Monday, 15 January 2018

22 Ways to Lose 2 Inches of Belly Fat in 2 Weeks
A slimmer waist, healthier body, and reduced risk of chronic disease start today with these belly fat-fighting tips.

Let’s face it: that marshmallowy middle you’re sporting didn’t get there overnight. Stressful days at the office, indulging in one-too-many cheat meals, or finding excuses to skip a day, week, or month’s worth of workouts are all making it easy to pack on the pounds and making it difficult to get them off.

Watching that extra junk around your trunk turn your body into a full-blown Buddha belly puts you at an increased risk for heart disease, diabetes, and early death. Luckily, losing the weight doesn’t have to take forever; with these 22 belly fat-fighting tips, you can shave two inches off your waistline in as little as two weeks. Think your age will stand in the way of your weight loss? The 20 Ways to Lose Your Belly When You’re Older will help folks of any age get on track to their best body ever.

1.Start Your Day Early

Don’t let extra hours lounging in bed stand between you and a flatter belly. While getting enough sleep can help boost your metabolic rate, sleeping in may undo any benefit you’d enjoy from catching a few extra winks. One study reveals that late sleepers who snoozed past 10:45 in the morning ate nearly 250 more calories over the course of the day, despite eating half as many fruits and vegetables as their early bird counterparts. Even worse, they chowed down on more salty, sugary, and trans fat-laden fast food than those who woke up earlier. If you happen to head out of the house early, you’re in for an additional metabolic boost; researchers at Northwestern University have found that people exposed to just a short period of early morning sunlight had lower BMIs than their late-waking counterparts.

2.Bring on the Berries

Instead of satisfying your sweet tooth with some refined sugar, turn to berries and enjoy a slimmer waistline in no time. Berries are loaded with antioxidants, which can help reduce inflammation throughout the body, and research from the University of Michigan reveals that rats given a berry-rich diet shaved off a significant proportion of their belly fat when compared to a control group. Berries like strawberries, raspberries, blueberries, and blackberries are also loaded with resveratrol, an antioxidant pigment that has been linked to reductions in belly fat and a reduced risk of dementia, to boot.

3.Skip the Hydrogenated Oils

Those trans fats on your menu are hiding out in plain sight and sabotaging your lean belly plans every time you eat them. If a food product says it contains partially hydrogenated oils, you’re eating trans fat, which can increase your risk of heart disease, high cholesterol, and obesity with every bite. In fact, research conducted at Wake Forest University reveals that monkeys whose diets contained eight percent trans fat upped their body fat by 7.2 percent over a six-year study, while those who ate monounsaturated fat gained just a fraction of that amount. Instead of letting harmful trans fat take up space on your menu, fill up with the 20 Healthy Fats to Make You Thin.

4.Switch to Sprouted Bread

While it’s often assumed that bread is off-limits when you’re trying to lose belly fat, the right bread may actually expedite the process. Switching to sprouted bread can help out carb-lovers eager to get their fix without going up a belt size, thanks to the inulin content of sprouted grains. The results of a study published in Nutrition & Metabolism reveal that found that pre-diabetic study subjects whose diets were supplemented with inulin shaved off more belly fat and total weight than those whose meal plans didn’t pack this healthy prebiotic fiber.

5.Lift

Do you even lift, bro? If you’re serious about getting rid of that belly fat fast, resistance training might just be the key. A study from the Harvard School of Public Health found that adding weight training to adult male test subjects’ workouts significantly reduced their risk of abdominal obesity over a multi-year study period, although doing the same amount of cardio had no such effect. Research from the University of Maryland even found that just 16 weeks of weight training boosted study participants’ metabolic rates by a whopping 7.7 percent, making it easier to ditch those extra inches around your middle.

6.Say So Long to Sweeteners
While many people turn to artificial sweeteners in a misguided attempt to whittle their waistlines, those fake sugars are likely to have the opposite effect. According to researchers at Yale, artificial sweeteners are actually linked with an increased risk of abdominal obesity and weight gain, possibly because they can trigger cravings for the real stuff and spike insulin levels in a similar fashion to real sugar.
7.Make Fiber Your Friend
The secret to a slimmer stomach in no time? A whole lot of fiber in your diet. Although many people are loath to add carbs to their diet when they’re trying to lose weight, adding the right, fiber-rich ones can have inches off your belly in a hurry. In fact, researchers at Wake Forest Baptist Medical Center found that every 10-gram daily increase in soluble fiber was associated with a 3.7 percent decrease in dangerous visceral fat over five years. Those who were active got even leaner, shaving off twice that much fat in the same amount of time. To start ditching that extra belly fat today, add the 30 Best Foods For Fiber to your menu!
8.Swap Out Ketchup For Salsa

Sure, ketchup is tasty, but it’s also a serious saboteur when it comes your weight loss efforts. Ketchup is loaded with sugar — up to four grams per tablespoon — and bears little nutritional resemblance to the fruit from which it’s derived. Luckily, swapping out your ketchup for salsa can help you shave off that belly fat fast. Fresh tomatoes, like those used in salsa, are loaded with lycopene, which a study conducted at China Medical University in Taiwan links to reductions in both overall fat and waist circumference. If you like your salsa spicy, all the better; the capsaicin in hot peppers, like jalapeños and chipotles, can boost your metabolism, too.

9.Score Some Rays

While few would suggest you start hitting up the tanning beds for better health, getting some natural sunlight can help you get rid of those extra inches on your waist in a hurry.

Researchers at the Fred Hutchinson Cancer Research Center found that vitamin D-deficient overweight women between 50 and 75 who upped their intake of the so-called sunshine vitamin shed more weight and body fat than those who didn’t. To practice safe sun, make sure you’re limiting yourself to 15 sunscreen-free minutes per day.

