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Experts Debate Benefits And Challenges Of New ATA Guidelines And Differentiated Thyroid Cancer

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New Clinical Guidelines For Thyroid Disease Management

The announcement that new clinical practice guidelines for the diagnosis and treatment of hypothyroidism are published in the current issue of Thyroid was made by The American Thyroid Association (ATA). The Guidelines were developed jointly by the ATA and the American Association of Clinical Endocrinologists (AACE) and will be presented on Sunday, Sept. 23, during the 82nd Annual Meeting of the American Thyroid Association in Québec City, Québec, Canada. Hypothyroidism is caused by an underactive thyroid gland that cannot produce enough thyroid hormone. Symptoms of hypothyroidism are often mild and commonly include dry skin, cold sensitivity, fatigue, sluggishness, muscle cramps, voice changes, and constipation. Environmental iodine deficiency is the most common cause of hypothyroidism on a worldwide basis. However, in areas of iodine sufficiency, such as the United States, the most common cause of hypothyroidism is chronic autoimmune thyroiditis (Hashimoto''s thyroiditis). The Guidelines present 52 evidence-based recommendations developed by a join ATA and AACE task force of experts in thyroidology, led by Jeffrey R. Garber, MD, , president of the American College of Endocrinology (ACE) and Harvard Vanguard Medical Associates'' endocrine division chief. The Guidelines were developed following a rigorous review of relevant medical literature and the current standards of care, and drew upon the task force''s collective knowledge and experience in diagnosing and caring for patients with hypothyroidism. (The task force defined overt hypothyroidism as a Thyroid Stimulating Hormone (TSH) level above 10 mIU/L, and subclinical hypothyroidism as a TSH less than 10 mIU/L, with lower Free Thyroxine (Free T4) levels.)

"The Clinical Practice Guideline for Management of Hypothyroidism'' is based on a comprehensive review and assessment by experts of what has been published about hypothyroidism," said Dr. Garber. "We trust that by providing evidenced-based guidelines for patients with hypothyroidism the quality of care for this common, important and readily treatable condition will improve."

Key recommendations include:

- An endocrinologist should be consulted when children and infants, pregnant patients and women planning conception, those with heart disease, and those with other endocrine diseases such as adrenal and pituitary disorders, are affected.

- Serum TSH is the single best screening test for hypothyroidism. It is not sufficient for assessing hospitalized patients or when central hypothyroidism is present or suspected (central hypothyroidism is due to a decrease in the secretion of TSH from the pituitary gland).

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- Hypothyroidism should be treated with Levothyroxine (T4).

- No clinical data exists to support the effectiveness of over-the-counter products marketed for "thyroid support" or to promote "thyroid health."

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- Levothyroxine (T4) and Levotriiodothyronine (T3) combinations, including desiccated thyroid, should not be used during pregnancy or in those who are planning pregnancy.

- Mild TSH elevations in the elderly may be a normal manifestation of aging and not necessarily indicate hypothyroidism.

Source-Newswise

Red Dye No. 3 Could Be Banned In Coming Weeks—Impacting These Foods

Topline

The Food and Drug Administration is weighing a ban on the artificial food coloring Red No. 3, which has been linked to thyroid cancer in animals and behavioral health issues in children, after years of prodding by parents and health advocates, one state ban and action by dozens of other countries.

Dubble Bubble gum.

Getty Images Key Facts

Jim Jones, the FDA's deputy commissioner for human foods, said late last week he is "hopeful" the agency will act on a petition to ban the use of Red No. 3 in food and ingested drugs in the coming weeks, decades after it was banned in cosmetics and externally applied drugs for its link to thyroid cancer in animals.

Red No. 3 or erythrosine, a color additive made from petroleum, can currently be used in foods in small amounts as approved by the FDA on a per-case basis.

The FDA has been considering the petition to ban the additive since 2022 and, in that time, California became the first state to outlaw the sale of foods with Red No. 3, while lawmakers in 10 other states have introduced legislation to do the same.

