic facilities, the relevant certification programs have not yet been established.

Two additional factors that have been identified pursuant to the sixth item are: establishment type / type of activity conducted at the facility (manufacturer/processor, repacker/packer, etc.) and years since last inspection.

The method utilized is through a software program that assesses the characteristics of each facility in the agency’s inventory. SAS® software provides data access, analysis, and reporting from the agency’s internal data systems. The current model is best depicted with a decision tree as shown in Diagram 1 resulting in facilities being categorized as HR or NHR.

Identification of HR facilities is based on the known safety risks of foods at the industry-wide level and compliance history, which is firm specific.

• The “known safety risks” of food are based on broad, industry-level food commodity categories, e.g., bakery, leafy vegetables, spices. If a facility manufactures food commodity categories associated with foodborne outbreaks AND class I recalls, then they are placed in the HR facility category. If a facility manufactures food commodities associated with foodborne outbreaks OR class I recalls and they have not been inspected within the previous five fiscal years, then they are placed in the HR facility category.
• The facility-specific factor of “compliance history” is based on inspection results for a facility from the previous five fiscal years. Facilities with a history of non-compliance with food safety requirements (a history of three or more VAI within the five year time period) and those with food safety violations of regulatory significance (one or more OAI in the five year time period) are placed in the HR facility category.

Under the proposed FDA law, FDA officials that have a reasonable belief that an article or any other food that may be affected in a similar manner will be permitted access to records to pertaining to these food products.

Under the current FDA law, an FDA official may request records of a specific food product where there is reason to believe it is adulterated. The new regulations will expand FDA’s powers to review records. As an example, an importer of papaya from Mexico will automatically be detained under an Import Alert currently in place. If in the same container a different fruit, say mangos, are being shipped there is the potential that FDA officials “reasonably believe” the mangos, simply for being shipped with the papayas, can be adulterated. At that point, FDA can request documentation from the importer or supplier to confirm the status and safety of the product. The FDA law requires that these documents must be made available as soon as possible, but not to exceed 24 hours from the time of receipt of the request.

Although the new FDA law is only a proposed law, there is a potential it will become regulation after the prescribed notice and comment period. Importers and suppliers, alike, need to be prepared to turn over any and all documentation related to their food products on a moment’s notice that establishes the safety of the product.

The new regulation will place responsibility and accountability for food safety on the importer bringing food products into this country.

Importers of food products will not be required to implement a foreign supplier verification program. The verification program will need to provide adequate assurance that the food products have been produced under risk-based preventive controls. Some importers may already have a verification program integrated into their food safety protocols, others may not. For those who do not have a verification program currently in place an FDA lawyer can assist with creating and implementing an adequate verification program. An adequate verification program needs to ensure that the importer’s suppliers have systems in place to produce and harvest safe food.

The new FDA law will also allow for voluntary participation of an expedited importation program. Those importers choosing to participate must accompany all food shipments with safety certifications. The safety certifications will be issued by third-party accredited companies, however to date, FDA has not accredited any third-party companies. These third-party accreditation companies will do a site inspection, at the expense of the supplier, and assuming the supplier has the proper protocols in place and follows those protocols the third-party certification company will issue a certification. Customs and Border Protection and FDA will expedite those importations that are accompanied with these certification.

The new FDA law is and will continue to change the landscape of the food supply and those obligations for importers and food producers/harvesters alike. Consultation with an FDA lawyer can help ensure that you are up to date on the latest regulations as well as implementing the new regulations as they come to fruition.

Don’t Give the Gift of Food Poisoning; Keep Things Clean

• Wash hands with warm water and soap for 20 seconds before and after handling any food.
• Wash food-contact surfaces (cutting boards, dishes, utensils, countertops) with hot, soapy water before and after preparing each food item.
• Rinse fruits and vegetables thoroughly under cool running water and use a produce brush to remove surface dirt.
• Do not rinse raw meat and poultry before cooking in order to avoid spreading bacteria to areas around the sink and countertops.

Separate to Avoid Cross-Contamination

• Whether shopping in the store, storing food in the refrigerator at home, or while preparing meals, keep raw eggs, meat, poultry, seafood, and their juices away from foods that won’t be cooked.
• Consider using one cutting board only for foods that will be cooked, such as raw meat, poultry, and seafood, and another one for those that will not be cooked, such as raw fruits and vegetables.
• Keep fruits and vegetables that will be eaten raw separate from other foods such as raw meat, poultry or seafood—and from kitchen utensils used for those products.
• Do not put cooked meat or other food that is ready to eat on an unwashed plate that has held any raw eggs, meat, poultry, seafood, or their juices.