10.Nosh on Some Nuts

Sometimes, to whip your body into shape, you have to get a little nutty. While nuts are high in fat, it’s that very fat that makes them such powerful weapons in the war against a ballooning belly. In fact, research from Reina Sofia University Hospital reveals that study participants who consumed a diet rich in monounsaturated fats, like those in nuts, over a 28-day period gained less belly fat than their saturated fat-consuming counterparts while improving their insulin sensitivity.

11.Think Fast

Instead of subjecting yourself to another endless workout, crank up the intensity and you’ll see results faster than you ever thought possible. The results of a study conducted at McMaster University in Ontario reveal that adult male study subjects who exercised intensely for a single minute had equivalent respiratory and metabolic changes to those who worked out at a slower pace for close to an hour, so if you want to burn through that belly fat, say so long to slow and steady.

12.Flavor Your Food With Garlic

A little garlic in your meals could mean a lot less weight around your middle. The results of a Korean study found that mice given a high-fat diet supplemented with garlic lost significantly more weight and abdominal fat than those who just ate fatty foods. Even better, they also improved their liver health, making it easier to stay healthy and burn off that excess fat in the long term. For more flavorful ways to make your food more enjoyable, turn to the 20 Spicy Recipes That Fire Up Your Metabolism and watch those pounds melt away.

13.Brush Up

Keeping a toothbrush handy can do more than polish up that smile (and counter the effects of all that belly-slimming garlic); brushing your teeth throughout the day can also help you ditch that belly fat fast. A study conducted a sample of over 14,000 participants found that brushing after every meal was linked to lower weight. That minty toothpaste flavor not only clashes with virtually every food, brushing may also trigger a Pavlovian response that tells your brain the kitchen’s closed.

14.Fill Up on Fish

If you’ve got weight to lose and you want it gone fast, try swapping out your usual proteins in favor of fish. Not only is fish lower in calories than an equivalent amount of beef or chicken, a study published in Obesity reveals study subjects who added omega-3 fatty acids, like those found in fish, to their diets shed more weight and had an easier time keeping it off than those who skipped them.

15.Don’t Give Up on Grains

You don’t have to go low-carb to ditch those extra pounds around your waist in a short period of time. In fact, opting for more whole grains might just get you there faster. Researchers at Tufts University have linked eating three or more daily servings of whole grains to as much as a 10 percent reduction in visceral body fat, the kind that ups your risk for chronic diseases, like diabetes, heart disease, and high blood pressure.

16.Add Some Acid

Don’t buy your tickets to Bonnaroo just yet; the kind of acid that will help you slim down is the stuff right inside your cabinet. A 12-week study published in Bioscience, Biotechnology, and Biochemistry reveals that obese study subjects who made vinegar part of their diet dropped more belly fat than a control group, and other research suggests that acidic foods, like vinegar, can increase the human carbohydrate metabolism by as much as 40 percent.

17.Snack on Some Veggies

Your parents weren’t kidding about how important veggies are for a healthy body. What they probably didn’t tell you, however, was that snacking on veggies is also one of the easiest ways to shed unwanted belly fat, too. According to a study published in the Journal of the Academy of Nutrition and Dietetics, opting for non-starchy veggies, like cauliflower, broccoli, and cucumber, as snacks helped overweight kids shed 17 percent of their visceral fat while improving their insulin sensitivity over a five-year period. Think snacking on veggies will leave you hungry? The 20 Most Filling Fruits and Veggies will have your belly satisfied in no time.
18.Crank Up the Calcium
Say cheese! Adding some extra calcium to your diet could be the key to getting that flat stomach you’ve been dreaming about. Over just 12 months, researchers at the University of Tennessee, Knoxville found that obese female study subjects who upped their calcium intake shed 11 pounds of body fat without other major dietary modifications. To keep your calcium choices healthy, try mixing it up between dairy sources, calcium-rich leafy greens, fatty fish, nuts, and seeds.
19.Snack on Some Tart Cherries
That sour cherry is pretty sweet when it comes to your health. The results of a study conducted at the University of Michigan found that rats given high-fat foods along with tart cherries ditched nine percent more body fat than those in a control group over just 12 weeks. Cherries are also a good source of antioxidant pigment resveratrol, which has been linked to reductions in belly fat, dementia risk, and lower rates of macular degeneration among the elderly.
20.Hit the Track
You don’t have to be the next Usain Bolt in the making to enjoy some serious belly-slimming results from hitting the track from time to time. Even a moderate-rate jog a few times a week can blast through that belly fat; in fact, a study conducted at Duke University Medical Center found that, over the course of an eight-month study, overweight adult study subjects who jogged 12 miles a week lost the most belly fat and burned 67 percent more calories than participants who did an equivalent amount of resistance exercise, or a combination of cardio and resistance work.
21.Sleep It Off
Want to lose that belly fat? In your dreams! Seriously, though: a good night’s sleep is one of the best ways to get rid of that extra fat around your waist for good. Among the 60,000 women participating in the Nurses’ Health Study, those who snoozed for fewer than five hours a night were at the greatest risk of becoming obese and gaining 30 or more pounds over the course of the 16-year study period when compared to those who slept for seven or more hours.
22.Close Up Shop

Stop treating your kitchen like an all-night diner and you’ll stop seeing those unwanted pounds piling onto your frame, too. The results of a study published in Cell Metabolism found that mice who only had access to food during an eight-hour period stayed slim over the course of the study, while those who ate the same number of calories over a 16-hour period gained significantly more weight, particularly around their middle. When you’re finished with dinner at night, shut the fridge and don’t look back until morning — your belly will thank you. When you do head back to the kitchen in the A.M., make sure the 40 Things Healthy Cooks Always Have in Their Kitchen are there waiting for you.

