Tag: clinical advisory

Warning: Selenium and Zinc Picolinate-containing Products for Children

Photo by Towfiqu barbhuiya on Unsplash

Pretoria, 8 January 2026 – The South African Health Products Regulatory Authority (SAHPRA) has been made aware of products in the market containing Zinc picolinate (as a source material for zinc) and/or Selenium intended for use in children.

Both of these ingredients have been identified in the Guidance (SAHPRA Guideline 7.04 / SAHPGL-PEM-COMP-04 v5 CM SE Health Supplements) issued by SAHPRA as not permitted in health supplements for children (persons under the age of 18).

The safety concerns related to children are as follows:

  1. Zinc picolinate, at any supplemental dose, can cause side effects which include indigestion, diarrhoea, headache, nausea, and vomiting. As the bio-availability of Zn from Zn-picolinate is variable due to multiple factors, the risk of side effects may be higher and unpredictable, and it is unsuitable as a source of elemental zinc supplementation in children; and
  2. Selenium, when supplemented to children, represents a safety concern considering the potential differences in selenium daily intake between different population groups. While selenium intake is a viable requirement for children in areas of famine or dietary restriction, the potential adverse effects of selenium overdose are of concern when provided in general supplements/medicines intended for children.

The products currently on the market are marketed and sold, among others, as “Immune boosters” for children, with the main active ingredients being Zinc (when derived from Zinc picolinate) and/or Selenium intended for use in children. These products are indicated for supporting the treatment of colds, flu, diarrhoea, and skin-related conditions, rendering the products in question medicines that require registration by SAHPRA.

Any medicine sold that contains Zinc picolinate or Selenium intended for use in children does not qualify as a Category D (complementary) medicine. As such, their sale as a Category D medicine is illegal. Therefore, with effect from the date of publication of this notice, all selenium and zinc picolinate-containing products intended for use in children shall be subject to registration as a medicine falling into Category A, as defined in Section 14(2) of the Medicines and Related Substances Act, 101 of 1965, and need to be submitted to SAHPRA for registration. The sale of Category D (complementary) medicines containing Zinc picolinate or Selenium and intended for use in children must be withdrawn from the market within six (6) months of the date of this publication.

Advice for health professionals and distributors:

SAHPRA requests that Health professionals cease all distribution, selling, and/or dispensing and remove all selenium and zinc picolinate-containing products intended for use in children from stores, storage facilities, and shelves.

Members of the public are urged to return products containing Zinc Picolinate and Selenium when intended for use in children, to their pharmacist, supplying warehouse, or distributor.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product by using the Med Safety App. Your report will contribute to our monitoring of these health products.

Source: SAHPRA

Sleep Now Part of American Heart Association’s Cardiovascular Health Score

Sleeping man
Photo by Mert Kahveci on Unsplash

Sleep duration is now considered an essential component for ideal heart and brain health. Life’s Essential 8™ cardiovascular health score replaces Life’s Simple 7™, according to a new American Heart Association advisory published in Circulation.

Other updates to the measures of optimal cardiovascular health, now for anyone ages 2 and older, include a new guide to assess diet; accounting for exposure to second-hand smoke and vaping; using non-HDL cholesterol instead of total cholesterol to measure blood lipids; and expanding the blood sugar measure to include haemoglobin A1c to assess Type 2 diabetes risk.

“The new metric of sleep duration reflects the latest research findings: sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure or risk for Type 2 diabetes more effectively,” said American Heart Association President Professor Donald M. Lloyd-Jones, MD, who led the advisory writing group. “In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home.”

The Association first defined the seven metrics for cardiovascular health in 2010 to identify the specific health behaviours and health factors that drive optimal heart and brain health.

After 12 years and more than 2400 scientific papers on the topic, new discoveries in heart and brain health and in the ways to measure cardiovascular health provided an opportunity to revisit each health component in more detail. Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools. Also, the scoring system can now be applied to anyone ages 2 and older.

The Life’s Essential 8™ components of optimal cardiovascular health are divided into two major areas: health behaviours (diet, physical activity, nicotine exposure and sleep) and health factors (BMI, cholesterol levels, blood sugar and blood pressure). “The idea of optimal cardiovascular health is important because it gives people positive goals to work toward at any stage of life,” said Lloyd-Jones.

“Life’s Simple 7™ has served as a proven, powerful tool for understanding how to achieve healthy aging and ways to improve cardiovascular health while decreasing the risks of developing heart disease and stroke, as well as cancer, dementia and many other chronic diseases,” he said. “Given the evolving research, it was important to address some limitations to the original metrics, particularly in ways they’ve been applied to people from diverse racial and ethnic populations.”

Prof Lloyd-Jones explained that some of the previous metrics, such as diet, were not as sensitive to differences among people, or as responsive to changes over time within a single individual. “We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people.”

Life’s Essential 8™ includes:

  1. Diet (updated):  A new guide to assess diet quality for adults and children at the individual level (for individual health care and dietary counselling) and at the population level (for research and public health purposes).
  2. Physical activity (no changes): The optimal level is 150 minutes of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes or more per week for children ages 6 and older; and age-specific modifications for younger children.
  3. Nicotine exposure (updated): Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, is added since the previous metric only monitored traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Life’s Essential 8™ also includes second-hand smoke exposure for children and adults.
  4. Sleep duration (new): Sleep duration is associated with cardiovascular health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
  5. Body mass index (no changes): The writing group acknowledges that body mass index (BMI) is an imperfect metric, yet it is easily calculated and widely available; therefore, BMI continues as a reasonable gauge to assess weight categories that may lead to health problems. BMI of 18.5–24.9 is associated with the highest levels of cardiovascular health. The writing group notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization’s recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as  CVD or Type 2 diabetes is higher at a lower BMI.
  6. Blood lipids (updated): The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. Other forms of cholesterol, when high, are linked to CVD risk. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
  7. Blood glucose (updated): This metric is expanded to include the option of haemoglobin A1c readings or blood glucose levels for people with or without Type 1 or Type 2 diabetes or prediabetes. Haemoglobin A1c can better reflect long-term glycaemic control.
  8. Blood pressure (no changes): Blood pressure criteria remain unchanged from the Association’s 2017 guidelines that established levels less than 120/80 mm Hg as optimal, and hypertension defined as 130-139 mm Hg systolic pressure (the top number in a reading) or 80-89 mm Hg diastolic pressure (bottom number).

Each component of Life’s Essential 8™, which is assessed by the My Life Check tool, has an updated scoring system ranging from 0 to 100 points. The overall cardiovascular health score from 0 to 100 points is the average of the scores for each of the 8 health measures. Overall scores below 50 indicate “poor” cardiovascular health, and 50-79 is considered “moderate” cardiovascular health. Scores of 80 and above indicate “high” cardiovascular health. The advisory recommends measuring cholesterol, blood sugar, blood pressure, height and weight at least every five years for the most complete and accurate Life’s Essential 8™ score.

The writing group also reviewed data about the impacts of stress, mental health and social determinants of health, such as access to health care, income or education level, and structural racism, which are critical to understanding the foundations of health, particularly among people from diverse racial and ethnic populations.

“We considered social determinants of health carefully in our update and determined more research is needed on these components to establish their measurement and inclusion in the future,” said Lloyd-Jones. “Nonetheless, social and structural determinants, as well as psychological health and well-being, are critical, foundational factors in an individual’s or a community’s opportunity to preserve and improve cardiovascular health. We must consider and address all of these issues for people to have the opportunity for a full, healthy life as measured by Life’s Essential 8™.”

Source: American Heart Association