Cook to A Safe Internal Temperature

• Use a food thermometer to make sure meat, poultry, and fish are cooked to a safe internal temperature. To check a turkey for safety, insert a food thermometer into the innermost part of the thigh and wing and the thickest part of the breast. The turkey is safe when the temperature reaches 165ºF. If the turkey is stuffed, the temperature of the stuffing should also be 165ºF.
• Bring sauces, soups, and gravies to a rolling boil when reheating.
• Cook eggs until the yolk and white are firm. When making your own eggnog or other recipe calling for raw eggs, use pasteurized shell eggs, liquid or frozen pasteurized egg products, or powdered egg whites.
• Don’t eat uncooked cookie dough, which may contain raw eggs.

Chill Because Harmful Bacteria Grow Rapidly at Room Temperature

• Refrigerate leftovers and takeout foods—and any type of food that should be refrigerated, including pie—within two hours.
• Set your refrigerator at or below 40ºF and the freezer at 0ºF. Check both periodically with an appliance thermometer.
• Thaw safely in the refrigerator, under cold running water, or in the microwave—never at room temperature. Cook food that has been thawed in cold water or in the microwave immediately.
• Allow enough time to properly thaw food. For example, a 20-pound turkey needs four to five days to thaw completely in the refrigerator.
• Don’t taste food that looks or smells questionable. When in doubt, throw it out.
• Leftovers should be used within three to four days, unless frozen.

You’ve seen the turkey fryers and giant jugs of peanut oil. But you’re a little nervous. That’s a lot of hot oil! USDA’s Food Safety & Inspection Service has these tips to help you safely prepare a deep fat fried turkey.

Planning: Tips for Purchasing a Turkey

Before you purchase your turkey, check the instructions for your turkey fryer. Most fryers will accommodate a 12-16 lb. turkey. A larger turkey will not fit in the fryer and will take too long to cook. Don’t stuff a turkey that you’re going to fry!
Before you unwrap the turkey, take a minute to determine the amount of oil needed. Place the turkey in the fryer and add enough water to cover it. Do not fill the pot more than ¾ full; the oil level should be three inches to five inches from the top of the fryer. The turkey should be covered by about one to two inches. Remove the turkey and measure the amount of water – that’s how much oil you’ll need. Drain or pour out the water and dry the pot thoroughly.

Preparation: Check Your Food Safety Steps

Now for the turkey. As with all food preparation, remember to check your steps (clean, separate, cook and chill). As you prepare the bird, separate the raw turkey from fresh foods on your menu, and use separate cutting boards, plates, and utensils to avoid cross contamination.

If your turkey is frozen, make sure to thaw it before frying. You can thaw it in the refrigerator. It takes about 24 hours for every four to five pounds. Keep it refrigerated until about 30 minutes before cooking.

If you choose to marinade or to inject a flavor into the turkey, allow it to stand in the refrigerator for 24 to 48 hours before cooking. And always keep hands, utensils, and surfaces clean.

Cooking: Caution! Hot Oil!

Deep fat frying a turkey must be done OUTSIDE! Select a safe, flat outdoor location that is well-lit, well-ventilated and away from trees, shrubbery and buildings.

Heat the cooking oil to 350°F. Before lowering the turkey into the oil, turn the burner off. Do not just dunk the turkey in the oil. To avoid the oil bubbling over, gradually lower the turkey into the hot oil, pull it back out, and repeat until it is fully immersed. Turn the burner back on and bring the oil back to 350°F.

Monitor the temperature of the oil with a thermometer constantly during cooking. Never leave the hot oil unattended! Allow about three to five minutes per pound cooking time.

When the time is up, turn the burner off, and slowly lift the turkey out of the oil. Hold it over the fryer so the oil can drain. Check the temperature of the turkey with a food thermometer. The turkey is safely cooked when the food thermometer reaches a minimum internal temperature of 165°F in the innermost part of the thigh and wing and the thickest part of the breast.

Enjoy Your Meal

Cover the bird with foil and let it rest about 20 minutes before carving. After serving, refrigerate the leftovers within two hours in shallow containers. Refrigerate and use turkey leftovers for three to four days or freeze for three to four months.

Don’t forget about the oil! Once the turkey is out, remove the pot from the burner and move to a flat, safe place and allow the oil to cool, covered, overnight. Once the oil has cooled you can strain out the solids and use it again. Store in a cool, dry place for up to six months.