Saturday, 6 January 2018

DELICIOUS RECIPES

BUFFALO-ONION RANCH DIP
    INGREDIENTS
2 cups cut-up cooked chicken 1/4 cup cayenne pepper sauce 1 package (8 oz.) lowfat cream cheese, softened
Cook
2 MINS   COOK
Makes   1/2 cup buttermilk 1 package Knorr® French Onion recipe mix
3 CUPS
Prep
5 MINS
LET'S GET COOKING
1
Toss chicken with cayenne pepper sauce in microwave safe bowl. Stir in remaining ingredients.
2

Microwave until heated through, about 2 minutes, stirring once halfway through. Serve, if desired, with celery and your favorite dippers. Garnish, if desired, with crumbled blue cheese.

Wednesday, 3 January 2018

How to Lose Weight Quickly and Safely
You want to drop pounds, now. And you want to do it safely. But how?
First, keep in mind that many experts say it’s best to lose weight gradually. It’s more likely to stay off. If you shed pounds too fast, you’ll lose muscle, bone, and water instead of fat, says the Academy of Nutrition and Dietetics.
The academy’s advice: Aim to lose 1-2 pounds per week, and avoid fad diets or products that make promises that sound too good to be true. It’s best to base your weight loss on changes you can stick with over time.
For faster results, you’ll need to work with a doctor, to make sure that you stay healthy and get the nutrients that you need.
Make a Plan
You’ve probably heard the saying, “calories in, calories out”; as in, you just need to burn more calories than you eat and drink.
But it’s not that simple, as many people can tell you from their own experience.
Your metabolism -- how well your body turns calories into fuel -- also matters. And if you cut too many calories, it’s bad for you. You slow down your metabolism, and that can make you fall short on some nutrients.
There are many ways you can do this, without cutting calories too much. You could:
Cut back on portions.
Figure out how many calories you get in a usual day, and trim back a bit.
Read food labels to know how many calories are in each serving.
Drink more water, so you’re not so hungry.
Whatever method you use, you’ll need to favor good-for-you foods like vegetables, fruits, whole grains, and lean protein so you keep up good nutrition. Working with a dietitian is a good idea, so you make a plan that covers those needs.
Get Accountability and Support
Many apps can help you track your eating. Since you probably have your smartphone with you all the time, you can use it to keep up with your plan. Or keep a pen-and-paper food journal of what you ate and when.
You’ll also want to have people on your side to help you stay motivated and to cheer you on. So ask your family and friends to support your efforts to lose weight.
You might also want to join a weight loss group where you can talk about how it’s going with people who can relate. Or talk with someone you know who’s lost weight in a healthy way. Their encouragement is “contagious,” in a good way!
Find Out What Drives You to Eat
At the most basic level, food is fuel. It gives you energy to do things. But very few people eat just for that reason. It’s at every social gathering. And it’s where a lot of us turn when we have a rough day.
You’ll need to know what makes you want to eat when you’re not hungry, and have a plan for those moments.
The first step is finding out what your triggers are. Is it stress, anger, anxiety, or depression in a certain part of your life? Or is food your main reward when something good happens?
Next, try to notice when those feelings come up, and have a plan ready to do something else instead of eating. Could you take a walk? Text a friend?
Lastly, reward yourself for making a different choice. Just don’t use food as the reward.
Reset What and When You Eat
You don’t have to go vegan, gluten-free, or quit any particular food group to lose weight. In fact, you’re more likely to keep the pounds off for good if it’s something you can live with for the long term.
But it does make sense to cut way down on, or totally cut out, empty calories.
Limit added sugars. These are the sugars in cookies, cakes, sugar-sweetened drinks, and other items -- not the sugars that are naturally in fruits, for instance. Sugary foods often have a lot of calories but few nutrients. Aim to spend less than 10% of your daily calories on added sugars.

Weight Loss & Obesity

Weight Loss & Obesity Overview

Being obese means having so much body fat that your health is in danger. Having too much body fat can lead to type 2 diabetes, heart disease, high blood pressure, arthritis, sleep apnea, and stroke.

What Is Obesity?

If doctors tell you you're obese, they're not trying to make you feel bad. They're using a specific medical term -- obesity -- to talk with you about your weight.

The word "obesity" means too much body fat. It's usually based on your body mass index (BMI), which you can check using a BMI calculator. BMI compares your weight to your height.

If your BMI is 25 to 29.9, you're overweight but not obese. A BMI of 30 or more is in the obese range.

Small Changes Can Help

The good news is that you can take steps to lose weight. And losing even some weight can make a big difference to your health and how you feel. You may not have to lose as much as you might think in order to start seeing health benefits.

As a start, aim to lose 1-2 pounds a week. Adults who are overweight or obese should try to lose 5% to 10% of their current weight over 6 months, according to the National Heart, Lung, and Blood Institute.

If you're ready to get started with a weight loss program, ask your doctor to help you set personal goals and refer you to other professionals who can give you tips and help you reach your goals. For example, a nutritionist can help you with a food plan, and a physical therapist or trainer can help you move more.

You’ll want to go for steady progress over time, and to make lifestyle changes that work for you for the long run. That way you can start losing weight and feel better.

