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Bernand Simanjuntak — Thu, 24 Nov 2011 01:59:00 +0000

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Antioxidants and Cancer Prevention: Fact Sheet

Bernand Simanjuntak — Tue, 05 May 2009 10:39:18 +0000

1. What are antioxidants?

Antioxidants are substances that may protect cells from the damage caused by unstable molecules known as free radicals. Free radical damage may lead to cancer. Antioxidants interact with and stabilize free radicals and may prevent some of the damage free radicals otherwise might cause. Examples of antioxidants include beta-carotene, lycopene, vitamins C, E, and A, and other substances.

2. Can antioxidants prevent cancer?

Considerable laboratory evidence from chemical, cell culture, and animal studies indicates that antioxidants may slow or possibly prevent the development of cancer. However, information from recent clinical trials is less clear. In recent years, large-scale, randomized clinical trials reached inconsistent conclusions.

3. What was shown in previously published large-scale clinical trials?

Five large-scale clinical trials published in the 1990s reached differing conclusions about the effect of antioxidants on cancer. The studies examined the effect of beta-carotene and other antioxidants on cancer in different patient groups. However, beta-carotene appeared to have different effects depending upon the patient population. The conclusions of each study are summarized below.

• The first large randomized trial on antioxidants and cancer risk was the Chinese Cancer Prevention Study, published in 1993. This trial investigated the effect of a combination of beta-carotene, vitamin E, and selenium on cancer in healthy Chinese men and women at high risk for gastric cancer. The study showed a combination of beta-carotene, vitamin E, and selenium significantly reduced incidence of both gastric cancer and cancer overall. (1)

• A 1994 cancer prevention study entitled the Alpha-Tocopherol (vitmain E)/Beta-Carotene Cancer Prevention Study (ATBC) demonstrated that lung cancer rates of Finnish male smokers increased significantly with beta-carotene and were not affected by vitamin E. (2)

• Another 1994 study, the Beta-Carotene and Retinol (vitamin A) Efficacy Trial (CARET), also demonstrated a possible increase in lung cancer associated with antioxidants. (3)

• The 1996 Physicians’ Health Study I (PHS) found no change in cancer rates associated with beta-carotene and aspirin taken by U.S. male physicians. (4)

• The 1999 Women’s Health Study (WHS) tested effects of vitamin E and beta-carotene in the prevention of cancer and cardiovascular disease among women age 45 years or older. Among apparently healthy women, there was no benefit or harm from beta-carotene supplementation. Investigation of the effect of vitamin E is ongoing. (5)

4. Are antioxidants under investigation in current large-scale clinical trials?

Three large-scale clinical trials continue to investigate the effect of antioxidants on cancer. The objective of each of these studies is described below.

• The Women’s Health Study (WHS) is currently evaluating the effect of vitamin E in the primary prevention of cancer among U.S. female health professionals age 45 and older. The WHS is expected to conclude in August 2004.

• The Selenium and Vitamin E Cancer Prevention Trial (SELECT) is taking place in the United States, Puerto Rico, and Canada. SELECT is trying to find out if taking selenium and/or vitamin E supplements can prevent prostate cancer in men age 50 or older. The SELECT trial is expected to stop recruiting patients in May 2006.

• The Physicians’ Health Study II (PHS II) is a follow up to the earlier clinical trial by the same name. The study is investigating the effects of vitamin E, C, and multivitamins on prostate cancer and total cancer incidence. The PHS II is expected to conclude in August 2007.

5. Will NCI continue to investigate the effect of beta-carotene on cancer?

Given the unexpected results of ATBC and CARET, and the finding of no effect of beta-carotene in the PHS and WHS, NCI will follow the people who participated in these studies and will examine the long-term health effects of beta-carotene supplements. Post-trial follow-up has already been funded by NCI for CARET, ATBC, the Chinese Cancer Prevention Study, and the two smaller trials of skin cancer and colon polyps. Post-trial follow-up results have been published for ATBC, and as of July 2004 are in press for CARET and are in progress for the Chinese Cancer Prevention Study.

