The following is attributed to Jim Jones, the FDA's Deputy Commissioner for
Human Foods
SILVER
SPRING, Md., Aug. 15,
2024 /PRNewswire/ -- Last fall, the U.S. Food
and Drug Administration and our regulatory health partners at the
North Carolina Department of Health and Human Services, the North
Carolina Department of Agriculture & Consumer Services, the
Maryland Department of Health and the Pennsylvania Department of
Agriculture initiated an investigation of apple cinnamon fruit
puree pouches that were recalled after they were found to be
contaminated with harmful levels of lead and chromium.
The harmful levels of lead prompted us to work with Austrofood
to quickly voluntarily recall the impacted product. Austrofood is
the manufacturer of the recalled pouches and manufactured the
pouches at the company's Ecuadorian facility. The FDA's leading
hypothesis is that the contamination of the cinnamon was an act of
economically motivated adulteration. The FDA has initiated
additional efforts to prevent future lead-related incidents,
including taking a closer look at cinnamon and other spices in our
food supply, especially those in foods that are often consumed by
babies and young children.
On Aug. 9, the FDA issued a
warning letter to Austrofood, the manufacturer of the apple
cinnamon fruit puree pouches that were recalled last fall. The
warning letter cites Austrofood for violations of the Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food rule (PC Human Food Rule). Before
the recall, Austrofood did not appropriately conduct a hazard
analysis to identify and evaluate a known or reasonably foreseeable
hazard (in this case, lead in cinnamon as an ingredient in apple
cinnamon fruit puree pouches) to determine whether that hazard
required a preventive control. The letter states that considering
the known prevalence of lead in spices such as cinnamon and the
intended consumers of the finished product, including particular
susceptibility of young children to the negative health effects of
lead exposure, a knowledgeable person at the Austrofood facility
would identify lead in the cinnamon as a hazard requiring a
preventive control.
The warning letter also states that the presence of the levels
of lead in the apple cinnamon fruit puree pouches causes these
products to be adulterated under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) because they bear or contain an added
poisonous or deleterious substance which may render them injurious
to health. By shipping the apple cinnamon fruit puree pouches to
the U.S., Austrofood caused the introduction or delivery for
introduction into interstate commerce of adulterated food in
violation of section 301(a) of the FD&C Act.
This warning letter is one example of our continued action to
ensure the safety of cinnamon and other spices in our food
supply.
Earlier this year, the FDA initiated targeted sampling and
testing of cinnamon sold at discount retail stores. This effort led
to the voluntary recall of certain ground cinnamon
products sold by a number of brands at six different retail
chains that were found to contain elevated levels of lead.
Our state partners have also been continuously sampling and
testing pure ground cinnamon products in the marketplace for levels
of lead. These surveillance activities uncovered the elevated
levels of lead in certain ground cinnamon products sold at retail
stores, which led to additional ground cinnamon recalls and the
issuance of two public health alerts in late July. We appreciate
our state partners who continue to monitor cinnamon in the
marketplace across the country.
Protecting our food supply, especially foods intended for babies
and young children, is an agency priority – but also a task that
requires partnership and collaboration. Industry is the first line
of defense when it comes to upholding the safety of the products
that make it to store shelves. That's why in a letter sent in
March, we also reminded manufacturers, processors, distributors and
facility operators who process or handle cinnamon of their
responsibility to follow the PC Human Food Rule.
The March letter to industry further explains that lead is often
found in spices, including cinnamon, from the environment where it
is grown or processed. Lead can also be present through the
intentional addition to spices (e.g., turmeric, paprika, and
cinnamon powder), likely for economic gain. Manufacturers of such
products are required to appropriately analyze hazards and take
steps to prevent hazardous products from entering the U.S. food
supply.
Our work in this space is also focused on implementing a
strategic, long-term iterative approach to reducing childhood
dietary exposure to lead, arsenic, cadmium and mercury through the
FDA's Closer to Zero initiative. We're focused on reducing dietary
exposure to environmental contaminants to as low as possible, while
maintaining access to nutritious foods. As part of this initiative,
in Jan. 2023, the FDA published draft
action levels for lead in foods intended for babies and young
children and is aiming to issue a final guidance in 2024.
Additionally, we are asking Congress for the authority to
establish binding contamination limits in foods, including those
consumed by infants and young children, via an administrative order
process. Such binding limits would require industry to ensure only
an allowable amount or less of a contaminant such as lead, arsenic,
cadmium and mercury be in a food product. This new authority
would not only provide us a faster way to establish binding limits
but also an expeditious way to update limits as new scientific
information becomes available.
The FDA is also seeking authority to require industry to test
final products for contaminants and to maintain records that the
FDA could remotely access and review. Additionally, the FDA is
seeking to expand the agency's mandatory recall authority to
mandate recalls for more contaminated foods or ingredients. This
new authority would help us to better understand levels of
contaminants in foods, allow the FDA to monitor industry progress
in reducing levels over time and identify where we should devote
more time and resources to better protect infants and young
children.
In addition, the FDA is continuing oversight of foreign firms
and imported foods, including through increased and more targeted
import screening. As such, the agency has also placed
Negasmart, the distributor of the cinnamon used in the contaminated
applesauce products, on multiple import alerts, including Import
Alert 99-47 regarding products that appear to be adulterated
for economic gain and Import Alert 99-42 for products that are
contaminated with heavy metals and appear to be adulterated under
section 402(a)(1) of the FD&C Act.
Myself and colleagues in the FDA's human foods program continue
to remain steadfast in our dedication to enhance the safety of
cinnamon, ground spices, and other products sold in the U.S.,
reduce dietary exposure to heavy metals and work with federal and
state partners to reduce contaminant levels in food products
particularly those consumed by babies and young children. We will
continue to provide additional updates on our post-incident
response page.
Related Information
- Constituent Update: FDA Issues Warning Letter to Manufacturer
of Apple Cinnamon Fruit Puree Products Containing Elevated Levels
of Lead and Chromium
- Warning Letter to AUSTROFOOD S.A.S. (Austrofood)
- Post- Incident Response Activities: Elevated Lead and Chromium
Levels in Cinnamon Applesauce Pouches
- Investigation of Elevated Lead & Chromium Levels: Cinnamon
Applesauce Pouches
Media Contact: Enrico
Dinges, 240-620-9293
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/fda-issues-warning-letter-to-austrofood-and-continues-robust-activities-to-ensure-safety-of-cinnamon-products-sold-in-us-302223822.html
SOURCE U.S. Food and Drug Administration