FDA data: Dietary supplement recalls relatively infrequent

By Danielle Masterson contact

- Last updated on GMT

Getty Images Lecic
Getty Images Lecic

Related tags: Fda, Dietary supplements, recall

Less than 2% of over 800 recalls initiated in 2019 involved dietary supplement products, says a new report from AHPA that supports “overall safety of the dietary supplements”.

Recall data from the Food and Drug Administration (FDA) show that 14 of 803 (1.7 %) recorded recalls initiated in 2019 involved dietary supplements, and among these, three were Class I recalls (the most serious recall class), according to a report​ published by American Herbal Products Association (APHA).

FDA assigns voluntary recalls a classification based on a health hazard evaluation:

  • Class I -- A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
  • Class II -- Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
  • Class III -- Use of, or exposure to, a violative product is not likely to cause adverse health consequences
aphagraph
Image credit: AHPA. Used with permission

Among the dietary supplements recalled between January 1, 2019, and June 26, 2019, four cases were due to risk of microbial contamination, three cases were for mislabeling, and two cases were for the presence of unlabeled allergens. During the same period, 162 food products were recalled; 73 cases were for undeclared allergens or the presence of sulfur or sulfites, 41 cases were related to microbial contamination, 26 cases were for manufacturing errors usually involving foreign material in the product, and 11 recalls were based on mislabeling.

“These recall data provide additional evidence of the overall safety of the dietary supplement class,”​ said AHPA Chief Information Analyst Merle Zimmermann, Ph.D. “AHPA also regularly reviews other dietary supplement safety resources, including mandatory serious adverse event reports and recorded observations from FDA inspections, and the results suggest that current supplement laws and regulations are working effectively to protect consumer safety and ensure a marketplace of high-quality, safe products.”

The report is the first of its kind from the trade association. APHA’s Director of Communications, Haley Chitty, told NutraIngredients-USA that they plan to continue to add data to the report and build it out over time.

aphagraph2
Image credit: AHPA. Used with permission

Related news

Show more

Related products

show more

Pronativ® | An Essential Nutrient-Rich Protein

Pronativ® | An Essential Nutrient-Rich Protein

Lactalis Ingredients | 06-Jul-2020 | Technical / White Paper

Differentiate your protein product with a nutrient-rich protein ingredient.
Pronativ® native whey protein, produced by Lactalis Ingredients, is...

DHA ORIGINS™: The sustainable potential of algae.

DHA ORIGINS™: The sustainable potential of algae.

Fermentalg | 22-Jun-2020 | Technical / White Paper

Consumers find out about nutritional quality by closely scrutinizing the labeling and list of ingredients (clean label). They are interested in the provenance...

Meriva® Curcumin Phytosome – The Life Guardian™

Meriva® Curcumin Phytosome – The Life Guardian™

Indena: botanical ingredients for the Health Food industry | 17-Jun-2020 | Technical / White Paper

Meriva® is Indena’s bioavailable curcumin – the most studied turmeric ingredient having over 30 studies with more than 2,000 individuals

Botanicals & Immunity: Trends & Research

Botanicals & Immunity: Trends & Research

Layn Natural Ingredients: Innovate With Our Botanical Extracts | 17-Jun-2020 | Research Study

Google Trends shows consumer searches of “Immunity” are up more than 700% in 2020 - and nutraceutical consumers are looking to botanicals. Find out everything...

Related suppliers

Follow us

Products

View more

Webinars