6. How might antioxidants prevent cancer?

Antioxidants neutralize free radicals as the natural by-product of normal cell processes. Free radicals are molecules with incomplete electron shells which make them more chemically reactive than those with complete electron shells. Exposure to various environmental factors, including tobacco smoke and radiation, can also lead to free radical formation. In humans, the most common form of free radicals is oxygen. When an oxygen molecule (O2) becomes electrically charged or “radicalized” it tries to steal electrons from other molecules, causing damage to the DNA and other molecules. Over time, such damage may become irreversible and lead to disease including cancer. Antioxidants are often described as “mopping up” free radicals, meaning they neutralize the electrical charge and prevent the free radical from taking electrons from other molecules.

7. Which foods are rich in antioxidants?

Antioxidants are abundant in fruits and vegetables, as well as in other foods including nuts, grains and some meats, poultry and fish. The list below describes food sources of common antioxidants.

• Beta-carotene is found in many foods that are orange in color, including sweet potatoes, carrots, cantaloupe, squash, apricots, pumpkin, and mangos. Some green leafy vegetables including collard greens, spinach, and kale are also rich in beta-carotene.

• Lutein, best known for its association with healthy eyes, is abundant in green, leafy vegetables such as collard greens, spinach, and kale.

• Lycopene is a potent antioxidant found in tomatoes, watermelon, guava, papaya, apricots, pink grapefruit, blood oranges, and other foods. Estimates suggest 85 percent of American dietary intake of lycopene comes from tomatoes and tomato products.

• Selenium is a mineral, not an antioxidant nutrient. However, it is a component of antioxidant enzymes. Plant foods like rice and wheat are the major dietary sources of selenium in most countries. The amount of selenium in soil, which varies by region, determines the amount of selenium in the foods grown in that soil. Animals that eat grains or plants grown in selenium-rich soil have higher levels of selenium in their muscle. In the United States, meats and bread are common sources of dietary selenium. Brazil nuts also contain large quantities of selenium.

• Vitamin A is found in three main forms: retinol (Vitamin A1), 3,4-didehydroretinol (Vitamin A2), and 3-hydroxy-retinol (Vitamin A3). Foods rich in vitamin A include liver, sweet potatoes, carrots, milk, egg yolks and mozzarella cheese.

• Vitamin C is also called ascorbic acid, and can be found in high abundance in many fruits and vegetables and is also found in cereals, beef, poultry and fish.

• Vitamin E, also known as alpha-tocopherol, is found in almonds, in many oils including wheat germ, safflower, corn and soybean oils, and also found in mangos, nuts, broccoli and other foods.

References:

1) Blot WJ, Li JY, Taylor PR, et al. Nutrition intervention trials in Linxian, China: supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population. J Natl Cancer Inst 1993;85:1483-91.

2) The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effects of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med 1994;330:1029-35.

3) Omenn GS, Goodman G, Thomquist M, et al. The beta-carotene and retinol efficacy trial (CARET) for chemoprevention of lung cancer in high risk populations: smokers and asbestos-exposed workers. Cancer Res 1994;54(7 Suppl):2038s-43s.

4) Hennekens CH, Buring JE, Manson JE, Stampfer M, Rosner B, Cook NR, et al. Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. N Engl J Med 1996;334:1145-9.

5) Lee IM, Cook NR, Manson JE. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: Women’s Health Study. J Natl Cancer Inst 1999;91:2102-6.

Seafoods Nutrition Facts

Bernand Simanjuntak — Sun, 05 Apr 2009 08:04:34 +0000

Vegetables Nutrition Facts

Bernand Simanjuntak — Sun, 05 Apr 2009 07:54:02 +0000

Fruits Nutrition Facts

Bernand Simanjuntak — Sun, 05 Apr 2009 07:32:39 +0000

Nutrition Facts Label

Bernand Simanjuntak — Sun, 05 Apr 2009 06:59:36 +0000

People look at food labels for different reasons. But whatever the reason, many consumers would like to know how to use this information more effectively and easily. The following label-building skills are intended to make it easier for you to use nutrition labels to make quick, informed food choices that contribute to a healthy diet.

