Durk Pearson and Sandy Shaw sue the FDA for qualified Health Claims 1999

At the behest of Durk Pearson and Sandy Shaw, Emord & Associates sued the FDA in the 1990s for refusing Pearson and Shaw’s request to authorize four specific health claims for dietary supplements.  Pearson and Shaw sought agency approval of claims associating antioxidant vitamins with cancer risk reduction; omega-3 fatty acids with vascular disease risk … Continue reading "Durk Pearson and Sandy Shaw sue the FDA for qualified Health Claims 1999"

At the behest of Durk Pearson and Sandy Shaw, Emord & Associates sued the FDA in the 1990s for refusing Pearson and Shaw’s request to authorize four specific health claims for dietary supplements.  Pearson and Shaw sought agency approval of claims associating antioxidant vitamins with cancer risk reduction; omega-3 fatty acids with vascular disease risk reduction; folic acid with neural tube defect risk reduction; and fiber with colorectal cancer risk reduction.  In particular, Pearson and Shaw argued that if FDA did not approve the claims under its “significant scientific agreement” standard, it nevertheless had to allow them to comply with the First Amendment, resorting to a succinct disclaimer to communicate its doubts about the science supporting the claims.  The FDA refused to allow any of the claims or rely on claim qualification as a less speech restrictive alternative to outright suppression, and our firm, as Pearson and Shaw’s counsel, sued the agency.  That suit resulted in a landmark victory over the FDA before the United States Court of Appeals for the D.C. Circuit in Pearson v. Shalala (1999).

In Pearson v. Shalala, the D.C. Circuit agreed with Pearson and Shaw that FDA was obligated by the First Amendment to favor disclosure with accurate, succinct and reasonable disclaimers over suppression and to rely on claim qualification rather than outright suppression.  That then ultimately led to the FDA’s qualified claim regime, but only after Emord & Associates defeated the FDA several more times in federal court for refusing to abide by the Pearson v. Shalala decision.

Here are the decisions in which the firm defeated the FDA:

Pearson v. Shalala
Pearson v. Shalala, en banc
Pearson v. Shalala II
Pearson v. Thompson
Whitaker v. Thompson I
Whitaker v. Thompson II
Whitaker v. Thompson III

Alliance for Natural Health US v. Sebelius, et al.

Emord & Associates has petitioned the FDA for approximately 100 qualified health claims.  The following claims have been allowed by FDA either directly or after the firm has defeated the agency in federal court:

Antioxidant Vitamins C and E and Reduction in the Risk of Site-Specific Cancers

  • Vitamin C

Gastric (Stomach) Cancer:  “One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer. Based on these studies, FDA concludes that it is highly uncertain that vitamin C supplements reduce the risk of gastric cancer.”

  • Vitamin E

Bladder Cancer:  “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.”

Colorectal Cancer:  “Two weak studies and one study with inconsistent results suggest that vitamin E supplements may reduce the risk of colorectal cancer. However, another limited study showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of colorectal cancer.”

Renal Cell Cancer:  “One weak and limited study suggests that vitamin E supplements may reduce the risk of renal cell cancer. FDA concludes that it is highly uncertain that vitamin E supplements reduce the risk of renal cell cancer.”

Antioxidant Vitamins and Risk of Certain Cancers

  • “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”
  • “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA does not endorse this claim because this evidence is limited and not conclusive.”
  • “FDA has determined that although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive.”

B Vitamins and Vascular Disease

  • “As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular disease.  FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.”

Calcium and Colon/Rectal Cancers and Recurrent Colon Polyps

  • “Some evidence suggests that calcium supplements may reduce the risk of colon/rectal cancer, however, FDA has determined that this evidence is limited and not conclusive.”
  • “Very limited and preliminary evidence suggests that calcium supplements may reduce the risk of colon/rectal polyps. FDA concludes that there is little scientific evidence to support this claim.”

Calcium and Hypertension; Pregnancy Induced Hypertension; and Preeclampsia

  • “Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension. However, FDA has determined that the evidence is inconsistent and not conclusive.”
  • “Four studies, including a large clinical trial, do not show that calcium supplements reduce the risk of pregnancy-induced hypertension during pregnancy. However, three other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of pregnancy-induced hypertension.”
  • “Three studies, including a large clinical trial, do not show that calcium supplements reduce the risk of preeclampsia during pregnancy. However, two other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of preeclampsia.”

Chromium Picolinate and Insulin Resistance

  • “One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.”

