Red food dye: Toxic or tame?

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Announced on January 15, 2025, this ruling comes after decades of debate and advocacy, highlighting the complex interplay between scientific evidence, regulatory processes, and public opinion on health concerns.

Red Dye No.3, your days are numbered ...This decision is based on the Delaney Clause, a portion of the law from in the 1950s, which requires the FDA to ban any additive found to cause cancer in animals and humans. This is regardless of the relevance to human health at typical exposure levels.

However, some experts say the laws must evolve with current studies on the subject matter, which are more accurate than those conducted in the ’50s, when the law served mostly as a “catchall” for food safety.

But how much is really too much when it comes to human health?

Studies on Red Dye Toxicity

While we know too much of any one thing is bad for us, this development has sparked discussions about the scientific thresholds for determining food additive safety, the timeline for implementing such bans, and the broader implications for food manufacturers and consumers alike.

Several studies have shown the potential toxicity of red dyes, particularly Red Dye No. 3. Here’s an overview of the key findings and regulatory actions:

  • Cancer in Lab Animals: Studies conducted over 30 years ago found that Red Dye No. 3 caused cancer in male rats when administered at high doses. This was the primary basis for regulatory action.
  • DNA Damage: A 2001 study published in Toxicological Sciences showed that Red Dye No. 40 (Allura Red) induced DNA damage in mice, particularly in their colon epithelium cells.
  • Recent Research: A 2023 study in mice indicated that Red Dye No. 40 might cause DNA damage and affect the microbiome, potentially contributing to colonic inflammation.

As you can see from the above-noted studies, research on red dye toxicity has primarily focused on animal models, with thresholds for damage in humans remaining unknown.

Scientific Thresholds and Human Cancer Risk

In 1969, Red Dye No. 3 was approved for use in food and ingested drugs. FDA declined to permit Red Dye No. 3 for use in cosmetics and topical drugs in 1990 based on the aforementioned studies showing cancer development in male rats exposed to high levels of the dye. The FDA’s 1990 decision did not revoke the approval for food and ingested drugs.

However, there is no evidence that  Red Dye No. 3 causes cancer in humans. 

According to Market Watch and their interview with Scott Keatley, a registered dietitian and co-owner of Keatley Medical Nutrition Therapy, a practice in New York City:

Keatley found that for a 50-pound child, that would equate to 12 red gummy bears, or 6 pieces of red licorice, or half a cup of red gelatin dessert EVERY day

For a 150-pound adult, the math would work out to triple those amounts — or about 36 red gummy bears per day…that’s a lot of candy. 

Furthermore, the FDA has stated in their press release on the ban that the mechanism by which Red Dye No. 3 causes cancer in male rats “does not occur in humans…studies in other animals and in humans did not show these effects”.

The FDA also maintains that “claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information”.

While we know the evidence for human cancer risk is inconclusive, the Delaney Clause meant that the FDA was required to take action against Red Dye No. 3.

Research on other synthetic food dyes, particularly Red Dye No. 40, is ongoing, with some studies suggesting potential health concerns that warrant further investigation.

Will this be a domino effect?

While no immediate bans have been announced, there are indications that other additives might face similar scrutiny in the near future. Watchdog groups are already calling attention to other potentially harmful additives. A health watchdog has warned about three other food additives linked to cancer following the Red Dye No. 3 ban.

The FDA’s decision to act on Red Dye No. 3 after decades of inaction may signal a shift towards more proactive regulation of food additives.

Consumer advocacy groups, emboldened by the success with Red Dye No. 3, may increase pressure on the FDA to review other controversial additives. For example, the Center for Science in the Public Interest (CSPI), which petitioned for the Red Dye No. 3 ban, may target other additives.

This ban aligns the U.S. more closely with regulations in the European Union, which previously banned Red Dye No. 8, except for cocktail cherries, cosmetics, pharmaceuticals and toothpaste. Additional regulations exist in Australia and New Zealand, where many additives are already restricted. This international context may influence future FDA decisions on other additives.