The Nutrition Facts Label – An Overview:

The information in the main or top section (see #1-4 and #6 on the sample nutrition label below), can vary with each food product; it contains product-specific information (serving size, calories, and nutrient information). The bottom part (see #5 on the sample label below) contains a footnote with Daily Values (DVs) for 2,000 and 2,500 calorie diets. This footnote provides recommended dietary information for important nutrients, including fats, sodium and fiber. The footnote is found only on larger packages and does not change from product to product.

In the following Nutrition Facts label we have colored certain sections to help you focus on those areas that will be explained in detail. You will not see these colors on the food labels on products you purchase.

The Serving Size

(#1 on sample label):
The first place to start when you look at the Nutrition Facts label is the serving size and the number of servings in the package. Serving sizes are standardized to make it easier to compare similar foods; they are provided in familiar units, such as cups or pieces, followed by the metric amount, e.g., the number of grams.

The size of the serving on the food package influences the number of calories and all the nutrient amounts listed on the top part of the label. Pay attention to the serving size, especially how many servings there are in the food package. Then ask yourself, “How many servings am I consuming”? (e.g., 1/2 serving, 1 serving, or more) In the sample label, one serving of macaroni and cheese equals one cup. If you ate the whole package, you would eat two cups. That doubles the calories and other nutrient numbers, including the %Daily Values as shown in the sample label.

Example
	Single Serving	%DV	Double Serving	%DV
Serving Size	1 cup (228g)		2 cups (456g)
Calories	250		500
Calories from Fat	110		220
Total Fat	12g	18%	24g	36%
Trans Fat	1.5g		3g
Saturated Fat	3g	15%	6g	30%
Cholesterol	30mg	10%	60mg	20%
Sodium	470mg	20%	940mg	40%
Total Carbohydrate	31g	10%	62g	20%
Dietary Fiber	0g	0%	0g	0%
Sugars	5g		10g
Protein	5g		10g
Vitamin A		4%		8%
Vitamin C		2%		4%
Calcium		20%		40%
Iron		4%		8%

Calories (and Calories from Fat)

Calories provide a measure of how much energy you get from a serving of this food. Many Americans consume more calories than they need without meeting recommended intakes for a number of nutrients. The calorie section of the label can help you manage your weight (i.e., gain, lose, or maintain.) Remember: the number of servings you consume determines the number of calories you actually eat (your portion amount).

(#2 on sample label):
In the example, there are 250 calories in one serving of this macaroni and cheese. How many calories from fat are there in ONE serving? Answer: 110 calories, which means almost half the calories in a single serving come from fat. What if you ate the whole package content? Then, you would consume two servings, or 500 calories, and 220 would come from fat.

General Guide to Calories

40 Calories is low
100 Calories is moderate
400 Calories or more is high

The General Guide to Calories provides a general reference for calories when you look at a Nutrition Facts label. This guide is based on a 2,000 calorie diet.

Eating too many calories per day is linked to overweight and obesity.

The Nutrients: How Much?

(#3 and 4 on sample label):
Look at the top of the nutrient section in the sample label. It shows you some key nutrients that impact on your health and separates them into two main groups:

Limit These Nutrients

(#3 on sample label):
The nutrients listed first are the ones Americans generally eat in adequate amounts, or even too much. They are identified in yellow as Limit these Nutrients. Eating too much fat, saturated fat, trans fat, cholesterol, or sodium may increase your risk of certain chronic diseases, like heart disease, some cancers, or high blood pressure.

Important: Health experts recommend that you keep your intake of saturated fat, trans fat and cholesterol as low as possible as part of a nutritionally balanced diet.

Get Enough of These

(#4 on sample label):
Most Americans don’t get enough dietary fiber, vitamin A, vitamin C, calcium, and iron in their diets. They are identified in blue as Get Enough of these Nutrients. Eating enough of these nutrients can improve your health and help reduce the risk of some diseases and conditions. For example, getting enough calcium may reduce the risk of osteoporosis, a condition that results in brittle bones as one ages (see calcium section below). Eating a diet high in dietary fiber promotes healthy bowel function. Additionally, a diet rich in fruits, vegetables, and grain products that contain dietary fiber, particularly soluble fiber, and low in saturated fat and cholesterol may reduce the risk of heart disease.