WHAT IS FAST FIT BODY SCULPTING?
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Fast Fit uses modern light technology to spot reduce troubled areas like the stomach, hips, thighs, and arms. This process may shrink fat cells resulting in inch and fat loss and is proven to reduce the appearance of cellulite. The light also stimulates fibroblasts, strengthening the collagen and elastin fibers to tone and tighten your skin. Your skin may see some improvements as well!
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It’s ok to be skeptical! Come meet the staff, and let us meet you! First, our trained staff will show you our wall of client success stories, then, we’ll do a body composition analysis. It’s very detailed and will show valuable information like your body fat percentage, muscle mass, visceral fat and your metabolic age. If time permits, you may also do a mini-trial session. It’s just a few minutes under the LED technology, but you can experience what it’s like, and see that’s it’s pain-free and very relaxing! You will then meet with the Lipolysis Consultant who will answer all your questions. Many clients can start their first session the same day! What are you waiting for? Client results vary.

Health Benefits of Zinc
Healthy Immune Function - Even mild to moderate zinc deficiency can depress the immune system through impaired macrophage and neutrophil functions,and associated effects.3 Zinc is also essential for creation and activation of T-lymphocytes.4,5 Further, low levels of zinchave been associated with increased susceptibility to pneumonia and other infections in children and the elderly.6-9
Alleviation of the Common Cold (*Controversial) - There are conflicting studies as to weather or not zinc supplements canalleviate symptoms of the common cold and shorten its duration. At least one study confirms decreased duration of cold symptoms comparedto a control,10 however, other studies report no effect.11,12 Since no harm is reported, increasing zinc intake could only help.
Healing of Cuts and Wounds - Zinc is essential for healthy skin and maintenance of mucosal membranes. Adequate levels of zincis necessary for proper wound healing.13
Reduced Severity and Duration of Diarrhea - Studies show that increased intake of zinc can reduce duration and severity ofdiarrhea in undernourished children with infections.14-17
Prevention and Reduction of Age-Related Eye Damage - High dietary intake of zinc, as well as vitamins C, E, and beta-carotene, has been associated with reduced age-related macular deneration in the edlerly.18
High Risk Groups for a Zinc Deficiency
Alcoholics - 30-50% of alcoholics have low levels of zinc because alcohol decreaseszinc absorption and increases urinary secretion of zinc.
Vegetarians - The bio-availability of zinc is higher in meats and thus moreeasily absorbed. Further legumes and whole grains contain phylates which bindzinc and inhibit absorption. Vegetarians should aim to eat 50% DV more zinc each day to ensure proper levels.(See lists of fruits and vegetables high in zinc.)
Pregnant and Lactating Women - A developing fetus requires a high amount of zinc,likewise, there is a high amount of zinc lost through breast milk after birth.
Older Infants who are Exclusively Breastfed - Infants older than 6 months shouldeat age-appropriate foods which provide zinc as the amount in breast milk is nolonger ample.
People with Sickle Cell Disease - For unknown reasons 44% of children, and 60-70%of adults with sickle cell disease have low levels of zinc.
People with Gastrointestinal and Other Diseases -Gastrointestinal surgery, Crohn's disease, ulcerative colitis, short bowel syndrome,and other digestive diseases can all decrease zinc absorption and increase zincloss from the body.
People consuming high doses of Iron Supplements - Iron can interfere with zinc absorption, to reduce this effect, ironsuppliments should be taken between meals to allow time for zinc to be absorbed properly.
People taking Diuretics - Thiazide diuretics such as chlorthalidone (Hygroton) and hydrochlorothiazide (Esidrix and HydroDIURIL)can increase zinc excretion by 60%, and over the long term, deplete body tissues of zinc stores. Be sure to consult your doctor or clinician to monitor your zinc level if you are taking these diuretics for a sustained period of time, and be sure to eat more zinc rich foods.

