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CRN Issues Guidelines for Melatonin Products

The Council for Responsible Nutrition issued voluntary guidelines for the labeling and formulation of melatonin-containing dietary supplements for sleep support.

Dietary supplement companies that are offering melatonin products may want to revamp their formulation and labeling, after voluntary guidelines were released by the Council for Responsible Nutrition (CRN) around this product category. The association recommends that in addition to complying with current labeling laws and regs, dietary supplements containing melatonin and marketed for sleep support should be formulated and labeled to provide no more than 10 mg/d of melatonin when used as directed. In addition, CRN suggested product labels include the following statements or similar language:

  • Consult a healthcare professional:
    • If you are experiencing long-term sleep difficulties.
    • Before use in children.
    • Before use in pregnant or nursing women, those with a medical condition, and those taking medication.
  • Do not drive or operate machinery when taking melatonin.

In making these recommendations, CRN looked at dosages of melatonin used in clinical studies, as well as those assessed by scientific and regulatory authorities including the Institute of Medicine and Health Canada. The guidelines are focused on melatonin products for sleep support only; other uses of melatonin, such as antioxidant support and immune health, were not addressed. CRN’s Andrea Wong, Ph.D., vice president, scientific and regulatory affairs, said that was because sleep support is the primary usage area and also where the majority of data identified were.

According to a report from Transparency Market Research, the global demand for melatonin is expected to reach $1.3 billion by 2019, growing at a CAGR of 14.7 percent between 2013 and 2019. The market research firm noted that rising stress levels and the dietary supplement status of melatonin in the United States are driving sales in that geo, with high customer awareness and a comparative lack of side-effects compared to other sleep aids giving melatonin an edge in this area.

While melatonin has been available as a dietary supplement for sleep support for many years, Wong said the association has seen growing interest in the category. “The use of melatonin-containing dietary supplements has become increasingly popular in recent years, with 6 percent of supplement users taking melatonin according to CRN’s 2014 Consumer Survey," she said. “The development of the guidelines was a proactive effort by CRN to encourage responsible, consumer-focused behavior by providing science-based recommendations on labeling and formulation."

These recommended guidelines join others developed by CRN including ones addressing iodine quality in multis for pregnant and lactating women; caffeine-containing supplements; and labeling of protein in supplements and functional foods.

At SupplySide West this fall in Las Vegas, Jeremy Appleton, N.D., will be speaking on the INSIDER Education Track on formulating effective products for sleep and relaxation. The session is set for Tuesday, Oct. 6, from 1 to 1:50 p.m., and will cover topics including common causes of disturbed sleep, classes of dietary ingredients that affect sleep, and formulation strategies for product success. You can find more about this session, and get registered for the show, at http://west.supplysideshow.com/edu-more.aspx.

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