Remember: You can use the Nutrition Facts label not only to help limit those nutrients you want to cut back on but also to increase those nutrients you need to consume in greater amounts.

Understanding the Footnote on the Bottom of the Nutrition Facts Label

(#5 on sample label)
Note the * used after the heading “%Daily Value” on the Nutrition Facts label. It refers to the Footnote in the lower part of the nutrition label, which tells you “%DVs are based on a 2,000 calorie diet“. This statement must be on all food labels. But the remaining information in the full footnote may not be on the package if the size of the label is too small. When the full footnote does appear, it will always be the same. It doesn’t change from product to product, because it shows recommended dietary advice for all Americans–it is not about a specific food product.

Look at the amounts circled in red in the footnote–these are the Daily Values (DV) for each nutrient listed and are based on public health experts’ advice. DVs are recommended levels of intakes. DVs in the footnote are based on a 2,000 or 2,500 calorie diet. Note how the DVs for some nutrients change, while others (for cholesterol and sodium) remain the same for both calorie amounts.

How the Daily Values Relate to the %DVs

Look at the example below for another way to see how the Daily Values (DVs) relate to the %DVs and dietary guidance. For each nutrient listed there is a DV, a %DV, and dietary advice or a goal. If you follow this dietary advice, you will stay within public health experts’ recommended upper or lower limits for the nutrients listed, based on a 2,000 calorie daily diet.

Examples of DVs versus %DVs
Based on a 2,000 Calorie Diet

Nutrient	DV	%DV	Goal
Total Fat	65g	= 100%DV	Less than
Sat Fat	20g	= 100%DV	Less than
Cholesterol	300mg	= 100%DV	Less than
Sodium	2400mg	= 100%DV	Less than
Total Carbohydrate	300g	= 100%DV	At least
Dietary Fiber	25g	= 100%DV	At least

Upper Limit – Eat “Less than”…

The nutrients that have “upper daily limits” are listed first on the footnote of larger labels and on the example above. Upper limits means it is recommended that you stay below – eat “less than” – the Daily Value nutrient amounts listed per day. For example, the DV for Saturated fat (in the yellow section) is 20g. This amount is 100% DV for this nutrient. What is the goal or dietary advice? To eat “less than” 20 g or 100%DV for the day.<

Lower Limit – Eat “At least”…

Now look at the section in blue where dietary fiber is listed. The DV for dietary fiber is 25g, which is 100% DV. This means it is recommended that you eat “at least” this amount of dietary fiber per day.

The DV for Total Carbohydrate (section in white) is 300g or 100%DV. This amount is recommended for a balanced daily diet that is based on 2,000 calories, but can vary, depending on your daily intake of fat and protein.

Now let’s look at the %DVs.

The Percent Daily Value (%DV):

The % Daily Values (%DVs) are based on the Daily Value recommendations for key nutrients but only for a 2,000 calorie daily diet–not 2,500 calories. You, like most people, may not know how many calories you consume in a day. But you can still use the %DV as a frame of reference whether or not you consume more or less than 2,000 calories.

The %DV helps you determine if a serving of food is high or low in a nutrient. Note: a few nutrients, like trans fat, do not have a %DV–they will be discussed later.

Do you need to know how to calculate percentages to use the %DV? No, the label (the %DV) does the math for you. It helps you interpret the numbers (grams and milligrams) by putting them all on the same scale for the day (0-100%DV). The %DV column doesn’t add up vertically to 100%. Instead each nutrient is based on 100% of the daily requirements for that nutrient (for a 2,000 calorie diet). This way you can tell high from low and know which nutrients contribute a lot, or a little, to your daily recommended allowance (upper or lower).

Quick Guide to %DV:

5%DV or less is low and 20%DV or more is high
(#6 on sample label):
This guide tells you that 5%DV or less is low for all nutrients, those you want to limit (e.g., fat, saturated fat, cholesterol, and sodium), or for those that you want to consume in greater amounts (fiber, calcium, etc). As the Quick Guide shows, 20%DV or more is high for all nutrients.