The 10 Best Foods High in Zinc + Printable One Page Sheet
Zinc is an essential mineral required by the body for maintaining a sense of smell, keeping a healthy immune system, building proteins, triggering enzymes, and creating DNA. Zinc also helps the cells in your body communicate by functioning as a neurotransmitter. A deficiency in zinc can lead to stunted growth, diarrhea, impotence, hair loss, eye and skin lesions, impaired appetite, and depressed immunity. Conversely, consuming too much zinc can lead to nausea, vomiting, loss of appetite, abdominal cramps, diarrhea, and headaches in the short term, and can disrupt absorption of copper and iron in the long term. If you have a zinc deficiency, then animal foods are better sources of zinc than plant foods.
Foods high in zinc include oysters, beef, lamb, toasted wheat germ, spinach, pumpkin seeds, squash seeds, nuts, dark chocolate, pork, chicken, beans, and mushrooms. The current daily value (DV) for Zinc is 15mg.
Below is a list of the top ten foods highest in zinc by common serving size, for more, see the list of high zinc foods by nutrient density, and the extended list of zinc rich foods.
Top 10 High Zinc Foods
#1: Seafood (Cooked Oysters)
Zinc in 100g Per 3oz (85g) Per 6 Oysters (42g)
78.6mg (524% DV) 66.8mg (445% DV) 33.0mg (220% DV)
Other Seafood High in Zinc (%DV per 3oz cooked): Crab (43%), and Lobster (41%).
#2: Beef and Lamb (Cooked Lean Beef Shortribs)
Zinc in 100g 1 Rack of Ribs (315g) 1 Lean Ribeye Fillet (129g)
12.3mg (82% DV) 38.7mg (258% DV) 14.2mg (95% DV)
Lamb is also a good source of Zinc (%DV per 3oz cooked): Lean Foreshank (49%), Lean Shoulder (46%) and Lean Cubed Lamb for Stewing (37%).
#3: Wheat Germ (Toasted)
Zinc in 100g Per Cup (113g) Per Ounce (28g)
16.7mg (111% DV) 18.8mg (126% DV) 4.7mg (31% DV)
Crude or Untoasted Wheat Germ is also a good source of Zinc providing 94% DV per cup.
#4: Spinach
Zinc in 100g (Cooked) Per Cup (Cooked - 180g) 100g (Raw)
0.8mg (5% DV) 1.4mg (9% DV) 0.5mg (4% DV)
Other Green Leafy Vegetables High in Zinc (%DV per cup): Amaranth Leaves, cooked (8%), and Endive and Radiccio, raw (2%).
#5: Pumpkin and Squash Seeds
Zinc in 100g Per Cup (64g) Per Ounce (28g)
10.3mg (69% DV) 6.6mg (44% DV) 2.9mg (19% DV)
Other Seeds High in Zinc (%DV per ounce): Sesame Seeds (19%), Sunflower (10%), Chia (9%), and Flaxseeds (8%). While phytates in seeds lower zinc absorption, they are still considered a good source of zinc.
#6: Nuts (Cashews)
Zinc in 100g (Roasted) Per Cup (137g) Per Ounce (28g)
5.6mg (37% DV) 7.7mg (51% DV) 1.6mg (10% DV)
Other Nuts High in Zinc (%DV per ounce): Pine nuts (12%), Pecans (9%), Almonds (6%), Walnuts (6%), Peanuts (6%), and Hazelnuts (5%).
#7: Cocoa and Chocolate (Cocoa Powder)
Zinc in 100g Per Cup (86g) Per Tablespoon (5g)
6.8mg (45% DV) 5.9mg (39% DV) 0.3mg (2% DV)
Dark baking Chocolate is also high in Zinc providing 85% DV per cup grated and 19% DV per 29g square.
Top 5 Benefits of Dark Chocolate.
#8: Pork & Chicken (Cooked Lean Pork Shoulder)
Zinc in 100g Per Steak (147g) Per 3oz (85g)
5.0mg (33% DV) 7.4mg (49% DV) 4.3mg (28% DV)
Chicken is also High in Zinc providing 15% DV per cooked drumstick.
#9: Beans (Cooked Chickpeas)
Zinc in 100g Per Cup (164g) Per 3oz (85g)
1.5mg (10% DV) 2.5mg (17% DV) 1.3mg (9% DV)
Other Beans High in Zinc (%DV per cup cooked): Baked Beans (39%), Adzuki (27%), and Kidney Beans (12%).
#10: Mushrooms (Cooked White Mushrooms)
Zinc in 100g Per Cup Pieces (156g) Per Mushroom (12g)
0.9mg (6% DV) 1.4mg (9% DV) 0.1mg (1% DV)
Other Mushrooms High in Zinc (%DV per Cup Pieces): Morel, raw (9%), Brown, raw and Portabella, grilled (5%), Oyster, raw (4%), and White, raw (2%). Four Dried Shitake mushrooms contain 8% DV and 4 raw shitake contain 4% DV.

Tuesday, 2 January 2018

FDA REQUIRES RESPONSES TO INSPECTION REQUESTS WITHIN 24 HOURS, ACCORDING TO NEW INSPECTION REFUSAL GUIDANCE
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance that outlines their interpretation of the term “refusal of inspection.” According to the guidance, FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 24 hours. Failure to confirm within 24 hours may be deemed refusal of inspection, resulting in refusal of that facility’s future food shipments to the US. Further, any attempts to limit or condition the inspection in any way likewise may be deemed a refusal of inspection, with the same harsh consequences.
What are the Consequences of Being Deemed a Refusal?
Facilities that refuse inspection are placed under Import Alert 99-32, and their food articles face refusal of admission at the port of U.S. entry. In addition, their FDA registration may be suspended.
How Can I Prevent Being Deemed a Refusal?
The recent guidance amplifies the importance of understanding FDA’s expectations for the inspection process and having a reliable U.S. Agent as a guide. Before the inspection begins, the Agency may interpret actions such as not agreeing to an inspection start date or rescheduling an inspection without reasonable explanation as attempts to circumvent the inspection. Upon receiving a notice of inspection, a facility should work with their U.S. Agent to respond to FDA promptly and cooperatively.
During the inspection, a facility should maintain this cooperation with the FDA inspector. Any attempts to interfere with or delay the inspection, such as limiting the inspector’s observations to certain areas of the plant or omitting requested documents, may constitute refusal. Facilities should ensure that they accommodate the inspector’s requests and refrain from any actions that might limit a full observation of daily operations.
Our Facility Is Under Import Alert for Inspection Refusal. What Can We Do?
To seek removal from the Import Alert 99-32 Red List, a facility must petition for inspection by FDA. The guidance states that for some facilities, scheduling an inspection after an initial refusal may take at least one year. Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.
Proper guidance from a third party experienced in FDA regulations can prove invaluable to a facility facing inspection. Registrar Corp’s trained Regulatory Specialists are knowledgeable in FDA inspections and can conduct a Mock FDA Inspection of your facility. Our experts can help identify potential food safety issues to fix before an inspection and educate facility staff on FDA expectations. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
Registrar Corp can act as your U.S. Agent to help you promptly schedule inspection with FDA, as well as provide your facility a host of additional benefits, including biennial registration, detention assistance, and compliance monitoring.
WHY FOOD FACILITIES SHOULD GET OFF FDA IMPORT ALERT BEFORE MARCH 2018
The U.S. Food and Drug Administration (FDA) requires most U.S. importers of food and beverages to develop and implement Foreign Supplier Verification Programs (FSVPs). Covered importers must document their foreign suppliers’ FDA compliance, including whether or not each supplier is subject to a FDA Import Alert.
Under FSVP, importers must only import from suppliers whom they have evaluated and approved. FDA requires verification activities outlined in a FSVP to be decided by the level of supplier risk determined from this evaluation. An Import Alert increases the probability that the importer must conduct more comprehensive verification activities to ensure the safety of a supplier’s products, such as onsite audits or sampling. In some cases, the importer may be unable to approve a supplier because they are under Import Alert. For these reasons, suppliers not on alert receive a competitive advantage in the market.
The next FSVP deadline is March 19, 2018, which applies to U.S. importers whose suppliers have fewer than 500 full-time equivalent employees. Before the deadline, food facilities outside of the United States should ensure that they are not subject to an Import Alert that may cause their U.S. Importers to not approve them.
What is an Import Alert?
Products on Import Alert face detention without physical examination (DWPE) at the port of entry. FDA issues Import Alerts when patterns of non-compliance from a specific business or country give the Agency reasonable belief that future shipments may violate regulations.
For example, FDA sampled 16 shipments of dried peppers from ten different shippers in Mexico in 1988. FDA found excessive mold in 14 of those samples. This led to the publication of Import Alert #24-11, which subjects all shipments of dried peppers from Mexico to DWPE unless the shipper’s product is exempt. This is just one instance of over 240 active FDA Import Alerts.
How do I know if my products are on Import Alert?
FDA does not directly notify a facility that it is under Import Alert. Instead, the Agency maintains a public database of Import Alerts with records of which products from which facilities are subject to DWPE. However, determining if products are on Import Alert may require time-consuming searches through numerous alerts for any facilities a given business might have a stake in. Registrar Corp’s FDA Compliance Monitor is a simple alternative that allows businesses to track all of their facilities at once and receive a detailed report of any alerts their products may be under.
My Products are on Import Alert. How do I get them removed?
A business may petition FDA for exclusion from an Import Alert by demonstrating evidence of compliance that overcomes the apparent violation detailed in the Alert. A common misconception is that a facility is excluded from Import Alert after five consecutive non-violative shipments are released by FDA. This is only a small component of a larger process involving other, potentially extensive requirements.
The specific requirements for a petition vary, and are outlined in the guidance issued with an individual Import Alert. These may include documentation of revised food safety plans, revised labeling or formulations, changes implemented in the manufacturing process, or documentation of compliance with a government agency regulating food in the facility’s home country.
Many businesses can be intimidated by the extensive requirements of an Import Alert petition. These businesses may remain under Import Alert, facing DWPE and difficulties satisfying the requirements of an importer’s FSVP, even if they are not in violation of the specified regulations at the time. Despite a solution to the problem, some businesses might have no idea how to begin a petition.
Registrar Corp’s Regulatory Specialists are experienced in developing Import Alert petitions and can help you draft and compile the necessary documentation for Import Alert exclusion. Additionally, importers and suppliers can try Registrar Corp’s FDA Compliance Monitor free for 60 days to see which of their facilities may be on alert.

