Author Archives: Kimberly Crocker

FDA Recalls: Harry & David Coffee, Vitamins. NEW Gastro Vaccine

FDA News Digest

April 7, 2008

_____________________________________

IN THIS WEEK’S ISSUE

»  News

    — FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus

    — Federal Agents Seize More Than $1.3 Million of Illegal Dietary Supplements

»  Safety Alerts/Recalls

n Harry and David Chocolate Covered Select Blend Espresso Beans

n HC Fresh Frozen Salted Croaker

n Malt-O-Meal brand and other private labels

_______________________________________

NEWS

 

FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus

FDA has approved Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid given in a two-dose series to infants from 6 to 24 weeks of age. Rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each year. About 55,000 to 70,000 of those require hospitalization, and between 20 and 60 deaths are attributed to it.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01814.html 

 

Illegal Dietary Supplements Marketed for use by Body Builders.

Federal Agents Seize More Than $1.3 Million 

At FDA‘s request, U.S.  marshals have seized more than $1.3 million of dietary supplements from Michigan-based LG Sciences, LLC. These products — marketed and distributed online and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL” –contain unapproved food additives or ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01815.html

   

 

SAFETY ALERTS/RECALLS

Food Recalls:

›  Harry and David Chocolate Covered Select Blend Espresso Beans, 8-oz. size

Reason for recall: milk component not declared on package

http://www.fda.gov/oc/po/firmrecalls/harrydavid04_08.html

 

›  HC Fresh Frozen Salted Croaker (distributed in New York , New Jersey , Pennsylvania , Illinois and Texas)

Reason for recall: possible Clostridium botulinum contamination

http://www.fda.gov/oc/po/firmrecalls/grandsupercenter04_08.html

 

›  Unsweetened Puffed Rice and unsweetened Puffed Wheat, marketed under the Malt-O-Meal brand and other private labels, with “Best If Used By” dates between April 8, 2008 (coded as “APR0808”), and March 18, 2009 (coded as “MAR1809”)

Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/maltomeal04_08.html

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

FDA Warning: Total Body Formula, Yogurt, ED Vitamins

FDA News Digest

March 31, 2008

_____________________________________

IN THIS WEEK’S ISSUE

› FDA is advising consumers not to buy or use “Blue Steel” or “Hero” products, marketed as dietary supplements throughout the United States, because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect blood pressure level. They are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They are labeled as dietary supplements but do not qualify as such because they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in the ED drug Viagra.  

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01809.html

› FDA also is advising consumers not to buy or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html 

Food Recalls:

› Honduran Cantaloupes grown by Agropecuaria Montelibano

Reason for recall: Salmonella contamination

http://www.fda.gov/oc/opacom/hottopics/cantaloupe.html

› Certain batches of Stonyfield Organic Fat Free Blueberry Yogurt, 6-oz. cups

Reason for recall: reported plastic or glass fragments in product

http://www.fda.gov/oc/po/firmrecalls/stonyfield03_08.html

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

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Recommendations Made on Devices That Treat Blocked Heart Arteries

FDA has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, which are devices used to treat blocked heart arteries. FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines outline the agency’s recommendations for providing data to better address the clot issue and other potential safety concerns.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01810.html

25 Drugs, Biologics Identified for Safety Plan Requirements

FDA has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS). FDA can require manufacturers to submit a REMS when a drug first comes on the market or later if FDA becomes aware of new safety data about the drug. Manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01811.html 

FDA Seeks Civil Penalties from California  Maker of Hearing Aids

FDA is seeking a $2.2 million penalty against  California hearing aid manufacturer Advanced Bionics, LLC, for violations of federal law, including manufacturing standards violations and the failure to notify the agency of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks. The hearing aids pose a risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01813.html 

To view an archive of recent FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html._____________________________________________

 

CONSUMER HEALTH INFORMATION

Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week:

 

› Taking a Close Look at Ultrasound

http://www.fda.gov/consumer/updates/ultrasound032408.html

› Avoid Fetal “Keepsake” Images, Heartbeat Monitors

http://www.fda.gov/consumer/updates/keepsakevideo032408.html  

To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html

Tea’s Combat: Weightloss, Anxiety, Cholesterol, High bp

 “Kava kava Tea has been used to treat anxiety/nervous disorders, migraines, hyperactivity in children, insomnia, menstrual cramps, UTI and bladder problems.  Kava was used by the Germans in the 1890s for pharmaceuticals relating to blood pressure; before then, it was utilized by the Polynesians”, based on collected research at A 2 Z Health, Beauty and Fitness.

