Recently the FDA issued a statement of concern regarding the unregulated nature of these products and on August 6, 2025 sent letters to DTE manufacturers announcing their intention to ban DTE from the marketplace. In this communication, they suggested that patients work with their physicians to transition to FDA-approved products over a 12 month period. The ATA is aware that some patients taking DTE may not wish to transition to an alternative thyroid hormone replacement.

The FDA is now proposing that manufacturers of DTE submit an application through a regulatory pathway outlined under section 505 of the Federal Food, Drug, and Cosmetic (FD&C) Act, which applies to biologic products. The ATA supports evidence-based patient guidance, supported by high quality clinical research on the safety and efficacy of thyroid hormone replacement products. The ATA also supports regulations that ensure medication purity and consistency. The FDA’s identification of significant violations of current good manufacturing practice for DTE products is alarming. However, removal of the DTE from the marketplace during a potentially lengthy biologics license application would leave patients without access to DTE for an unknown period of time.

The ATA supports the principle of patient access to all safe and effective therapies for hypothyroidism. A regulatory approach that ensures the highest standards for DTE safety and reliability will ultimately benefit patients. The ATA is committed to working with the FDA, clinicians providing care for patients with hypothyroidism, patients, patient support organizations, and industry partners to ensure that safe and effective personalized hypothyroidism treatment remains available to all. The ATA is the leading professional medical society focused on thyroid diseases with recognized expertise in their treatment. The expertise of ATA was highlighted by the FDA in their recent statement. ATA’s vision, “Optimal Thyroid Health for All,” guides the organization in all areas, especially in the production of resources for clinicians and patients which are available through its website.

About the American Thyroid Association^® (ATA)
The ATA^® is dedicated to transforming thyroid care through clinical excellence, education, scientific discovery and advocacy in a collaborative and diverse community. ATA^® is an international professional medical society with over 1,700 members from seventy countries around the world.

The ATA^® promotes thyroid awareness and information through its online Clinical Thyroidology^® for the Public (distributed free of charge to over 12,000 patients and public subscribers) and extensive, authoritative explanations of thyroid disease and thyroid cancer in both English and Spanish. The ATA^® website www.thyroid.org serves as a trusted clinical resource for patients and the public looking for reliable thyroid-related information.

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AMERICAN THYROID ASSOCIATION Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer (Thyroid, 2016) address this issue with four important recommendations/suggestions: (1) FNA is not required for thyroid nodules less than 1 cm that appear to be confined to the thyroid; (2) active surveillance can be considered as an alternative to immediate surgery in patients with very low risk tumors, (3) restrict surgery (currently the Standard of Care) to lobectomy and avoid radioactive iodine in those with low risk features; and (4) conduct further research (preferably in the setting of IRB-approved clinical trials) to define the role of active surveillance instead of surgery for patients with low risk tumors (as is currently done for men with indolent prostate cancer), and the role of other tools, such as molecular markers and imaging, in better cancer diagnosis and prognosis.

While additional scientific and medical knowledge is required, the AMERICAN THYROID ASSOCIATION advises that these recommended clinical approaches in the interim may safely and effectively address the recent increased incidence of thyroid cancer.

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Ingestion of greater than 1,100 mcg of iodine per day (Tolerable Upper Limits for iodine) (1) is not recommended and may cause thyroid dysfunction. During pregnancy and lactation, the recommendations for the upper limit vary and range from 500-1,100 mcg of iodine daily (2). In particular, infants, the elderly, pregnant and lactating women, and individuals with preexisting thyroid disease are susceptible to adverse effects of excess iodine intake and exposure (5). The public is advised that many iodine, potassium iodide, and kelp supplements contain iodine in amounts that are up to several thousand times higher than the daily Tolerable Upper Limits for iodine. The American Thyroid Association (ATA) advises against the ingestion of iodine and kelp supplements containing in excess of 500 mcg iodine daily for children and adults and during pregnancy and lactation. Chronic iodine intake in amounts greater than the Tolerable Upper Limits should be closely monitored by a physician. There is only equivocal data supporting the benefit of iodine at higher doses than these, including a possible benefit for patients with fibrocystic breast disease (6). There is no known thyroid benefit of routine daily iodine doses in excess of the U.S. RDA.