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UPCOMING CHANGES TO FDA ELECTRONIC MEDICAL DEVICE REPORTING (EMDR) IN 2018
Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An “adverse event” is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The U.S. Food and Drug Administration (FDA) has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.
The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).
IMDRF has released public references to help map FDA codes to the new codes during the interim before the update. For example, the current FDA Device Problem Code 2682 refers to an “issue associated with the interaction between the patient’s physiology or anatomy and the device that affects patient and/or device.” This code corresponds to and will be replaced by IMDRF code A0101, a “problem associated with the interaction between the patient’s physiology or anatomy and the device that affects the patient and/or the device.”
Despite this mapping, reporting parties will not be able to rely on FDA codes after the update. Some IMDRF codes do not have a current FDA equivalent, and FDA has further stated that the submission of retired FDA codes following the update will be rejected by the eMDR system. As such, reporting parties should familiarize themselves with the IMDRF codes for a smooth transition into these changes.
If you are a reporting party in need of assistance, Registrar Corp can guide you through the eSubmitter software and facilitate your Adverse Event Report submission to eMDR. Registrar Corp offers Adverse Event Reporting assistance at no fee to clients of our U.S. Agent Service. Call us at +1-757-224-0177.
FDA RELEASES FY 2017 INSPECTIONAL OBSERVATIONS; REGISTRAR CORP REPORTS ON COMMON FOOD SAFETY VIOLATIONS
The U.S. Food and Drug Administration (FDA) recently released its inspectional observation data for fiscal year (FY) 2017. The data presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017. FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:
Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs). Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan’s hazard control, or maintaining records as required by 21 CFR Part 123
Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food. Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.
The violations listed above are nearly identical to the most common violations cited in FY 2016 and FY 2015. Food facilities should use this pattern to anticipate what areas in their daily operations may require further review before a FDA inspection.
It is worth mentioning that the 2017 list is the first to include violations related to FDA’s Preventive Controls Rules and Foreign Supplier Verification Program (FSVP) Rule, both of which had compliance deadlines in 2017. Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times. With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.
Inspection violations can result in Warning Letters, placement on Import Alert, suspension of facility registration, and other enforcement actions. With proper preparation and guidance, these food safety issues can be corrected before FDA visits a facility. Registrar Corp’s Food Safety Specialists can conduct a mock FDA inspection of your facility to identify potential food safety violations. Our expert, onsite assistance can guide your facility with knowledge and tools to have a successful FDA inspection.