While it’s uncertain which specific additives might be banned next (e.g., Red Dye No. 40), the Red Dye No. 3 decision has likely opened the door for increased scrutiny of food additives with longstanding safety concerns or those already restricted in other countries.

The food industry and consumers should be prepared for potential changes in the coming years as the FDA and advocacy groups continue to evaluate the safety of various food additives.

How will this ban impact food manufacturers?

Many food manufacturers are already exploring alternative natural color additives without impacting the flavor.

There are many substitutes for Red Dye No. 3, such as beet juice, purple sweet potato extract, red cabbage extract, carmine, and pomegranate juice. These natural substitutes align with growing consumer preferences for clean-label ingredients. After all, many of us would rather consume pomegranate juice in Jell-o than red dye.

The state of California has already passed its own ban of Red Dye No. 3 that goes into effective January 1, 2027, so many companies are already preparing for this transition. But we are contending with a lot of items: approximately 3,000 items sold in the United States include Red Dye No. 3, such as baked good, candies, and strawberry meal replacement shakes.

Food manufacturers have until January 15, 2027, to reformulate their products, while drugmakers have until January 2028. Some manufacturers may wait closer to the deadline to implement these new ingredients into their production lines due to higher short-term costs.

Why is this issue the FDA’s focal point right now?

Here’s the deal: we know red dye is simply a color additive in food, is not a preservative or flavor mechanism and is not necessary for food products. We also know that we are not going to give our children 12 red gummy bears every day.

The real nutritional concern should be excess sugar, insufficient protein, and a diet high in sodium. Are children getting their daily requirement of fruits, vegetables, and fiber? A more relevant question for the FDA is: How can we help our nutritionally-deficient children have healthy diets?

Ultimately, the current push to ban red dye is as much about legal regulations as it is about nutrition. While there is no evidence to suggest that red dye causes cancer in humans, the FDA is required to follow the Delaney Clause.

How Will Tariffs Affect Overseas Trade?

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As we dive into the complex world of ocean freight’s role in U.S. food imports and exports, it’s clear that the agricultural trade and transport landscape is facing some pretty choppy waters ahead.

The Current State of U.S. Agricultural Trade

Before we delve into the potential impacts of new tariffs on ocean transport, let’s take a snapshot of where U.S. agricultural trade stands today.

According to the latest data from the U.S. Department of Agriculture’s Economic Research Service (USDA ERS), U.S. agricultural exports for fiscal year 2025 are forecasted at a whopping $170 billion.

That’s a lot of soybeans, corn, and beef making their way to dinner tables around the world.

On the flip side, we’re also bringing in quite a feast from abroad. U.S. agricultural imports for the same period are projected to reach $212 billion.

From avocados to wine, our taste for international flavors continues to grow, leading to the largest trade deficit seen in over 65 years.

As an FYI, Garland’s recent post, Tariffs: Economic Boost or Negotiating Tool? does a great job exploring tariffs and their economic and political implications — we highly recommend the read.

The Ocean Freight Connection

Now, you might be wondering, how do all these agricultural products travel around the globe? The answer is primarily by sea. Ocean freight plays a crucial role in the movement of agricultural goods, both in and out of the United States.

Exports

If you’re surprised by this, you have good reason: while container shipments only account for a quarter of U.S. agricultural exports by volume, they represent over half of the value of our total exports. That’s a lot of high-value goods sailing the seven seas. The destinations receiving the bulk of these goods are China, Canada, and Mexico.

The busiest port in the U.S., the New Orleans Port Region, moves almost 40% of all U.S. waterborne ag exports alone.

Most of these exports were bulk grains and products, like corn, soybeans, animal feed, and rice. Other significant exports from this port include soybean and corn oils and frozen poultry.

But Gulf ports like New Orleans don’t just export ag products.