Example: Look at the amount of Total Fat in one serving listed on the sample nutrition label. Is 18%DV contributing a lot or a little to your fat limit of 100% DV? Check the Quick Guide to %DV. 18%DV, which is below 20%DV, is not yet high, but what if you ate the whole package (two servings)? You would double that amount, eating 36% of your daily allowance for Total Fat. Coming from just one food, that amount leaves you with 64% of your fat allowance (100%-36%=64%) for all of the other foods you eat that day, snacks and drinks included.

1 serving
2 servings

Using the %DV for:

Comparisons: The %DV also makes it easy for you to make comparisons. You can compare one product or brand to a similar product. Just make sure the serving sizes are similar, especially the weight (e.g. gram, milligram, ounces) of each product. It’s easy to see which foods are higher or lower in nutrients because the serving sizes are generally consistent for similar types of foods, (see the comparison example at the end) except in a few cases like cereals.

Nutrient Content Claims: Use the %DV to help you quickly distinguish one claim from another, such as “reduced fat” vs. “light” or “nonfat.” Just compare the %DVs for Total Fat in each food product to see which one is higher or lower in that nutrient–there is no need to memorize definitions. This works when comparing all nutrient content claims, e.g., less, light, low, free, more, high, etc.

Dietary Trade-Offs: You can use the %DV to help you make dietary trade-offs with other foods throughout the day. You don’t have to give up a favorite food to eat a healthy diet. When a food you like is high in fat, balance it with foods that are low in fat at other times of the day. Also, pay attention to how much you eat so that the total amount of fat for the day stays below 100%DV.

Nutrients With a %DV but No Weight Listed – Spotlight on Calcium:

Calcium: Look at the %DV for calcium on food packages so you know how much one serving contributes to the total amount you need per day. Remember, a food with 20%DV or more contributes a lot of calcium to your daily total, while one with 5%DV or less contributes a little.

Experts advise adult consumers to consume adequate amounts of calcium, that is, 1,000mg or 100%DV in a daily 2,000 calorie diet. This advice is often given in milligrams (mg), but the Nutrition Facts label only lists a %DV for calcium.

For certain populations, they advise that adolescents, especially girls, consume 1,300mg (130%DV) and post-menopausal women consume 1,200mg (120%DV) of calcium daily. The DV for calcium on food labels is 1,000mg.

Don’t be fooled — always check the label for calcium because you can’t make assumptions about the amount of calcium in specific food categories. Example: the amount of calcium in milk, whether skim or whole, is generally the same per serving, whereas the amount of calcium in the same size yogurt container (8oz) can vary from 20-45 %DV.

Equivalencies

30% DV = 300mg calcium = one cup of milk

100% DV = 1,000mg calcium

130% DV = 1,300mg calcium

Nutrients Without a %DV: Trans Fats, Protein, and Sugars:

Note that Trans fat, Sugars and, Protein do not list a %DV on the Nutrition Facts label.

Plain Yogurt

Fruit Yogurt

Trans Fat: Experts could not provide a reference value for trans fat nor any other information that FDA believes is sufficient to establish a Daily Value or %DV. Scientific reports link trans fat (and saturated fat) with raising blood LDL (“bad”) cholesterol levels, both of which increase your risk of coronary heart disease, a leading cause of death in the US.

Important: Health experts recommend that you keep your intake of saturated fat, trans fat and cholesterol as low as possible as part of a nutritionally balanced diet.

Protein: A %DV is required to be listed if a claim is made for protein, such as “high in protein”. Otherwise, unless the food is meant for use by infants and children under 4 years old, none is needed. Current scientific evidence indicates that protein intake is not a public health concern for adults and children over 4 years of age.

Sugars: No daily reference value has been established for sugars because no recommendations have been made for the total amount to eat in a day. Keep in mind, the sugars listed on the Nutrition Facts label include naturally occurring sugars (like those in fruit and milk) as well as those added to a food or drink. Check the ingredient list for specifics on added sugars.

Take a look at the Nutrition Facts label for the two yogurt examples. The plain yogurt on the left has 10g of sugars, while the fruit yogurt on the right has 44g of sugars in one serving.

Now look below at the ingredient lists for the two yogurts. Ingredients are listed in descending order of weight (from most to least). Note that no added sugars or sweeteners are in the list of ingredients for the plain yogurt, yet 10g of sugars were listed on the Nutrition Facts label. This is because there are no added sugars in plain yogurt, only naturally occurring sugars (lactose in the milk).