Folic Acid and Neural Tube Defects (and here)

  • “0.8 mg folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form. FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects.”
  • “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. The Institute of Medicine of the National Academy of Sciences recommends that women capable of becoming pregnant consume 400 mcg folate daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet.”
  • “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. The scientific evidence that 400 mcg folic acid daily reduces the risk of such defects is stronger than the evidence for the effectiveness of lower amounts. This is because most such tests have not looked at amounts less than 400 mcg folic acid daily.”
  • “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. Women capable of becoming pregnant should take 400 mcg folate/day from fortified foods and/or a supplement, in addition to food folate from a varied diet. It is not known whether the same level of protection can be achieved by using only food that is naturally rich in folate. Neither is it known whether lower intakes would be protective or whether there is a threshold below which no protection occurs.”
  • “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. Women capable of becoming pregnant should take 400 mcg of folate per day from a supplement or fortified foods and consume food folate from a varied diet. It is not known whether the same level of protection can be achieved by using lower amounts.”

Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease

  • “It is known that diets low in saturated fat and cholesterol may reduce the risk of heart disease. The scientific evidence about whether folic acid, vitamin B6 and vitamin B12 may also reduce the risk of heart disease and other vascular diseases is suggestive, but not conclusive. Studies in the general population have generally found that these vitamins lower homocysteine, an amino acid found in the blood. It is not known whether elevated levels of homocysteine may cause vascular disease or whether high homocysteine levels are caused by other factors. Studies that will directly evaluate whether reducing homocysteine may also reduce the risk of vascular disease are not yet complete.”

Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease

  • “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.  One serving of [Name of the food] provides [  ] gram of EPA and DHA omega-3 fatty acids.  [See nutrition information for total fat, saturated fat, and cholesterol content.]”

Phosphatidylserine and Cognitive Dysfunction and Dementia (and here and here)

  • Dementia:  “Consumption of phosphatidylserine may reduce the risk of dementia in the elderly.  Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”
  • Cognitive dysfunction:  “Consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”

Selenium and Reduced Risk of Site-specific Cancers

  • Bladder Cancer:  “One study suggests that selenium intake may reduce the risk of bladder cancer in women.  However, one smaller study showed no reduction in risk.  Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women.”  
  • Prostate Cancer:  “Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk.  Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”
  • Thyroid Cancer:  “One weak, small study suggests that selenium intake may reduce the risk of thyroid cancer. Based on this study, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of thyroid cancer.”

Tomatoes and Prostate, Ovarian, Gastric and Pancreatic Cancers

  • Prostate Cancer:  “Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.”
  • Gastric Cancer:  “Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer.”
  • Ovarian Cancer:  “One study suggests that consumption of tomato sauce two times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer.”
  • Pancreatic Cancer:  “One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk.

Information sourced directly from Emord and Associates.

Emord & Associates has extensive experience in prosecuting health claim petitions before the FDA.  Indeed, the qualified health claim regime at FDA is a result of the landmark decision reached in Pearson v. Shalala (1999) in which the firm served as lead counsel for the victorious plaintiffs. http://emord.com/firm-profile/health-claims/

Lifeguarding Women’s Health

Staying on top of all the latest healthy foods and diets is exhausting, and knowing all the latest news about vitamins is no different. Almost everyone can benefit from taking a supplement with calcium because most people don’t get as much as they need through their diets — 1,000 mg a day for adults, increasing to 1,200 mg after age 50.

What Consumers Need to Know About Vitamins

From “Everything You Need to Know About Vitamins” in Everyday Health:

Paul Thomas, EdD, RD, scientific consultant with the National Institutes of Health Office of Dietary Supplements, notes that some vitamins become especially important at certain times in a person’s life. For example, pregnant women or women who may become pregnant should be certain to get enough folate, or folic acid, a B-complex vitamin — 600 units a day, rather than 400. And as you age, you should probably take a daily supplement to get additional B12, he suggests.
“You don’t have to become an expert or learn all the intricacies of all the vitamins — because you can’t,” adds Dr. Thomas. There’s simply too much information to try to remember. What you need to do is eat a healthy diet, selecting recommended foods based on the USDA guidelines. Because few of us consistently eat a well-balanced diet, Thomas says taking an over-the-counter multivitamin, even a store brand, is a good idea. “It’s sort of like an insurance policy that covers all your bases,” he explains.