In fact, the value of ag exports is a small portion of the total value of all goods. Because of the relative proximity of products to Mississippi River, these Gulf ports constantly crank out enormous amounts of oil and gas, chemicals, and ores, providing a cost-efficient transport corridor. Houston and New Orleans alone account for about 65% of total U.S. oil and petroleum exports.

Imports

The European Union and Mexico are the second and third largest countries in terms of agricultural imports into the U.S. Products received from these partners are mostly comprised of tropical fruits, sugar, soybeans, and packaged grocery and beverage items.

New York and Philadelphia rank highest on the receiving end for 2023, accounting for 17% and 7% of imported goods, respectively.

Trump’s Tariff Proposal: A New Trade Storm Brewing?

Now, here’s where things get interesting.

President Trump plans to impose 25% tariffs on Mexico and Canada set to take effect in March 2025, postponed from February 1. This ongoing negotiation has the attention of food producers, as Mexico has become one of our largest trading partners and increasingly important export markets for U.S. farmers in recent years, with most goods traveling overseas.

Trump has also directed federal agencies to review trade pacts with China. This has many farmers recalling Trump’s first term in office. As a result of retaliatory tariffs from the onset in summer 2018 through the end of 2019, the USDA ERS reported that U.S. agricultural export losses exceeded $27 billion, with soy and pork producers hit particularly hard.

China’s swift retaliation accounted for about 95% of the value lost, but our losses were significantly mitigated by an outstanding trade agreement with China to purchase U.S. soybeans, leaving many questioning how losses might affect us next time around.

Potential Outcomes on U.S. Ag Trade

In what ways could these tariffs affect U.S. farmers and exporters? A number of things could happen that disrupt our current flow of goods, both incoming and outgoing. And these factors affect one another, leading to thorny diplomatic situations with various scenarios to navigate.

Let’s break down these potential situations:

  • Reduced Competitiveness: New tariffs could make U.S. exports less competitive on the global stage. This could open the door for competitors like Brazil to gain more market share, particularly in soybean exports.
  • Retaliation Risks: If history is any guide, we might see retaliatory tariffs from affected countries. During the 2018-2020 U.S.-China trade war, U.S. soybean exports to China plummeted from $14 billion in 2016 to just $3 billion in 2018 – a staggering 78% decrease.
  • Market Disruptions: The tariffs could disrupt established trade flows. For instance, Mexico is a major supplier of fresh fruits and vegetables to the U.S.
  • Price Fluctuations: Tariffs could lead to price increases for a wide variety of food and beverage products, affecting both consumers and the food industry.
  • Potential Export Losses: During the previous trade war, U.S. agricultural producers faced approximately $27 billion in lost exports between 2018 and 2019, with soy and pork producers hit particularly hard.

For more information on these scenarios, refer to our article, Tariffs: Economic Boost or Negotiating Tool?

Freight Impacts from Trade Tensions

Now, let’s consider how these potential tariffs might affect ocean freight costs. It’s a bit like predicting the weather – there are many factors at play, but we can make some educated guesses based on past experiences and current trends.

  • Demand Fluctuations: If tariffs lead to reduced trade volumes, we might see a decrease in demand for shipping services. This could potentially lead to lower freight rates in the short term.
  • Route Changes: Tariffs might cause shifts in trade routes as countries seek new markets or suppliers. This could impact shipping patterns and potentially affect freight rates on certain routes.
  • Uncertainty Premium: The uncertainty created by trade tensions and changing policies could lead to volatility in freight rates as shipping companies try to navigate the new landscape.
  • Capacity Adjustments: If trade volumes decrease significantly, shipping companies might reduce capacity by idling ships or slowing vessel speeds. This could eventually lead to higher freight rates as supply adjusts to demand.

The Bigger Picture: Beyond Tariffs

While tariffs are grabbing headlines, it’s important to remember that they’re just one piece of the complex puzzle that is international trade.

Several factors beyond tariffs can significantly influence U.S. agricultural exports and ocean freight costs.

