Tag Archives: FDA

FDA Permits Three Exceptions From Sanitary Transportation Rule

The Food and Drug Administration (FDA)  has published three waivers  to the now final Sanitary Transportation rule mandated by the  Food Safety Modernization Act (FSMA).

 The waivers are for businesses whose transportation operations are subject to separate State-Federal controls. They include:

  • Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products.

  • Food establishments authorized by the regulatory authority to operate when engaged as receivers, or as shippers and carriers in operations in which food is delivered directly to consumers, or to other locations the establishments or affiliates operate that serve or sell food directly to consumers. (Examples include restaurants, supermarkets and home grocery delivery services.)


To finish reading the article, read more at Food Safety Magazine.

Nuts over Nutella

Ah, the classic Nutella spread. Part chocolate, part hazelnut, and just 200 calories of pure deliciousness. Or is it 100 calories? Do you classify your serving as 1 tablespoon or 2? That’s what the Food and Drug Administration (FDA) wants to know.

Nutella is currently classified as a dessert topping. The serving size is two tablespoons which is equivalent to 200 calories on the Nutella jar. If it were reclassified as a spread (the same category as honey, jam, and fruit butter), the label would read 100 calories for 1 tablespoon.

Angela Chen from The Verge writes that, “100 calories per tablespoon could make people think it’s healthier than it is. People are already bad at reading food labels. We often don’t keep track of how much we eat and are easily tricked by a small number next to the “calorie” box — which is exactly what would happen in this case.”

Nutella is commonly consumed as a dessert topping. It acts as a savory spread, topping, or dip for items such as bread, bagels, ice cream, or pretzels. It is chocolaty, rich, and creamy which is why it falls into the same category as other dessert toppings like frosting and whipped cream.

Why would Ferrero (the Italian parent company of Nutella) want to consider it a jam spread? The “lower” calorie number would most likely attract customers and boost sales.

The FDA opened the floor for comments for 60 days regarding whether the popular shelf item should be listed as a dessert topping or a jam based solely on the amount the typical person eats in a single serving. So going back to the original question, 1 tablespoon or 2?

The FDA’s public commenting period closed January 3, 2017.


Is Nutella a Dessert Topping or a Spread? The FDA Wants to Know. npr.org. Retrieved from http://www.npr.org/sections/thetwo-way/2016/11/03/500572459/nutella-spurs-fda-to-ask-americans-if-its-a-dessert-topping-or-a-spread

Why the FDA wants to know how much Nutella you scoop out of the jar. washingtonpost.com. Retrieved from https://www.washingtonpost.com/national/health-science/why-the-fda-wants-to-know-how-much-nutella-you-scoop-out-of-the-jar/2016/11/04/c8c372de-a1c5-11e6-a44d-cc2898cfab06_story.html?tid=a_inl&utm_term=.e9e40b2d2d26

Mail you’d rather not get

It starts with an unannounced arrival in the lobby. A produce company is operating in full swing at its chopped bag salad plant when investigators with the Food and Drug Administration come calling for a random inspection. For the next two weeks, investigators’ eyes are on everything, pouring through records, food safety plans, collecting samples and making observations.

When their evaluation is complete, a five-page document is handed over to the food company’s senior management with a summary of the inspection. This document, known formally as an FDA Form 483, notes three separate observations recorded during the investigation, highlighting issues with contamination of surfaces, floor and wall construction, and a failure to conduct pest screening.

“Essentially, a Form 483 is like a police officer giving you a speeding ticket,” explains Shawn K. Stevens, food safety lawyer and founding member of Food Industry Counsel, LLC. “It outlines all the violations that the FDA investigators observed while inspecting your facility.”

Read More at Food Safety News

Bugs are in your food, and it’s FDA approved

Red lipstick has been a timeless staple in pop culture for as long as the beauty world can remember. But did you know the secret behind the pop of color is actually due to crushed-up insect extract?

That’s right. Bugs are the secret to fiery red lips as well as other products such as cheek blush, red gum, berry-flavored yogurt, some ice cream, some ketchup, and several others.