Today, Kava is used as a non-addictive way to sooth nerves and relax. In , small recommended doses, no side effects have been found for Kava. However, large dosages of Kava can have a sedative effect, which means that one should avoid alcohol, driving, and operating heavy machinery when taking heavy amounts. Talk to your doctor before consuming Kava tea if you have liver disease.

The “kava” lactones, which are the plant chemicals that produce the desired effects, have been studied in the use of relaxing stiff muscles by blocking signals in the user’s nerves.”

Additional safety studies have been done on Kava.  Negative research has been denounced by Polynesian countries who have used  the plant’s health benefit’s for 3000 years.  Leading others to put into question how the plant is processed and sold  in such countries as Germany and Switzerland.  It should also be noted that the Polynesian lifestyle has been recognized for their longevity, to which Kava has been a contributing factor.

Black Tea  is grown from a tree in higher elevations of China, India, Japan, Sri Lanka. The healing benefits of  black tea has been used throughout history for medicinal purposes. It helps relieve diarrhea, lowers cholesterol levels and helps prevent tooth decay. The tea has a therapeutic effect on gastric and intestinal illnesses because of its tannins. To get the maximum benefit for diarrhea let the tea steep for a full 15 minutes.

Black teaimproves circulation,  by opening the capillaries and normalizing blood pressure (bp).  Benefits are noticed by simply drinking 2 cups of black tea 2x’s a day for 3 weeks.  Additional benefits are contributed to the theophylline in black tea that helps improve cholesterol levels. It also has been known to expand the airways, improving on easier breathing for asthmatics.  Black tea also helps with preventing tooth decay due to the Fluoride, a trace element found in black tea, which strengthens tooth enamel.

Oolong Tea  is made by allowing the raw leaves to sun-wilted and bruise, which exposes their juices to the air, so the leaves oxidise and start to turn brown like a cut fruit. They oxidise only partially, giving them a rich, floral flavour. The tea is then dried fully; locking in the rich flavors that oolong tea is known to offer. Oolong’s unique drying process creates a tea that has many metabolic stimulating attributes, therefore, it comes in a wide range of tastes and aromas from teas very close in taste to green tea to those very close to black tea.

Health Benefits

Oolong tea burns over 157% more fat than Green Tea and has become the most popular tea designed to accelerate weigh loss!!!  Drinking two cups of Oolong tea every day helps shed stubborn pounds by boosting your metabolism and blocking the fattening effects of carbohydrates.

Large quantities of polyphenol in Oolong tea:

  • • promotes strong, healthy teeth;
    • improves cognitive functioning and mental well-being;
    • preventing eczema, allergies
    • clarifies your skin, giving it a healthy, radiant glow and
    • strengthens your immune system.
  • Studies show in Japan and USA that it may be an effective adjunct to treating Type 2 Diabetes.

Only three teas have been discussed, however, many varieties are known to bring a wide range of health benefits.  So end your day by unwinding with a cup of Chamomile tea. 

By: Kimberly Crocker

Literature Research

  • Safety of Kava
  • Anon. FDA Issues Warning on Kava Suplement. St. Louis Post-Dispatch, March 26, 2002.
  • Anon. Kava Use Not Linked to Liver Damage, Report Says. Vitamin Retailer, April 2002.
  • Anon. NNFA Releases Expert Analysis of Kava Safety. Whole Foods, April 2002.
  • Blumenthal, Mark. The Safety of Kava Questioned. Whole Foods, March 2002.
  • Duke, James A. Dr. Duke’s Essential Herbs. New York: St. Martin’s Paperbacks. 2001.

Bruschetta

Fresh tomato's make this a great summer snack!

Bruschetta (bruu skay ttah), an ideal way to consume the delicious fresh tomato’s off the vine, paired with basil and olive oil!

Can be made on Grill, or in the oven under the  broiler.

 

 

 

  • Baguette 1/2 inched round slices
  • Tomatoes Roma or Cherry ( diced. Season to taste with salt and pepper)
  • 3 Garlic cloves (peeled)
  • 12 Basil leaves shredded
  • Extra Virgin Olive Oil (EVOO)

Place sliced bread rounds directly onto a warm fire on the grill and allow to evenly brown on both sides. Or, place sliced bread rounds onto a cookie sheet and evenly toast both sides under broiler (about 90 seconds per side).

Remove bread from grill or oven.

Take a whole peeled single garlic clove and rub it onto one side of each bread slice.

Arrange bread slices onto a platter and place one spoonful of freshly seasoned diced tomatoes onto each bread slice.