Of course, there are the immediate costs of maintaining these ships and its transport across the world. Operators of these vessels must contend with the ever-changing costs of fuel, accounting for about 40% of total costs. Insurance and labor also factor in, but the fees associated with port and custom fees also command a significant chunk of its operations.

External factors out of the operator’s control make the industry far murkier. The overall health of the global economy plays a crucial role in determining the demand for U.S. agricultural products. And this is largely driven by the supply and demand cycle of the industry —  a constant balancing act between volume of goods and ocean freight capacity. Add in the effects of unpredictable weather patterns and crop yields, and you’ve got the perfect conditions for volatile capacity constraints.

Additionally, fluctuations in the value of the U.S. dollar can impact the competitiveness of U.S. exports in international markets. And the ever-changing landscape of environmental standards for shipping can also have implications for freight costs in the coming years, as the industry adapts to more sustainable practices and technological innovations.

But timing is everything when it comes to the ocean freight market. Because of these variables, operators will often book freight far in advance as an economic hedge for rising costs. This means the shorter-term factors cited above are a bit secondary to the market’s perception of overall economic drivers.

Looking Ahead: Navigating Choppy Waters

As we look to the future, it’s clear that U.S. farmers and exporters may need to brace for some chop ahead. The potential implementation of new tariffs could reshape the landscape of agricultural trade, impacting everything from commodity prices to shipping routes.

However, it’s not all doom and gloom. The resilience and adaptability of the U.S. agricultural sector have been tested before, and farmers have shown remarkable ability to weather economic storms. Moreover, the increasing global demand for food provides a strong foundation for U.S. agricultural exports in the long term.

And it’s important to note that tariffs can be used as a negotiation tool, as well as instigating action from our trading partners. Should Canada and Mexico curtail illegal immigrants coming across the U.S. border, tariffs would be expected to dissipate. We would also expect a similar change to tariffs with China, should fentanyl and other dangerous substances cease to enter the U.S.

As consumers, we might see some changes in the prices and availability of certain products, particularly those that rely heavily on imports or exports affected by the tariffs. However, the diverse and robust nature of the U.S. food system should help mitigate major disruptions.

Can a Small Food Label be a Big Deal?

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Imagine strolling down the supermarket aisle, your eyes drawn to a small, simple, black-and-white box on the front of food packages. This isn’t just another marketing gimmick – it’s the FDA’s latest weapon in the battle against chronic diseases.

The proposed “Nutrition Info box” is set to transform how Americans shop for food, offering a quick “Low,” “Med,” or “High” snapshot of saturated fat, sodium, and added sugars content. And it has been a long time coming.

A nutritional revolution on your grocery shelves

Slated for potential implementation between 2029-2030, front-of-package (FOP) label regulations will fundamentally transform how consumers interact with food packaging, potentially impacting food manufacturers’ reformulation strategies and market positioning.

Driven by the alarming prevalence of chronic diseases and escalating healthcare costs, the FDA’s initiative goes beyond mere labeling—it’s a strategic intervention aimed at empowering consumers to make more informed dietary choices.

While the EU and Chile have been using a colorful traffic light system, the FDA is taking a more subtle approach. The proposed design aims to provide clear information without the potential alarm of red warning signs. It’s like comparing a minimalist art piece to a vibrant street mural – both eye-catching, but with different emotional impacts.

Why now? The chronic disease crisis

With 60% of Americans battling at least one chronic disease and healthcare costs soaring to $4.5 trillion annually, the FDA is pulling out all the stops. This label isn’t just about information – it’s a public health intervention disguised as packaging design. As FDA Commissioner Robert M. Califf puts it, “It is time we make it easier for consumers to glance, grab and go”.

This labeling revolution could spark a domino effect in the food industry. Manufacturers might scramble to reformulate products, turning the supermarket into a battlefield of nutritional one-upmanship. It’s like giving consumers X-ray vision for nutrition, potentially transforming the food landscape one package at a time.

In the end, this small label could be the catalyst for a healthier America, proving that sometimes, the biggest changes come in the smallest packages.