There are a limited number of medical conditions in which the short-term use of high amounts of iodine is indicated. Exceptions for the recommendations to not exceed the Tolerable Upper Limits include closely-monitored patients prescribed Lugol’s solution or SSKI (saturated solution of potassium iodide) in their treatment of severe hyperthyroidism, such as thyroid storm and prior to surgery in patients with Graves’ disease, and individuals in the vicinity of a nuclear power plant who are recommended to take KI in the event of a nuclear accident. SSKI is not indicated nor recommended in individuals with thyroid nodules. Finally, patients receiving the large amounts of iodine in iodinated contrast dyes, as required for radiologic studies, should be monitored for iodine-induced thyroid dysfunction if risk factors are present.

Key points:

– Adequate iodine intake is required for normal thyroid function

– The recommended iodine intake in non-pregnant adults is 150 mcg daily

– Higher iodine intakes are recommended in pregnancy and lactation

– Given a Tolerable Upper Limit of 1100 mcg iodine daily, ingestion of an iodine or kelp supplement containing in excess of 500 mcg iodine daily should not be done

– Certain exceptions to these recommendations include those for specific medical conditions; such individuals should be closely monitored for thyroid dysfunction

References:

1. Food and Nutrition Board, Institute of Medicine. Dietary reference intakes. Washington, D.C.: National Academy Press; 2006.

2. De Groot L, Abalovich M, Alexander EK, Amino N, Barbour L, Cobin RH, Eastman CJ, Lazarus JH, Luton D, Mandel SJ, Mestman J, Rovet J, Sullivan S. Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2012;97:2543-65.

3. Leung AM, Pearce EN, Braverman LE. Iodine content of prenatal multivitamins in the united states. N Engl J Med 2009;360:939-40.

4. Stagnaro-Green, A, Abalovich, M, Alexander, E, Azizi, F, Mestman, J, Negro, R, Nixon, A, Pearce, EN, Soldin, OP, Sullivan, S, Wiersinga, W, American Thyroid Association Taskforce on Thyroid Disease During Pregnancy and Postpartum. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid 2011;21:1081-1125.

5. Leung AM and Braverman LE. Iodine-induced thyroid dysfunction. Curr Opin Endocrinol Diabetes Obes 2012;19:414-419.

6. Office of Dietary Supplements, National Institutes of Health. Dietary Supplement Fact Sheet: Iodine. Available at: http://ods.od.nih.gov/factsheets/Iodine-HealthProfessional (accessed April 23, 2013).

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This problem has been found to be especially important in post menopausal women and older men (3) who are at increased risk for fractures from worsening osteoporosis when overtreated with thyroid hormones (4). Thyroid hormones have a direct action on bone cells leading to bone loss (5) . TSH, which may play a role in protecting bone (6), is also low in overtreated patients. On the other hand, patients with hypothyroidism treated with doses of thyroxine that keep TSH within the normal range, do not appear to be at increased risk of fracture (4,7). For this reason, regular monitoring of thyroid replacement therapy every 6-12 months once stabilized, using serum TSH as a gauge, is the current standard of care (1).

This issue is again emphasized by a new study from Toronto, Canada published in the British Medical Journal examining the health records of 213,511 patients over the age of 70 years who were taking thyroxine over a 3.8 year period (8). 10.4% had a fracture during this time and 88% of the fractures were in women. The risk of fracture was almost double for those currently taking thyroid hormone as compared to those who only used it years ago. Those patients taking higher doses of thyroxine were more likely to have had a fracture than those taking lower doses. Unfortunately serum TSH data were not available so it is not certain which patients were properly treated, but it is plausible that many patients were overtreated, especially those who received higher doses. This supports the importance of avoiding overtreatment with thyroxine by adjusting the dose carefully through TSH monitoring.