Robert F. Kennedy Jr., President-elect Donald Trump's pick for health secretary, has also vowed to crack down on the use of food dyes if he's confirmed, claiming the dyes cause cancer and A.D.H.D. In children.

Red No. 3 is significantly more regulated in other parts of the world, including in the European Union, where it is only authorized for use in cocktail and candied cherries, and in Korea, where the use of most synthetic colors is prohibited in certain foods eaten mostly by children and teenagers.

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What Foods Have Red Dye 3?

Candy, fruit juice and other snack foods are the most common sources of the dye, which is still found in more than 2,800 items on American shelves. Products that have listed red 3 in recent years include some types of Fruit by the Foot, Dubble Bubble chewing gum, Entenmann's Little Bites, Hostess' Ding Dongs, Nestle strawberry milk, Jordan Almonds, Pez hard candies, Peeps marshmallows, Brach's candy corn and some flavors of Ringpop, according to the the Environmental Working Group and the Center for Science in the Public Interest (one of the petitioners looking to ban the dye). Grocery store chains Albertson's, Kroger, Meijer's, Target and Walmart all use Red 3 in some of their house-brand products, and other items like Betty Crocker's loaded mashed potatoes, Vigo saffron yellow rice and Don Pancho green and blue tortilla chips also list the dye as an ingredient.

What Medications Have Red Dye 3?

Some common medicines that contain Red No. 3 include Tylenol PM, gabapentin and doxycycline. Red No. 3 is also an inactive ingredient in the capsule shell of the popular A.D.H.D. Drug Vyvanse.

What Are The Problems With Red No. 3?

Decades-old studies found that Red No. 3 causes cancer in laboratory animals, specifically thyroid cancer in rats, but the FDA has said those studies "have limited relevance to humans" because cancer isn't caused in the same way in both species. There aren't studies that show Red No. 3 causes thyroid cancer in humans. Other research has linked the additive to behavioral health issues, like attention deficit hyperactivity disorder, particularly in children. Clinical trials over the last two decades have shown that children who consumed juices containing food dyes experienced a small but significant increase in hyperactivity, but the link wasn't considered strong enough for the FDA to require warning labels about their potential effects on children. In 2021, California state scientists and researchers from the University of California reviewed dozens of trials and came to a similar conclusion, that food dyes can interfere with normal behavior in some children.

Crucial Quote

"There's a reasonable suspicion that food dyes may be harmful, at least for some kids," Joel Nigg, a professor of psychiatry at Oregon Health and Science University, told The New York Times. "So why expose them to it?"

Big Number

215,780. That's how many pounds of Red No. 3 was used in 2021 by the food and drug industries, according to the FDA.

Surprising Fact

On a body weight basis, children 2 to 5 years old consume about twice as much of the red dye through food as the general population, according to the FDA.

Key Background

The Food and Drug Administration banned red dye No. 3 for use in cosmetics and externally applied drugs in 1990 due to findings from unpublished animal research that linked the chemical to thyroid cancer, but it is still approved for use in food, ingestible drugs and dietary supplements. Any use of the dye has to be approved by the FDA, down to the specific batch added to foods. Companies are only allowed to use the additive from batches of the product that the agency has analyzed a sample of and found that it meets the requirements for safety and purity. Red No. 3 also has to be declared in the ingredient lists on all food labels containing the additive. In 2022, a host of health groups including the Center for Environmental Health, Environmental Defense Fund, Public Health Institute and Healthy Babies Bright Futures filed a petition with the FDA asking it revoke the right to use Red. No 3 in all foods and ingested drugs, calling the additive "unsafe."

Further Reading ForbesHere's Why California May Ban Skittles, Nerds And Other Popular SnacksBy Arianna JohnsonForbesCalifornia Legislator Proposes Banning These Food Dyes In Public Schools Over Alleged ADHD Link—Here's WhyBy Mary Whitfill RoeloffsForbesThe Products Affected By The California Food Additives Ban [Infographic]By Katharina Buchholz

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