These not-so-mystery bugs are Cochineal insects. They’re harvested in Peru and the Canary Islands and are found on cacti. The result of the sun-dried, crushed, and soaked in acid Cochineal bug is a bright red-colored pigment. It takes about 70,000 insects to produce a pound of dye, according to Live Science.

Don’t worry, this natural coloring is FDA approved! As of 2009, the FDA states that color additives from cochineal extract can be used, but they must be labeled clearly on all food and cosmetic products in the U.S. To learn about the specifications, you can access it here.

“The U.S. food-regulating agency permits a generous threshold of insects in foods before they’re considered contaminated: up to 60 aphids in 100 grams of frozen broccoli of 550 insect fragments per average box of pasta” says National Geographic. These bugs are natural, and they’re safe to consume!

If you’re experiencing the creeps, just remember not to think about it too much. Cochineal insects are here to help, and they’re here to stay.


“Bugs are in our Food — And That’s OK.” National Geographic. Print. Feb 2017.

Guidance for Industry: Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives; Small Entity Compliance Guide. FDA.gov. Retrieved from http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm153038.htm

“Here’s what you need to know about the ground-up insects that Starbucks puts in your Frappuccino.” Business Insider. Retrieved from http://www.businessinsider.com/how-cochineal-insects-color-your-food-and-drinks-2012-3/#the-cochineal-insect-is-native-to-mexico-and-south-america-and-contrary-to-the-popular-nomenclature-theyre-not-technically-beetles-theyre-tiny-and-live-on-cactus-plants-usually-the-prickly-pear-cactus-1

“The Truth About Red Food Dye Made from Bugs.” Live Science. Retrieved from http://www.livescience.com/36292-red-food-dye-bugs-cochineal-carmine.html

Photo Attribution: here

Why are there regulations on milk?

How did regulations start?

As people moved to the cities, the milk supply became unhealthy.  Milk had to be transported longer distances and was held at higher temperatures for longer times. As a result, many people, especially children, became sick and died after consuming contaminated milk.

In the late 19th century, public health reformers started working toward a safer milk supply. One such reform was, in 1910, the city of Chicago required milk to be pasteurized.  Farmers and sellers sued the city stating that requirement was unnecessary and costly.  In 1914, the Illinois Supreme Court decision in Koy vs City of Chicago required pasteurization of milk sold in the city.  By 1920, regulations regarding milk had spread across the nation.

This proved to be a public health victory.  In 1938, disease outbreaks from milk counted for 25% of all outbreaks from food and water.  As of 2002, that number was down to 1%.

In 1924, the United States Public Health Service (USPHS), a branch of the FDA, developed what is now known as the Pasteurized Milk Ordinance (PMO).  The PMO contains provisions governing the production, processing, packaging and sale of Grade “A” milk and milk products.  This includes the barns, equipment, water, testing, cleaning, etc.  The 2013 PMO is over 430 pages.

The PMO is the basic standard used in the Voluntary Cooperative State – USPHS/FDA program for the Certification of Interstate Milk Shippers (IMS).  To be involved with Grade “A” milk, you must be “listed” in the IMS.  This includes dairy processors, laboratories, container and closures companies.  All 50 states, DC and US territories participate in the IMS program. Forty-six states have adopted the PMO for their own milk safety rules. The other 4 states have passed laws very similar.

Federal law prohibits the interstate sale of raw fluid milk.  In 1987, the FDA banned the state-to-state shipping of raw milk. They mandated the “pasteurization of all milk and milk products in final package form for direct human consumption.”


Why pasteurize?

The leading human illnesses attributed to milk before pasteurization were brucellosis, diphtheria and tuberculosis.  These are well-controlled or virtually eliminated in modern dairy herds in the United States. They do still occur in other countries.

Predominant illnesses today from raw milk and raw milk products are normally caused by Salmonella sp, Campylobacter sp, E. coli and Listeria sp.