Plain Yogurt – contains no added sugars

Fruit Yogurt – contains added sugars

If you are concerned about your intake of sugars, make sure that added sugars are not listed as one of the first few ingredients. Other names for added sugars include: corn syrup, high-fructose corn syrup, fruit juice concentrate, maltose, dextrose, sucrose, honey, and maple syrup.

To limit nutrients that have no %DV, like trans fat and sugars, compare the labels of similar products and choose the food with the lowest amount.

Comparison Example

REDUCED FAT MILK 2% Milkfat
Below are two kinds of milk- one is “Reduced Fat,” the other is “Nonfat” milk. Each serving size is one cup. Which has more calories and more saturated fat? Which one has more calcium?

NONFAT MILK

Answer: As you can see, they both have the same amount of calcium, but the nonfat milk has no saturated fat and has 40 calories less per serving than the reduced fat milk.

Melamine Contamination in China

Bernand Simanjuntak — Sun, 05 Apr 2009 06:33:06 +0000

On September 12, 2008, in light of reports from China of infant formula contaminated with melamine, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Asian communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. No Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States.

The FDA contacted the companies that manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula and do not source milk-based ingredients from China.

In addition, the FDA -– in conjunction with state and local officials – continues to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins.

The FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk or milk-derived ingredients from Chinese sources. FDA has recommended that consumers not consume certain products because of possible contamination with melamine. A list of those products is below.

Update on FDA’s Investigation

November 28, 2008: FDA’s ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas. FDA has concluded that levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns. FDA has updated its interim risk assessment, issued in early October, with this information: http://www.cfsan.fda.gov/~dms/melamra4.html.

The FDA has been collecting and analyzing samples of domestically manufactured infant formula for the presence of melamine and melamine-related compounds. To date, FDA tests have found extremely low levels of melamine in one infant formula sample and extremely low levels of cyanuric acid in another. The levels were so low (well below 1 ppm) that they do not pose a health risk to infants: http://www.fda.gov/oc/opacom/hottopics/melamine/testresults.html.

Melamine is not naturally occurring and is not approved to be directly added to food in the United States. However, melamine is approved for use as part of certain food contact substances. Low levels of melamine are present in the environment and trace amounts may occur in certain food commodities as a result of approved uses.
Parents using infant formula should continue using U.S. manufactured infant formula. Switching away from using one of these infant formulas to alternate diets or home-made formulas could result in infants not receiving the complete nutrition required for proper growth and development.

Transcript for FDA’s Media Briefing: FDA’s Updated Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans
November 28, 2008

FDA’s Warnings/Advisories

The FDA is advising consumers not to consume the following products because of possible melamine contamination:

Topaz Wafer Rolls with Chocolate Flavored Cream Filling New!
Topaz Wafer Rolls with Hazelnut Chocolate Flavored Cream Filling New!
Topaz Wafer Rolls with Vanilla Flavored Cream Filling New!
Topaz Wafer Rolls with Mocha Cappuccino Flavored Cream Filling New!
G&J Hot Cocoa Stuffer Item 120144
G&J His and Hers Hot Cocoa Set Item 120129
G&J Cocoa item 120126, sold in 2 flavors: French Vanilla Cocoa and Double Chocolate Cocoa
Wonderfarm “Successful” Assorted Biscuits
Wonderfarm “Royal Flavour” Assorted Biscuits
Wonderfarm “Lovely Melody” Assorted Biscuits
Wonderfarm “Daily Life” Assorted Biscuits
Topaz Hazelnut Wafer Rolls with Hazelnut Chocolate Flavored Creme Filling (photo page)
Sweet Time Christmas Dressy Bear with Chocolate Bar
Fresh and Crispy Jacobina Biscuits
Koala’s March Crème filled Cookies
YILI Brand Sour Milk Drink
YILI Brand Pure Milk Drink
Blue Cat Flavored Drinks
White Rabbit Candies
Mr. Brown Mandehling Blend Instant Coffee (3-in-1)
Mr. Brown Arabica Instant Coffee (3-in-1)
Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
Mr. Brown French Vanilla Instant Coffee (3-in-1)
Mr. Brown Mandheling Blend instant Coffee (2-in-1)
Mr. Brown Milk Tea (3-in-1)
Infant formula manufactured in China