FDA ISSUES FINAL RULE ON SAFETY AND EFFECTIVENESS OF TRICLOSAN IN HEALTH CARE ANTISEPTICS
On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments. Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA). You will find a list of the covered ingredients below.
The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings. Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017
Why are these ingredients prohibited?
The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products. A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products. FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).
FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.
Not sure how this rule applies to your health care antiseptics? Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling. We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations. In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes. For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule:orhexidine gluconate
Mercufenol chloride
Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol
Hexachlorophene
Secondary amyltricresols
Hexylresorcinol
Sodium oxychlorosene
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Tribromsalan
Triclocarban
Triclosan
Triple dye
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol
FDA ANNOUNCES NEW ENFORCEMENT APPROACH TO DRUGS LABELED AS HOMEOPATHIC
Once small and specialized, homeopathic drugs now comprise a nearly $3 billion industry. Following an increase in reported health concerns stemming from these products and a flurry of unsubstantiated health claims surrounding the industry, the U.S. Food and Drug Administration (FDA) is taking new measures to curb the widespread distribution of potentially harmful drugs labeled as homeopathic.
What are Homeopathic Drugs?
Homeopathy is a form of alternative medicine based on the principle of remedying health conditions using diluted solutions of substances that produce similar symptoms in a healthy patient.
The Food, Drug, and Cosmetic (FD&C) Act defines articles recognized in the official Homeopathic Pharmacopoeia of the United States as drugs. FDA states that homeopathic drugs “are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.”
Despite this, the uniqueness of homeopathic drugs delayed them from the 1972 over-the-counter (OTC) drug review, which determined the safety and effectiveness of most OTC drugs on the U.S. market. Even now, FDA has not conducted a formal review of homeopathic drugs. Since 1988, a FDA Compliance Policy Guide (CPG) establishes provisions under which these products may be marketed without the prior FDA approval required of other drug products.
Why is FDA Cracking Down on Homeopathic Drugs?
Numerous homeopathic drugs contain potentially harmful ingredients. As recently as September 2017, a homeopathic drug facility received a Warning Letter, citing failure to establish adequate in-process controls for products containing multiple potentially toxic ingredients. One such ingredient was Nux vomica, a plant bearing constituents commonly used for rat poison.
Throughout 2017, FDA issued at least four additional letters to homeopathic drug manufacturers who failed to adequately test and control potentially toxic substances in their products. FDA charged the drugs in question as adulterated.
New Enforcement Approaches to Homeopathic Drugs
In addition to FDA, the U.S. Federal Trade Commission (FTC) has issued measures to mitigate the prevalence of unsubstantiated health claims made by homeopathic drug manufacturers. A 2016 FTC Enforcement Policy Statement requires homeopathic drug labeling to communicate that “there is no scientific evidence that the product works.” The label must also indicate that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
A December 2017 FDA draft guidance explains that the Agency intends to prioritize enforcement on products that are known to cause harm to patients, including those with reported health issues and those deemed adulterated under section 501 of the FD&C Act.
FDA states it will also focus increased attention on homeopathic drugs with less overt health concerns. According to the guidance, unapproved drugs intended to treat serious or life-threatening conditions may cause a patient to delay or discontinue treatment already generally recognized as safe and effective (GRASE). Homeopathic drugs designed for vulnerable populations (e.g. infants and the elderly) may pose significant health risks even in small concentrations, in spite of treatments that have already been determined GRASE. For this reason, these drug categories may see increased regulatory enforcement.
In the previously referenced Warning Letters, FDA maintains that “nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.” The letters and newly issued guidance suggest that FDA intends to expand efforts to hold homeopathic drug manufacturers accountable to the regulations derived from the FD&C Act.
Registrar Corp is a consulting firm that assists drug companies with U.S. FDA regulations. Our Regulatory Specialists can assist with FDA registration and drug listing, labeling requirements, and other drug regulations. For assistance or questions call +1-757-224-0177.

2017 IN REVIEW – U.S. FDA FOOD AND BEVERAGE REGULATIONS
2017 brought a host of changes for food manufacturers and importers. The U.S. Food and Drug Administration (FDA) had a year of announcements, proposals, and deadlines for the food and beverage industry. Perhaps most notable were the passing of two compliance dates for rules under the Food Safety Modernization Act (FSMA) and a proposed extension of the compliance date for FDA’s new food label rules. Take a look below at some of the regulatory highlights that occurred this year.
FDA Removed 28% of Food Facility Registrations from its Database
Between January 2016 and February 2017, FDA removed 57,720 food facility registrations from its database. The drop in registrations was likely caused by facilities not properly registering before the December 2016 deadline and U.S. Agents of foreign facilities not confirming acceptance of this role with FDA.
Australia Received Systems Recognition with U.S. FDA
In April, FDA recognized the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System to the United States. Australia follows New Zealand and Canada as the third country to receive this recognition. U.S. Importers may receive exemptions from certain requirements in their Foreign Supplier Verification Programs (FSVPs) if their suppliers are in “good compliance standing” with a recognized country’s regulating authority.
As of this writing, the three recognized countries have not published lists of firms in good compliance standing. As a result, suppliers in these countries are unable to benefit from the competitive advantage that more relaxed FSVP requirements for importers would grant them.
The FSVP Compliance Deadline for Most US Importers Passed
The first compliance deadline for the FSVP Rule passed on May 30, 2017. Among other requirements, covered importers must monitor and document their foreign suppliers’ FDA compliance, evaluate the level of health risk their suppliers pose, and conduct appropriate verification activities relative to this evaluation. In August, FDA began inspecting covered importers for their compliance with FSVP requirements. The next FSVP compliance date is March 19, 2018.
Compliance Dates Passed under the Preventive Controls Rules
Larger animal food and smaller human food businesses were required to develop and implement written Food Safety Plans by September 18, 2017. These plans, overseen by a “Preventive Controls Qualified Individual” (PCQI), involve an analysis of reasonably known or foreseeable hazards and preventive controls for these hazards. Smaller animal food businesses were required to begin implementing Current Good Manufacturing Practices (CGMPs) by this deadline.
FDA Proposed Extension of Label Rule Compliance Dates
In September, FDA proposed an extension of the compliance deadline for new food labeling rules to January 1, 2020 for food manufacturers grossing $10 million or more in annual sales. Smaller businesses would be provided an additional year. Despite the proposed extension, we urge facilities to take steps toward compliance now. FDA issued this proposal after manufacturers expressed concerns over being able to comply with the initial deadline of July 2018.
FDA Proposed to Revoke Authorized Health Claim for Soy Protein
FDA issued a proposal to revoke an authorized health claim linking soy protein to a decreased risk of coronary heart disease. Since the claim’s authorization in 1999, the “totality of scientific evidence” surrounding the relationship has yielded inconsistent findings. This caused FDA to determine that it did not present the significant scientific agreement required of an authorized health claim.
FDA Issued Draft Guidance for Refusal of Inspection
In December, FDA issued a guidance outlining the Agency’s interpretation of the term “refusal of inspection.” FDA states that, among other actions, failure to respond to an inspection request within 24 hours may constitute a refusal. Food facilities that refuse inspection are placed under Import Alert, and their products are refused at the port of U.S. entry.
Registrar Corp remains committed to keeping the food industry informed on pressing regulatory matters and will continue to issue critical information in 2018. The numerous requirements that came into effect this year and those approaching in 2018 may be overwhelming. Registrar Corp can offer assistance.