RAW MILK OUTBREAKS in unpasteurized (raw) milk and raw milk products, United States 1998 – 2013       (15 years)

136 total outbreaks

102 were from fluid milk

28 were from raw milk cheese.

6 wer from multiple raw dairy products.

2,468 total illnesses, 2 deaths

1,803 fluid milk-related illnesses.

608 cheese-related illnesses, 2 deaths

57 illnesses from multiple raw dairy products.

From January 2015 to March 2016 (15 months), there were 15 recalls of unpasteurized milk.  The states include California (4), Pennsylvania (3), New York (3), Washington (2), Idaho, Tennessee and Indiana.

The contaminates were Campylobacter sp. (7), Salmonella sp. (2), E. coli 0157:H7 (4), Listeria sp. (4), and Cryptosporidium (1).   Two recalls were for more than one contaminant. Some recalls were in response to routine testing that yielded positive results. Others were due to illnesses related to the consumption of raw milk.  In states that allow the sale of raw milk, there are mandatory testing requirements of the raw milk that vary from state to state.  Some states require routine pathogen testing, while others do not until there is a complaint or outbreak.


How does raw milk get contaminated?

There are many avenues for contaminates to get into the raw milk.  It can come from the processing equipment such as the milking equipment, lines, tanks and containers. milking-1466846-640x480

Environmental factors can include dirt, mud, fecal matter in the straw, and standing water in the area.

Cows at feeding time on the dairy farm. Rear view

Rodents, including mice, rats, insects and chicken and poultry can contaminate the area and the milk.field-mouse-1526371-640x480 (1)

Other avenues can come from the humans on their boots, gloves, hands and soiled clothing. boots-1238700-639x852

The animals themselves can be the source of contamination due to the inadequate cleaning of the udders, broken skin or illness.

What testing is done?  Report to follow.

What Does That Food Label Mean?

In the US, food labels are required for most prepared foods.  They are mandated to list several things such as calories and dietary fiber. The label must also include any vitamins or minerals added to enriched foods.  Specific additives such as color additives must also be listed.  Finally, the FDA requires labeling of ingredients that can impact human allergies, such as milk or nuts. All of these requirements are based on scientific and medical guidance.

Recently, companies have been adding labels to increase the marketability of their products by appealing to the health consciousness of the consumer. There are FDA-approved descriptors and claims that may be added to food labels. The FDA seeks voluntary compliance from the food companies for science based labeling.  The labels are to use statements that are truthful and not misleading. They should not state or imply that organic food is superior to traditional food products.

Antibiotic Free

  • “No Antibiotics added” indicate livestock was raised without the use of antibiotics. It should also indicate that the claim is USDA verified.
  • “Antibiotic-free” is not authorized or approved by the USDA.
  • All meat is free from antibiotics due to governmental regulations and farmers compliance. After treatment with antibiotics, there is a mandatory withdrawal period to ensure there are no antibiotic residues in the animal.
  • All milk is free from antibiotics for the same reason.  Cows being treated are milked separately and that milk is destroyed. The animal has a withdrawal period and milk is tested for residue before it can be returned to the herd. The milk is also retested before it is unloaded from the tank.

All Natural

  • According to the FDA, “it is difficult to define a food product as ‘natural’ because the food has probably been processed and is no longer the ‘product of the earth'”.
  • The FDA has not developed a definition, but does not object to the use of the term if the “food does not contain artificial colors, flavors or synthetic substances.”
  • The USDA classifies “minimally processed foods without artificial ingredients” as natural.

No Hormones

  • “No added hormones” indicates no hormones were administered during the animal’s lifetime.
  • FACT: Hormones are approved for the use in beef cattle and lamb production.
  • FACT: The use of hormones is not permitted in pork or poultry.  Using “hormone-free” or “no hormones added” labels on pork or poultry is false advertising.

