U.S. Food and Drug Administration
by Admin
Posted on 08-02-2025 01:56 PM

September 26, 2024
the u. S. Food and drug administration updated the mycotoxins in domestic and imported human foods compliance program to include the monitoring of additional mycotoxins of regulatory interest in human foods, specifically t-2/ht-2 toxins and zearalenone.
The updated compliance program also reflects the transition by fda regulatory laboratories to a multi-mycotoxin method for analysis in human foods, which will allow the agency to obtain results for multiple mycotoxins in a single sample analysis. The new data gained by the compliance program update will support enforcement actions, risk assessments, and international activities, as well as provide information on mycotoxin incidence, extent of contamination, and co-occurrence.
The food and drug administration (fda) has established advisory levels for don in finished wheat products for human consumption and grain and grain by-products used for animal feed. The advisory level of don for finished wheat products intended for human consumption (i. E. , flour) is 1 ppm (part per million, or mg/kg). There are specific advisory levels for grain and grain byproducts for beef and dairy cattle, chickens, and swine. For all other animals, the advisory level is 5 ppm, with the recommendations that the ingredients do not exceed 40% of their diet. Brewers and maltsters also use the level of 1 ppm of don as the maximum level of don allowed in malting barley.
The united states food and drug administration (fda) has developed action levels (legally allowed concentrations) for aflatoxin and advisory levels (cautionary concentrations) for fumonisins and don. In canada, health canada and the canadian food inspection agency (cfia) regulate the maximum allowable levels of mycotoxins in human food and livestock feed. The action, advisory, and maximum allowable concentrations vary by mycotoxin and the intended use of the final corn products. Up-to-date information on action levels and advisory levels for aflatoxin, don, and other mycotoxins, can be found by clicking on the fda information page on mycotoxins or health canada/cfia guidelines page.
T-2 and HT-2 Toxins
Some foods—such as grains, dried beans, dried fruits, and coffee—are susceptible to fungus or mold that produce toxins known as mycotoxins. Only certain molds and fungi can produce mycotoxins of concern. If you eat something containing high levels of those mycotoxins, you can get sick. If you eat something from an animal that ate animal food that contains mycotoxins (such as milk from a cow that ate mycotoxin-infected corn), you can get sick. As an individual consumer, you generally cannot control the presence of mycotoxins in your food. The fungi that produce mycotoxins generally grow during crop production and storage.
The impact of mycotoxins on human health is an area of concern, as these toxins are increasingly recognized for their ability to cause both acute and chronic health issues. Short-term exposure can lead to symptoms such as nausea, vomiting, and abdominal pain, which are often mistaken for common gastrointestinal disturbances. However, the long-term effects of mycotoxin exposure are more insidious and can manifest as serious health conditions. Chronic exposure, even at low levels, has been linked to the development of liver cancer, kidney damage, and immune system suppression, highlighting the need for vigilance in monitoring food safety. Vulnerable populations, including children, the elderly, and individuals with pre-existing health conditions, are particularly at risk from mycotoxin exposure.
Mycotoxin contamination is a global phenomenon and causes a wide array of negative effects and other complications. This study focused on commonly found mycotoxins in africa and the possible means of prevention or reduction of their contaminating effects. Mycotoxins are secondary metabolites of mold and fungi; they are generally toxic to living organisms. Hundreds of mycotoxins have been identified thus far, with some, such as aflatoxins, ochratoxins, trichothecenes, zearalenone, fumonisins, and patulin, considered agro-economically important. Several factors contribute to the presence of mycotoxins in food, such as climatic conditions, pest infestation, and poor harvest and storage practices. Exposure to mycotoxins, which occurs mostly by ingestion, leads to various diseases, such as mycotoxicoses and mycoses that may eventually result in death.
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Currently there are over 200 known mycotoxins (and counting) which are produced by many common molds that can exist in your home and outdoors. There is historical evidence of the presence of mycotoxins as far back as the time of the dead sea scrolls, but the chemical nature of them was not known until recently. The most commonly observed mycotoxins today which are known to have adverse effects on humans and livestock are: aflatoxins, ochratoxin a, patulin, fumonisins, zearalenone and nivalenol/deoxynivalenol. The mold that produces the mycotoxins typically grows on food stuffs such as nuts, spices, cereals, and dried fruits, but can also arise indoors on surfaces with high cellulose content such as wood, fiberboard, gypsum board, paper, dust, and lint, particularly in water-damaged or generally humid and damp environments.
Mycotoxins are toxic compounds that are naturally produced by certain types of moulds (fungi). Moulds that can produce mycotoxins grow on numerous foodstuffs such as cereals, dried fruits, nuts and spices. Mould growth can occur either before harvest or after harvest, during storage, on/in the food itself often under warm, damp and humid conditions. Most mycotoxins are chemically stable and survive food processing. Several hundred different mycotoxins have been identified, but the most commonly observed mycotoxins that present a concern to human health and livestock include aflatoxins, ochratoxin a, patulin, fumonisins, zearalenone and nivalenol/deoxynivalenol. Mycotoxins appear in the food chain as a result of mould infection of crops both before and after harvest.
The trichothecenes constitute a family of more than sixty sesquiterpenoid metabolites produced by a number of fungal genera, including fusarium, myrothecium, phomopsis, stachybotrys, trichoderma, trichothecium, and others ( 49 , 227 , 261 ). The term trichothecene is derived from trichothecin, which was the one of the first members of the family identified. All trichothecenes contain a common 12,13-epoxytrichothene skeleton and an olefinic bond with various side chain substitutions. They are commonly found as food and feed contaminants, and consumption of these mycotoxins can result in alimentary hemorrhage and vomiting; direct contact causes dermatitis ( 8 , 133 , 165 ).
Most people haven’t heard of mycotoxins, but nearly everyone has been exposed to them. Mycotoxins are poisonous compounds produced by mold and fungi found commonly in grains, fruits, and coffee. The prevalence of mycotoxin contamination is increasing with global warming. Hot, wet climates breed these toxins during the storage and processing of plant foods. Even small doses of mycotoxins can lead to serious diseases and even death. common mycotoxins cause neoplasia (cancer), while others cause kidney and neurological diseases. The dangers of mycotoxins combined with recent studies revealing widespread mycotoxin exposure have prompted researchers to declare that mycotoxins are an underappreciated cause of disease.