Age itself is a risk factor for osteoporosis and fracture (9). Additionally, older patients need less thyroxine to maintain a euthyroid state (10,11). Failure to recognize the relationship of age and thyroxine requirements will lead to over dosage if the dose of thyroxine is not titrated down as patients age. Unnecessary treatment of elderly patients adds to this danger. The diagnosis of thyroid failure in the elderly needs to be carefully evaluated with the knowledge that the upper normal value for TSH in people over 80 yrs is ~7.5 uU/ml, compared to 4.0 uU/ml in young adults (12). Therefore careful selection of which elderly patients should be treated with thyroxine is critical. Thyroid hormone overtreatment of elderly patients is an avoidable problem.

Individuals vary in their absorption of thyroxine, sometimes because of use of interfering medications, higher thyroxine doses may be required for some patients to achieve normal TSH levels. This should not contribute to bone loss as long as overtreatment is avoided. Further, some patients with thyroid cancer need to have a lower TSH levels to prevent cancer recurrence (13). In these selected patients the risk of bone loss is outweighed by beneficial effects on control of the cancer. Hence, it is important is to adjust the dose of thyroxine to achieve TSH levels that are appropriate for each individual patient.

References:

1.  Singer PA, Cooper DS, Levy EG, Ladenson PW, Braverman LE, Daniels G, Greenspan FS, McDougall IR, Nikolai TF 1995 Treatment guidelines for patients with hyperthyroidism and hypothyroidism. Standards of Care Committee, American Thyroid Association. J A M A 273:808-812
2.  Canaris GJ, Manowitz NR, Mayor G, Ridgway EC 2000 The Colorado thyroid disease prevalence study. Arch Int Med 160:526-534
3.  Sheppard MC, Holder R, Franklyn JA 2002 Levothyroxine treatment and occurrence of fracture of the hip. Arch Int Med 162:338-343
4.  Bauer DC, Ettinger B, Nevitt MC, Stone KL 2001 Risk for fracture in women with low serum levels of thyroid-stimulating hormone. Ann Int Med 134:561-568
5.  Murphy E, Williams GR 2004 The thyroid and the skeleton. Clinical Endocrinology 61:285-298
6.  Imam A, Iqbal J, Blair HC, Davies TF, Huang CL, Zallone A, Zaidi M, Sun L 2009 Role of the pituitary-bone axis in skeletal pathophysiology. Curr Op Endocrinol Diab 16:423-429
7.  Flynn RW, Bonellie SR, Jung RT, MacDonald TM, Morris AD, Leese GP 2010 Serum thyroid-stimulating hormone concentration and morbidity from cardiovascular disease and fractures in patients on long-term thyroxine therapy. J Clin Endocrinol Metab 95:186-193
8.  Turner MR, Camacho X, Fischer HD, Austin PC, Anderson GM, Rochon PA, Lipscombe LL 2011 Levothyroxine dose and risk of fractures in older adults: nested case-control study. BMJ 342:d2238
9.  Syed FA, Ng AC 2010 The pathophysiology of the aging skeleton. Curr Osteoporos Rep 8:235-240
10.  Kabadi UM 1997 Influence of age on optimal daily levothyroxine dosage in patients with primary hypothyroidism grouped according to etiology. Southern Medical Journal 90:920-924
11.  Sawin CT, Herman T, Molitch ME, London MH, Kramer SM 1983 Aging and the thyroid. Decreased requirement for thyroid hormone in older hypothyroid patients. Am J Med 75:206-209
12. Boucai L, Hollowell JG, Surks MI 2011 An approach for development of age-, gender-, and ethnicity-specific thyrotropin reference limits. Thyroid 21:5-11
13. Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM 2009 Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid 19:1167-1214

The American Thyroid Association (ATA) is the leading worldwide organization dedicated to the advancement, understanding, prevention, diagnosis and treatment of thyroid disorders and thyroid cancer. ATA is an international individual membership organization with over 1,400 members from 43 countries around the world. Celebrating its 88th anniversary, ATA delivers its mission through several key endeavors: the publication of highly regarded monthly journals, THYROID, Clinical Thyroidology and Clinical Thyroidology for Patients; annual scientific meetings; biennial clinical and research symposia; research grant programs for young investigators, support of online professional, public and patient educational programs; and the development of guidelines for clinical management of thyroid disease.