Free Range

  • The USDA does not define that term for labeling.
  • The required provisions for the “free range” label use include unlimited access to food, fresh water and continuous access to outdoors.
    • Continuous access to the outdoors can mean many things. They may have access, but may prefer to stay inside with the food and water. Windows count as access.
    • Access may mean more space, but with poultry, that can lead to increased aggression and injury and worse air quality. Yes, the “pecking order” is real.

Grass Fed

  • After weaning, livestock is fed nothing but grass and other forages. 
  • Other forages include grasses, cereal grains in the pre-grain state, hay, haylage, baleage, silage, legumes and crop residue.
  • Animals must have continuous access to grass during the growing season. There are no other regulations other than what is applied to conventionally raised livestock.


  • Organic foods are produced according to the standards in the Organic Food Production Act (OFPA). An Organic label means:
    • “The use of irradiation, sewage sludge, synthetic fertilizers, prohibited pesticides and genetically modified organisms is not permitted.”
    • Livestock is produced according to health and welfare standards.  No antibiotics or growth hormones can be used. Livestock is fed with 100% organic feed and provided access to the outdoors.
    • 95% of the ingredients of a multi-ingredient food must also be organic.
    • Before products can be labeled USDA Organic, a USDA-accredited certifying agent must verify the practices as compliant.
  • According to the Mayo Clinic, organic food is not safer or healthier than conventionally grown foods.

USFDA "Labeling & Nutrition. July 2015
MedlinePlus. Food Labeling.15 May 14.
USFDA. "What is the meaning of 'natural" 8 Jun 15
National Chicken Council. "Chickopedia. 20 Jul 15
Consumers Reports. June 2012
Wall Street Journal.  19 May 2016
USDA Agriculture Marketing Service Grading, Certification & Verification. 29 Sep 08
USDA "Meat & Poultry Labeling Terms"  24 Oct 14
USDA "Organic Standards" 11 Jun 15
Mayo Clinic. "Organic foods: Are they safer?"  Mayo Clinic 9 Jun 14
Illinois Farm Bureau

FDA and the PMO


Final Rule for Preventive Controls for Human Food as it Relates to Dairy Products Produced under the Pasteurized Milk Ordinance (PMO)

FDA website as of 02 December 2015.

PMO.1. Do facilities operating under the PMO meet the requirements of the final preventive controls rule?
The preventive controls provision of FSMA (section 103) does not exempt dairy facilities that are required to register with the FDA. The 2013 PMO does not address all of the FSMA requirements, such as a written hazard analysis, those relevant to food allergens, or the potential presence of environmental pathogens in the food processing environment. Such provisions in the Preventive Controls rule could help prevent food safety problems from the consumption of food produced in PMO facilities. At its biennial conference in April 2015, the National Conference on Interstate Milk Shipments (NCIMS) initiated work to modify the PMO; therefore we are extending the compliance date for PMO-regulated facilities to comply with the rule in order to make use of the existing system of state regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO.

PMO.2. Does the preventive controls rule apply to dairy farms?
Establishments that meet the definition of a farm are not required to register under section 415 of the Food, Drugs, and Cosmetics (FD&C) Act. However, farms, including dairy farms, that conduct manufacturing/processing activities beyond those included in the farm definition in the Preventive Controls rule are subject to registration and would be subject to requirements of the Preventive Controls Rule unless a specific exemption applies.

PMO.3. What environmental and product testing for milk and dairy products is required under FSMA and the preventive controls rule?
The Preventive Controls Rule includes requirements for environmental monitoring and finished product testing as verification activities that would be applied as appropriate to the food, the facility, and the preventive control. Such testing would be appropriate for certain ready-to-eat dairy products, e.g., environmental monitoring for Listeria spp. in facilities making soft cheeses that are exposed to the environment.

FDA Seeking Information on Raw Milk Cheese

On Monday, the U.S. Food and Drug Administration (FDA) started collecting public comments on cheese made from unpasteurized milk.

Agency officials want any information or scientific data that would help them identify and evaluate measures that might minimize the impact of pathogens in raw milk cheese.

The public comment period will remain open for 90 days from Aug. 3.

Read more here.