Insuring the Right Balance in Your Diet

Insuring your nutrition with a multivitamin could possibly be your summer’s lifeguard. We cannot possibly intake the proper amount of nutrients and vitamins from our daily diets so we need multivitamins to help protect our body, like a lifeguard protects and watches over you when you’re swimming.

Multivitamin One-Per-Meal LifeGuard might help when you’re drowningLifeGuard Daily Antioxidant Supplement in a bad diet. It was formulated by two of the top nutritional scientists in the world who wrote a bestselling book in 1978 about life extension. LifeGuard is packed full of 27 essential vitamins and nutrients that may strengthen the immune system and protect your body from free radical damage.

 

 

 

 

Life Priority, established in 1994, offers supplements that are scientifically-formulated, results-oriented, and GRAS (Generally Recognized As Safe) and are manufactured at USDA and FDA inspected facilities.
*The products and statements made about specific products on this web site have not been evaluated by the United States Food and Drug Administration (FDA) and are not intended to diagnose, treat, cure or prevent disease. All information provided on this web site or any information contained on or in any product label or packaging is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional. You should not use the information on this web site for diagnosis or treatment of any health problem. Always consult with a healthcare professional before starting any new vitamins, supplements, diet, or exercise program, before taking any medication, or if you have or suspect you might have a health problem.
*Any testimonials on this web site are based on individual results and do not constitute a guarantee that you will achieve the same results.

Brush Up On Healthy Habits!

Did you know that your oral health can offer clues about your overall health?

Brush Up On Healthy Habits!

Did you know that your oral health can offer clues about your overall health — or that problems in your mouth can affect the rest of your body? Understand the intimate connection between oral health and overall health and what you can do to protect yourself.

What’s the connection between oral health and overall health?[1]

Like many areas of the body, your mouth is teeming with bacteria — most of them harmless. Normally the body’s natural defenses and good oral health care, such as daily brushing and flossing, can keep these bacteria under control. However, without proper oral hygiene, bacteria can reach levels that might lead to oral infections, such as tooth decay and gum disease.

In addition, certain medications — such as decongestants, antihistamines, painkillers and diuretics — can reduce saliva flow. Saliva washes away food and neutralizes acids produced by bacteria in the mouth, helping to protect you from microbial invasion or overgrowth that might lead to disease.

Studies also suggest that oral bacteria and the inflammation associated with periodontitis — a severe form of gum disease — might play a role in some diseases. In addition, certain diseases, such as diabetes and HIV/AIDS, can lower the body’s resistance to infection, making oral health problems more severe.

What conditions may be linked to oral health?

Your oral health might affect, be affected by, or contribute to various diseases and conditions, including:

 Endocarditis. Endocarditis is an infection of the inner lining of your heart (endocardium). Endocarditis typically occurs when bacteria or other germs from another part of your body, such as your mouth, spread through your bloodstream and attach to damaged areas in your heart.

Cardiovascular disease. Some research suggests that heart disease, clogged arteries and stroke might be linked to the inflammation and infections that oral bacteria can cause.

Pregnancy and birth. Periodontitis has been linked to premature birth and low birth weight.

Diabetes. Diabetes reduces the body’s resistance to infection — putting the gums at risk. Gum disease appears to be more frequent and severe among people who have diabetes. Research shows that people who have gum disease have a harder time controlling their blood sugar levels.

HIV/AIDS. Oral problems, such as painful mucosal lesions, are common in people who have HIV/AIDS.

Osteoporosis. Osteoporosis — which causes bones to become weak and brittle — might be linked with periodontal bone loss and tooth loss.

Alzheimer’s disease. Tooth loss before age 35 might be a risk factor for Alzheimer’s disease.

Other conditions. Other conditions that might be linked to oral health include Sjogren’s syndrome — an immune system disorder that causes dry mouth — and eating disorders.

Life Priority’s Suggestions to Improve Oral Health

  • Brush your teeth at least twice a day (after breakfast and before bed).
  • We suggest a NON-Fluoride toothpaste (Tom’s Fluoride-Free Toothpaste)
  • Floss daily. I prefer to use a floss with wax, coupled with The Doctor’s BrushPicks.
  • Eat a healthy diet and limit between-meal snacks. Eat lots of fruits and vegetables and fresh juicing.
  • Take your supplements to insure a healthy foundation, specifically 3 Way Calcium™ for stronger and healthier teeth.

3 Way Calcium™ helps to maintain healthy teeth.  When calcium levels are low, the jawbone surrenders the mineral to other areas of the body in need. As the jaw weakens, teeth loosen, creating gaps susceptible to bacteria that can cause infection, inflammation and bleeding.