More information about ATA is found at www.thyroid.org

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Radioactive iodine (I-131) has been used for decades as an effective treatment for thyroid cancer. Throughout this time, one important aspect of such treatment has been the protection of the public, and more specifically household contacts, from theoretically dangerous exposure to residual radiation remaining in the patient’s body after treatment. The Nuclear Regulatory Commission (NRC), an agency of the Federal government, sets the rules governing this aspect of I-131 treatment and revises them periodically¹.

In 1997, the NRC modified these regulations to allow individualization of the procedure for preventing radiation exposure to the public after a patient is treated with I-131. A goal of this rule change was to avoid isolation of a patient in the hospital for prolonged periods if the patient’s release to home would be safe for the patient, the patient’s family and the public. This approach enhances patient satisfaction and is the current standard of medical practice.

In anticipation of the Nuclear Regulatory Commission (NRC) holding meetings this week related to the use of medical isotopes and other medical issues, Rep. Edward Markey, D-Mass., and Chairman of the Energy and Environment Subcommittee, wrote to the Chairman of the Nuclear Regulatory Commission and reported a “strong likelihood that members of the public have been unwittingly exposed to radiation from patients who are discharged after being treated with radioisotopes, and that this has occurred because of weak NRC regulations, ineffective oversight of those who administer these medical treatments, and the absence of clear guidance to patients and to physicians that provide procedures to ensure that such exposures do not occur”.

The American Thyroid Association, The Endocrine Society, the Society of Nuclear Medicine, and the American Association of Clinical Endocrinologists believe that the current procedure, based on scientific evidence, is safe for patients, their families and the public when radiation safety instructions are followed (JAMA 283: 2272-2274, 2000). However, the ATA, TES, SNM and AACE would support reexamination of this issue if new data emerge that indicates concerns about public safety. Additionally, the American Thyroid Association has recently completed an examination of the current scientific evidence for any potential risks to the public from I-131 therapy of thyroid cancer. It is anticipated that the report will provide updated recommendations for best practices focusing on patient and public safety following I-131 treatment.

Our organizations are dedicated to adhering to the best medical practices for I-131 therapy so our patients, their families and the public remain safe. We look forward to discussing this important issue with relevant federal agencies. Until new regulations are released by the NRC, we recommend that physicians and patients should continue to follow current safety procedures.

For questions regarding the statement, please contact Bobbi Smith, Executive Director at the American Thyroid Association at bsmith@thyroid.org; Stephanie Kutler, Director of Government Affairs at The Endocrine Society atskutler@endo-society.org; Janette Merrill, Assistant Director, Health Policy & Regulatory Affairs at the Society for Nuclear Medicine at jmerrill@snm.org; Bryan Campbell, Director of Public and Media Relations at the American Association of Clinical Endocrinologists at bcampbell@aace.com.

¹ http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/sr1556v9r2-final.pdf#app-u

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DAT is becoming an increasingly popular option for patients wishing to monitor their health status and make more decisions about their own health care. However, the American Thyroid Association (ATA) notes several concerns about the safety and utility of making thyroid testing available directly to patients.

• Proper interpretation of thyroid function test results may not be straightforward; results can be ambiguous depending on the timing of the tests and the clinical circumstances in which they were obtained.
• Patients may be offered or advised to obtain thyroid tests out of commercial self-interest and/or in the absence of a qualified individual to interpret them or to render medical advice.
• Interpretation by unqualified individuals, and by those unfamiliar with a patient’s clinical status, may increase the chances of erroneous conclusions and improper recommendations regarding the diagnosis or the initiation/alteration of thyroid hormone therapy or other drugs that may affect thyroid status.
• Testing profiles advised by some DAT sites have unproven utility.
• Thyroid function testing by DAT is likely to be more expensive for patients because third-party reimbursements do not generally cover tests that are not ordered by patients’ physician or health care provider.

The ATA advises patients to seek advice from their healthcare provider when considering thyroid function testing via DAT. Furthermore, patients should always discuss any changes in their treatment with their providers before doing so on the basis of DAT results.

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