When will we see these in effect?

The FDA’s proposed rule on FOP nutrition labeling is currently open for public comments until May 16, 2025. After this period, the FDA will review the comments and potentially make revisions before issuing a final rule, which can take several years. Once finalized, large companies with $10MM+ in food sales have 3 years to implement; small companies have 4 years.

The FOP labeling requirement will impact most food manufacturers producing packaged foods that currently bear a Nutrition Facts label.

However, there are some exemptions, including:

  • Foods in packages with a total surface area of less than 12 square inches
  • Packages marketed as gifts containing a variety or assortment of foods
  • Unit containers in multiunit retail food packages

Assuming the rule is finalized without significant delays, consumers might start seeing the new FOP labels on shelves as early as 2029 for products from large manufacturers, and 2030 for products from smaller companies. However, this timeline could vary depending on the duration of the FDA’s review process and any potential challenges to the rule.

What are the economic impacts to the food industry?

Here are some of the potential economic impacts on the food industry:

  • Reformulation Costs: Many food manufacturers are likely to reformulate their products to meet new “healthy” criteria. This could lead to substantial upfront research and development expenses until economies of scale are achieved
  • Price Changes: There’s evidence of a 5.5% increase in prices of unlabeled products relative to labeled ones due to regulations. This suggests that companies may adjust pricing strategies to offset costs or capitalize on perceived healthier options.
  • Demand Shifts: Products receiving labels, especially those previously perceived as healthy, could experience up to a 40% decrease in demand. This may lead to revenue losses for some manufacturers and gains for others producing healthier alternatives.
  • Compliance Costs: The industry will face expenses related to implementing new labeling requirements, including design changes and printing costs.
  • Potential Cost Savings for U.S.: Despite initial costs, the regulations could lead to long-term healthcare and societal cost savings. The US calorie menu labeling law alone is estimated to result in net lifetime savings of $10.42 billion from a healthcare perspective and $12.71 billion from a societal perspective.
  • Market Differentiation: Some companies may benefit from increased product differentiation, potentially allowing for premium pricing of healthier options.
  • Industry-wide Impact: Experts estimate that food fraud, which stricter labeling aims to combat, affects 1% of the global food industry at a cost of about $10-$15 billion annually. New regulations could help reduce these losses.

Overall, while there are significant upfront costs for the food industry, the long-term economic impacts could be positive, especially when considering broader societal benefits and potential market opportunities for healthier products.

How does this new label compare to other countries?

The new FOP labeling regulations differ from those implemented in other countries in several key aspects:

Comparison with European Union (EU)

  • Approach: The US proposes a black-and-white design, while the EU uses a colorful traffic light system.
  • Additive labeling: The EU assigns E-numbers to additives, while the US requires full names on labels.
  • Nutrient disclosure: US labels tend to provide more detailed nutrient information compared to EU labels.

Comparison with Chile and Americas

  • Stringency: The proposed US regulations are less stringent compared to Chile’s and the Pan American Health Organization’s (PAHO) criteria.
  • Coverage: Under current proposals, 54.4% of packaged products in the US would require FOP labels, compared to 68.4% in Chile and 81.3% under PAHO criteria.
  • Ultra-processed products (UPPs): The US criteria would allow 33.4% of UPPs to avoid FOP labeling, compared to 18.4% in Chile and only 2.3% under PAHO standards.

Global Trends

  • Adoption: Over 40 countries have implemented easy-to-understand FOP nutrition labeling systems. This has led to reduced consumer dietary intake of selected labelled nutrients.
  • Variety: Different countries use various systems, such as “excess sugar” stop signs in Mexico, the Nutri-Score system in France, and Health Star Ratings in New Zealand.

While the US is moving towards more transparent FOP labeling, its proposed regulations appear to be less stringent than those in some other countries, particularly in identifying ultra-processed products. The approach differs from the EU’s color-coded system and the more comprehensive labeling requirements seen in countries like Chile.