Generously drizzle EVOO over each tomato covered sliced bread

Top off each tomato sliced bread with generous amounts of shredded basil.

Get Creative and add roasted peppers, roasted eggplant or olives to your tomato’s or serve on separate

Tomato's combined with olives

toasted bread drizzled with olive oil.

Feed Your Libido…

The best sex begins with great nutrition, according to international studies. Research on Maca is praised for: energy, strength, stamina, libido and sexual function. Doctors and Dietitians confirm that making certain minerals, vitamins and herbs as a part of your daily diet could add some zing to your step and encourage the Health Benefits of Sex.

Almonds, Basil, Vanilla are said to have a perfumes that entice and stimulate attraction.

Celery contains androsterone, a male hormone.  When men eat the celery, pheromones are released through the sweat glands, which then stimulates the female attraction. 

Dietary Source:  Truffles have the same effect!

Figs are fantastic finger foods to be shared between lovers.  They are high in Potassium, fiber, calcium and are all around heart healthy.

Garlic when crushed, releases an active enzyme called allicin.   Allicinassists in: erections, raises HDL cholesterol and fights off a variety of diseases.  The lack of an erection is typically due to reduced amounts of Nitric Oxide in the body.  Allicin inhibits iNOS (induced nitric oxide synthase) and allows nitric oxide to work better in the body.  Those with ED, may be showing a more serious problem that should be brought to your doctor’s attention.  

Dietary Source: Garlic clove: minced  in a vinaigrette,  tossed with vegetables, or rubbed onto a warm slice of baguette bread.

Maca is an herb/ (root) found in Peru, that has been studied for it’s health benefits. Maca is praised for: energy, strength, stamina, libido and sexual function (proven to correct ED). Similar to graham flavor, maca can be added in cookies, cakes, blender drinks, chips, or taken in a capsule (500mg 3x’s/day).

Potassium assists in the body’s electrolyte balance by pushing out excess sodium from cells. It promotes nerve transmission, muscle and nerve functions and a strong healthy heart. 

Dietary Source: fruits, vegetables and legumes.

Vitamin B.

  • Increase mood stability
  • Creates energy reduces headaches, (B-2)
  • Increase blood circulation and is a vessel dilator (B-3).
  • Improves fertility and promotes heart health, (B-12)
  • Reduce depression and stress (B-5 and B-7),
  • Reduces weakness, numbness, tingling in arms, improves on diabetes (B-6)

Dietary Source:  Fortified Cereal, Garbanzo Beans, Chicken, Banana, liver, meat,  eggs, spinach, tomato, potatoes.

Vitamin E   is an important body lubricant for all organs and muscles. Additionally, it keeps skin, eyes and the heart healthy (increasing HDL cholesterol). 

Dietary Source: Extra Virgin Olive Oil (EVOO), Avocado, Almonds, Olives, Nuts, Seeds

 Zinc plays an important part in the desire to reproduce. Including, organ function, increase of sex hormones (estrogen, androgen’s, testosterone) and sperm production.  

Dietary Source: Oysters, beef, pork, dark meat poultry, lamb, peanuts, legumes, (meat /egg protein enhance zinc). 

Ideal Dinner for Two

Substitutions

  • Alcohol: Sparkling Water with lime slice and after dinner coffee (aphrodisiac)  
  • Vegans: Lobster or Tofu instead of steak
  • Shell Fish: Prosciutto, Olives, Almonds, Bruschetta

AMBIANCE

Cover table with a white table linen and lightly scatter rose petals. Or, be adventurous, use fresh basil leaves and halved almonds, instead.  Place a low lit vanilla candle in center of table.

APPETIZERS: 

  • Begin with 1 of Glass of wine (don’t over do it or the plan will fail!) 
  •  Oyster on half shell (or mussels and claims)
  • Olives.

SALAD: 

  • Red Leaf lettuce,
  • Arugula,
  • Figs chopped
  • Avocado slices
  • Raspberry vinaigrette

DINNER: 

  • 4 ounce fillet Mignon top off with  sauteed onions in EVOO,
  • Mashed Potatoes,
  • Steamed green beans and thinly sliced carrot sticks (or Asparagus). Toss with 1tbsp of EVOO, 1 minced garlic clove and chopped almonds.
  • May serve with multi-grain bread.

DESSERT: 

  • Chocolate cake (made with a small amount of Maca),
  • 1 glass Spumante
  • Strawberries to enhance flavor of wine.

By:  Kimberly Crocker

 Global Literature Research

  3. Lonnerdal B. Dietary factors influencing zinc absorption. J Nutr 2000; 130: 1378 S.