U.S. FDA FOOD, BEVERAGE, AND SUPPLEMENT LABELING REQUIREMENTS

In May 2016, the U.S. Food and Drug Administration (FDA) finalized significant changes to food, beverage, and supplement labeling, including updates to daily values, serving sizes, the Nutrition Facts chart, and more. Most food labelers must comply by no later than January 1, 2020.

Start early to avoid a surplus of non-compliant inventory. Have Registrar Corp update your labeling to be compliant with FDA’s new regulations.

Labeling errors are one of the leading causes of detentions by FDA. Registrar Corp’s Regulatory Specialists can review and edit your food, beverage, and supplement labeling for compliance with U.S. FDA regulations. Registrar Corp provides:

A detailed report (typically 60-80 pages) prepared by our team of Regulatory Specialists who scrutinize every element of your food labeling.

A print-ready graphic file of your revised food label which incorporates our recommended changes.

A generous revision policy providing additional changes for your revised food label within 45 days at no extra cost.

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2017 IN REVIEW – U.S. FDA MEDICAL DEVICE AND DRUG REGULATIONS
The medical device and drug industries saw numerous regulatory developments in 2017. The U.S. Food and Drug Administration (FDA) introduced new requirements, fees, deadline extensions, and exemptions. Below, Registrar Corp provides an overview of regulatory highlights this year.
FDA Removed Medical Device and Drug Establishments that Did Not Register for 2017
Medical device and drug establishments that failed to properly renew their registrations for 2017 were removed from FDA’s active registration database. The Agency will likely do the same in 2018. Marketing medical devices and drugs without a valid registration is a prohibited act that may be met with seizure and injunction.
FDA Extended the UDI Compliance Date for Class I Devices to 2020
FDA issued a letter in June announcing its intention to extend the universal device identifier (UDI) compliance dates for class I and unclassified devices. The letter proposes to push the UDI labeling compliance date for these devices to September 24, 2020.
FDA Exempted Certain Class II Devices from 510k
In July, FDA exempted certain class II medical devices from premarket notification (510k) requirements. The exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.”
The Compliance Date Passed for the Consumer Antiseptic Wash Final Rule
As of September, over-the-counter (OTC) consumer antiseptic washes containing any of nineteen certain ingredients are not permitted to enter interstate commerce without approval of a new drug application (NDA). FDA made this determination after discovering there was insufficient evidence to support the ingredients’ safety and effectiveness for their intended use.
FDA Published FY 2018 User Fees for Medical Devices and Generic Drugs
The Medical Device User Fee Amendments (MDUFA) and Generic Drug User Fee Amendments (GDUFA) were reauthorized for fiscal year (FY) 2018. The amendments introduced differences in rates from FY 2017, as well as new types of fees for certain facilities and submissions.
FDA Introduced a New Verification Requirement for U.S. Agents of Medical Device Establishments
The U.S. Agent of medical device establishments located outside of the United States is now required to confirm this role with FDA. Agents must accept their designation through the FDA Unified Registration and Listing System (FURLS). If the Agent does not respond to a verification email within ten days, the establishment will need to designate a new Agent.
FDA Introduced Annual Certification Requirement for Unchanged Drug Listings
The 2017 registration renewal period introduced a requirement for drug establishments to submit a “blanket no-change” certification for drug listings that did not receive any changes to data or labeling during the year. Certifications must be submitted in structured product labeling (SPL) format.
FDA Published Final Guidance for UDI Direct Marking Requirements
In November, FDA issued a final guidance to clarify a device labeler’s responsibilities for UDI direct marking requirements. Class II devices must comply with direct marking requirements by September 24, 2018. During a December webinar, FDA stated that they do not intend to enforce these requirements for class I and unclassified devices until September 24, 2022.
FDA Issued a Final Rule on the Safety and Effectiveness of Triclosan in Health Care Antiseptics
FDA finalized a rule prohibiting the use of Triclosan and 23 other active ingredients in OTC antiseptics for health care environments. After December 20, 2018, health care antiseptics containing these ingredients will not be permitted to enter interstate commerce without FDA approval of an NDA.
As we cross into 2018, Registrar Corp will continue to keep the medical device and drug industries informed about important FDA regulations. For assistance with FDA requirements in either industry, call us at +1-757-224-0177

Monday, 1 January 2018