News Updates

November 13, 2008: As part of its ongoing strategy to address the present problem with melamine contamination of consumer products exported from the People’s Republic of China, FDA has expanded its import controls on Chinese dairy products, and food and feed products manufactured in China that contain dairy ingredients. Since Oct. 10, 2008, FDA has had an import alert in place for specific products found contaminated with melamine and melamine-related compounds. FDA has collected additional information on the scope of the melamine contamination problem in China, and determined a countrywide import alert is warranted.

This action will help ensure that only Chinese dairy products and food and feed products manufactured in China that contain dairy ingredients are not contaminated with melamine and melamine-related compounds reach U.S. consumers. No adverse health effects have been reported in the United States from contamination with melamine of dairy products or dairy containing products. But melamine is not approved for direct addition to human or animal foods and no manufacturer is allowed to deliberately add it to any food for U.S. consumers.

As part of ongoing activities, FDA will also examine a range of protein-containing products beyond just dairy and dairy-containing products for contamination with melamine and melamine-related compounds. FDA will continue to take appropriate regulatory action if these efforts uncover additional contamination.

FDA Detects Melamine Contamination in Flavored Drink (October 6, 2008)
FDA Updates Health Information Advisory on Melamine Contamination (Sept 26, 2008)
FDA Updates Health Information Advisory on Melamine Contamination (Sept 23, 2008)
FDA Updates Health Information Advisory on Melamine Contamination (Sept.20, 2008)
FDA Issues Health Information Advisory on Infant Formula (Sept. 12, 2008)

Company Recalls

National Brands Inc. Issues a Nationwide Recall of Topaz brand Wafer Rolls Because of Possible Health Risks New!
Dorsey Marketing Inc. Voluntarily Recalls Three G&J Gourmet Market Cocoa Products: 120126, 120129, 120144 (Dec. 19, 2008)
Interfood Shareholding Company Issues a Nationwide recall of Wonderfarm Brand Biscuits Because of Possible Health Risk (Dec. 9, 2008)
Walgreens Recalls 173 Teddy Bears With Chocolate Bars Sold Since Late September 2008 (Dec. 5, 2008)
Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (Oct. 29, 2008)
Lotte USA, Inc. Initiates Nationwide Recall of Koala’s March Crème filled Cookies (Oct. 17, 2008)
HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (Oct. 10, 2008)
Tristar Food Wholesale, Inc. Issues a Nationwide Recall of Blue Cat Flavored Drink Because of Possible Health Risk (Oct. 3, 2008)
Mr. Brown 3-In-1 & and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (Oct. 1, 2008)
QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (Sept. 26, 2008)

FDA’s Testing Methods

The FDA Field laboratories are using LC-MS/MS methods that are capable of determining melamine and cyanuric acid at levels of 0.25 ppm in powdered infant formula and other dairy-containing food products or ingredients. These and a GC/MS method for melamine and its analogues are:
Melamine Methodology
- Determination of Melamine and Cyanuric Acid Residues in Infant Formula using LC-MS/MS
- Interim Method for Determination of Melamine and Cyanuric Acid Residues in Foods using LC-MS/MS
- GC/MS method for melamine and analogues

FDA is an agency within the Department of Health and Human Services in the USA and consists of nine centers/offices, which are listed below.

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

Center for Drug Evaluation and Research (CDER)

Center for Food Safety and Applied Nutrition (CFSAN)

Center for Veterinary Medicine (CVM)

National Center for Toxicological Research (NCTR)

Office of Chief Counsel

Office of the Commissioner (OC)

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Bernand Simanjuntak — Fri, 03 Apr 2009 13:59:05 +0000

FDA Approves Drug for an Advanced Form of Kidney Cancer

Bernand Simanjuntak — Tue, 31 Mar 2009 11:40:19 +0000

The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.

Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body.

“Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib,” said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing.”

Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).

While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.

A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.

The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.

Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.

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The Beauty of Tobe Lake, North Sumatra, Indonesia

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