  • Replace your toothbrush every three to four months or sooner if bristles are frayed. Buy a quality American-made product.
  • Schedule regular dental checkups at least every 6 months. Contact your dentist as soon as an oral health problem arises. Please notify your dentist if you’re taking any medications.

Taking care of your oral health is an investment in your overall health.

Information sourced from http://www.mayoclinic.com/health/dental/DE00001

Education is the Key to Good Health!

Please consider using Life Priority high quality supplements as a nutritional compliment to your diet!

www.lifepriority.com    800.787.5438

[1] www.mayoclinic.org/dental/ART-20047475?p=1

Life Priority, established in 1994, offers supplements that are scientifically-formulated, results-oriented, and GRAS (Generally Recognized As Safe) and are manufactured at USDA and FDA inspected facilities.
*The products and statements made about specific products on this web site have not been evaluated by the United States Food and Drug Administration (FDA) and are not intended to diagnose, treat, cure or prevent disease. All information provided on this web site or any information contained on or in any product label or packaging is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional. You should not use the information on this web site for diagnosis or treatment of any health problem. Always consult with a healthcare professional before starting any new vitamins, supplements, diet, or exercise program, before taking any medication, or if you have or suspect you might have a health problem.
*Any testimonials on this web site are based on individual results and do not constitute a guarantee that you will achieve the same results.

Brush Up On Healthy Habits!

Our parents always asked us if we had brushed our teeth when we were younger, and they may have been on to something with their persistence. Other than the obvious benefits of healthy teeth like having a nice smile and a clean mouth, brushing your teeth also helps the rest of your body. With so many germs on our hands and the food we eat, a clean mouth is the first line of defense to keep our body healthy and protected.

How are oral health and overall health connected?

Brushing TeethBacteria can be found almost anywhere on or within our body, but most bacteria are harmless. Simple prevention methods like washing your hands, bathing and practicing good oral hygiene can prevent serious problems and health risk from occurring. However, without proper hygiene, especially brushing and flossing, bacteria can reach dangerous levels. Oral infections, such as tooth decay and gum disease can be particularly crippling due to their delicate nature. Practicing good oral hygiene is a must.

Improper dental care can lead to larger health issues that may include cardiovascular disease, diabetes, endocarditis, and various other conditions.  Also, some medications like painkillers and decongestants may reduce your natural saliva flow. Saliva is important because it rinses/washes away food and helps break down acids from bacteria in the mouth saliva washes away food and neutralizes acids produced by bacteria in the mouth. Thus, saliva is crucial in protecting you from an overgrowth of bacteria in your mouth that could lead to more harmful health issues.

Life Priority’s Suggestions to Improve Oral Health

  • Brush your teeth at least twice a day (after breakfast and before bed)
  • We suggest a NON-Fluoride toothpaste, like Tom’s Fluoride-Free Toothpaste
  • Floss daily. I prefer to use a floss with wax, coupled with The Doctor’s BrushPicks
  • Eat a healthy diet and limit between-meal snacks. Eat lots of fruits, vegetables and fresh juice
  • Take your supplements to insure a healthy foundation, specifically Calcium for healthier teeth

Calcium helps to maintain healthy teeth.  When calcium levels are low, the jawbone surrenders the mineral to other areas of the body in need. As the jaw weakens, teeth loosen, creating gaps susceptible to bacteria that can cause infection, inflammation and bleeding.

  • Replace your toothbrush every three to four months or sooner if bristles are frayed. I would suggest Oral-B because it’s a quality American-made product.
  • Schedule regular dental checkups at least every 6 months. Contact your dentist as soon as an oral health problem arises. Please notify your dentist if you’re taking any medications.

Need a calcium boost?

Life Priority's 3-Way Calcium Complex Supplement

If you need a little help getting enough calcium in our diet, our  3-Way Calcium™ supplement offers three different sources of Calcium, tricalcium phosphate, calcium citrate, calcium ascorbate, calcium borate for high bioavailability and absorption, so they reach your bones quicker and are utilized more effectively. 3-Way Calcium™ also includes several nutrient co-factors which help the body use calcium ABCD. Four capsules of Durk & Sandy’s 3-Way Calcium™ contain 1,000 mg of calcium, the same amount in 20 ounces of milk and 800 iu of Vitamin D, or the amount in 1/2 gallon of fortified milk.