FDA Overview: Products with potential Melamine contamination

The Food and Drug Administration (FDA) has stated that there is no known threat of contamination of infant formula manufactured by companies that have met the requirements to sell such products in the United States. However, the following is a list of companies and their products being recalled because of detected melamine contamination:

Lotte USA Inc., of Battle Creek, Mich.

* All flavors of Koala March Cookies. Distributed nationwide and to Canada through wholesale distributors and retail stores. The products are packaged in a plastic overwrap.

Hua Xia Food Trade USA Inc. of Flushing, N.Y.

* YILI Brand Sour Milk Drink. Distributed to New York City through Asian retail grocery stores and packaged in 250 ml flexible paperboard boxes with blue, red and green Chinese writing. There is a picture of an Asian man in a green shirt and white tie.
* YILI Brand Pure Milk Drink. Distributed to New York City through Asian retail grocery stores and packaged in 250 ml flexible paperboard boxes with black, red and white writing in English and Chinese. There is a picture of two cows playing a sport on the face of the box.
Tristar Food Wholesale Co. Inc. of Jersey City, N.J.

* Blue Cat Flavor Drink. Sold nationwide in Asian grocery stores, the product comes in 100 ml plastic bottles with a logo of blue cat on the back of the bottle and the word “blue cat” in Chinese on the front.
QFCO Inc. of Burlingame, Calif.

* White Rabbit Candy. Sold through wholesale distributors to retail stores in California, Georgia, Hawaii, Illinois, Minnesota, New York, Oregon, Texas and Washington.
Sunny Maid Corp. of Monterey Park, Calif.

* Mr. Brown instant coffee and milk tea products. Mr. Brown 3-in-1 and 2-in-1 powdered packets were sold in plastic bags, each containing 30 individual packets. Flavors include Mandheling Blend, Arabica, Blue Mountain Blend, Caramel Macchiato, French Vanilla and Milk Tea.

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

* 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

Consumers should stop using these products and return them to the place of purchase for a refund.

FDA Statement (here)
Melamine Contamination in China (here)

Vaccine Insanity: Caution for Pregnant Women

This abstract suggests that pregnant women need to receive vaccinations during pregnancy. This is advice, really is reckless. Why not talk about reducing environmental hazards, and how to boost one’s natural immunity. We are really meant to interface with our environment without the need of vaccines. Illness and sickness do serve a purpose and as the body heals it becomes stronger and also the immune system is strengthened.

Vaccines for Pertussis and Influenza: Recommendations for Use in Pregnancy.

New Antibiotics and Vaccines in Obstetric Practice

Abstract:
The active immunization of pregnant women during pregnancy to protect them from disease and protect their neonate with passive antibodies is a biologic fact. Fortunately, many infectious diseases occur infrequently due to excellent pediatric vaccine programs. However, most adults and many physicians are unaware of the risks of not administering vaccines especially to pregnant women. Influenza vaccine (trivalent inactivated influenza vaccine) is recommended by (Advisory Committee on Immunization Practices (ACIP) for pregnant women in any trimester of pregnancy and Tetanus, reduced diphtheria, and pertussis (TdaP) vaccine is recommended by the ACIP to be given before pregnancy, during pregnancy, or in the immediate postpartum period. Only 2% of the adult US population is protected against pertussis and it is estimated that only 25% of pregnant women receive influenza vaccine during the influenza season. This chapter discusses trivalent inactivated influenza vaccine and TdaP use during pregnancy, the diseases they prevent, and the benefit to the neonate.

Influenza Vaccine in Infants Younger Than 6 Months of Age

This study, see below, assesses the need for infants less than 6 months old to receive influenza vaccine. The study is funded, designed and carried out by a vaccine manufacturer. Bias could be construed in the entire study.

There is on going discussion of how allergic reactions continue to rise in the population. Overuse of antibiotics is seen as a contributing factor (mind you, they were once hailed as ‘wonder drugs’), could the indiscriminate use of vaccines also be a contributing factor? The entire human race has lived without the need of vaccines at birth and throughout life at least since recorded history. Young children used to get sick and there is evidence it made them healthier. Mumps, measles, chicken pox were for the most part lived through. The body developed immunity against the ailment and life went on. Now, it is seen as a constant source of fear and on going threat. Why?
Here is the ‘study’ why healthy infants need influenza vaccine:

Safety and Tolerability of Cold-Adapted Influenza Vaccine, Trivalent, in Infants Younger Than 6 Months of Age

Timo Vesikari, MDa, Aino Karvonen, MDa, Helen M. Smith, BScb, Andrew Dunning, PhDc, Ahmad Razmpour, PhDc, Melanie K. Saville, MB, BSb, William C. Gruber, MDc and Bruce D. Forrest, MDc a Vaccine Research Center, University of Tampere Medical School, Tampere, Finland
b Wyeth Vaccines Research, Taplow, United Kingdom
c Wyeth Vaccines Research, Pearl River, New York

OBJECTIVE. Young children are at high risk for influenza-related complications. Vaccination of close household contacts is recommended to provide indirect protection to children <6 months of age. Studies have shown that live, cold-adapted influenza vaccine, trivalent, is efficacious in children. To assess the risks associated with inadvertent exposure of infants to vaccine viruses from vaccinated contacts, this study was designed to evaluate the safety and tolerability of cold-adapted influenza vaccine, trivalent, administered intranasally to healthy children 6 to <24 weeks of age.

METHODS. Healthy infants aged 6 to <16 weeks and 16 to <24 weeks, respectively, were randomly assigned to receive 2 doses of influenza vaccine, or placebo intranasally 35 ± 7 days apart. Reactogenicity events were monitored for 11 days after each dose. Other adverse events were monitored through 28 to 35 days after dose 2.

RESULTS. Of the infants aged 6 to <16 weeks, 31 received influenza vaccine and 28 received placebo, and of those aged 16 to <24 weeks, 30 received influenza vaccine and 31 received placebo. In the 6- to <16-week cohort, more influenza vaccine, recipients experienced irritability (66.7% vs 35.7%) and runny nose or nasal congestion (63.3% vs 33.3%) after dose 1 but not dose 2. There were no significant increases in any other reactogenicity events or adverse events in the vaccine recipients compared with the placebo group.

CONCLUSIONS. Although there was an increase in mild reactogenicity events in children 6 to <16 weeks of age, cold-adapted influenza vaccine, trivalent, was generally well tolerated in infants 6 to <24 weeks of age. These findings support further evaluation of cold-adapted influenza vaccine, trivalent, in infants <6 months of age.

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