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Why the Shift to Natural Colors?

For decades, synthetic food dyes have been widely used to enhance the appearance of processed foods. However, growing concerns about potential health risks—such as allergic reactions and behavioral effects—have led regulators and manufacturers to explore natural alternatives.

The Newly Approved Natural Colors

The FDA has granted approval for three new color additives sourced from natural ingredients:

Galdieria Extract Blue – Derived from the unicellular red algae Galdieria sulphuraria, this vibrant blue color is now permitted for use in beverages, dairy products, candies, and frozen desserts.

Butterfly Pea Flower Extract – Extracted from the petals of the butterfly pea plant, this additive provides a range of blue and purple hues for drinks, confections, and dairy-based products.

Calcium Phosphate – A white color additive approved for use in ready-to-eat chicken products, candy melts, and sugar coatings.

These approvals expand the options available to food manufacturers seeking natural, FDA-compliant colorants.

Impact on the Food Industry

The transition to natural food colors is expected to reshape product formulations. While synthetic dyes offer bright, stable colors, natural alternatives may require adjustments in processing and packaging to maintain vibrancy. Additionally, sourcing natural pigments can be more expensive, potentially influencing product pricing.

Despite these challenges, many food brands are embracing the shift, recognizing the consumer demand for cleaner labels and health-conscious choices.

Looking Ahead

The FDA’s approval of these natural colors is part of a broader movement toward reducing synthetic additives in the food supply. As research continues, more natural colorants may emerge, further expanding options for manufacturers and consumers alike.

Dietary supplements are products intended to supplement the diet and provide nutrients that may be missing or insufficient in one’s regular diet. They can come in various forms, such as vitamins, minerals, herbs, botanicals, amino acids, and enzymes.

The regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act (DSHEA), passed in 1994. DSHEA defines dietary supplements and outlines the responsibilities of manufacturers, distributors, and the FDA in ensuring their safety.

The FDA plays a crucial role in overseeing dietary supplements to protect public health. While DSHEA allows supplements to be marketed without FDA pre-approval, the agency still enforces specific regulations to ensure product safety, proper labeling, and appropriate marketing claims.

In the next blogs, we’ll dive deeper into key FDA regulations for dietary supplements, understanding claims and marketing practices, and more. Stay tuned!

An AV Preeminent-Rated attorney, she represents startups to Fortune 500 companies.

Lisa Capote has been honored as one of Florida Trend’s Legal Elite Up and Comers for 2018. Visit Florida Trend’s Legal Elite Digital Edition for a full list of the awardees.

Los granos de café en la determinación final se producen a partir de granos de café verde crudo importados a Canadá o a los Estados Unidos en su estado natural. Una vez en Canadá o en los Estados Unidos, los frijoles se tuestan y envasan. La CBP dictaminó que “tostar granos de café verde transforma sustancialmente los granos en un nuevo y diferente artículo de comercio”. La agencia emite resoluciones de país de origen “con el propósito de otorgar exenciones de ciertas restricciones de ‘Compre estadounidense’ en las leyes de los Estados Unidos o práctica “para la contratación pública.

Once in Canada or the US the beans are roasted and packaged. CBP ruled that “roasting green coffee beans substantially transforms the beans into a new and different article of commerce.” The agency issues country-of-origin rulings “for the purpose of granting waivers of certain ‘Buy American’ restrictions in United States law or practice” for government procurement.

Being issued a warning letter is stressful, but when you take the right steps, it can be far from detrimental.

Identify What Issues the FDA Has with Your Product

An FDA warning letter gives detail about alleged violations your company has made regarding your product(s), your marketing, your product label(s), etc. The first step to handling a warning letter is to break it down and determine what exactly your alleged violations were.

Determine What Needs to Change to Meet FDA Regulations

Sooner rather than later, you’ll need to hold a meeting with any key players in your business to determine what might need to change about the design or manufacture of your product, the marketing of your product, or anything else the FDA stated was violated in the warning letter. Some of these things could be simple changes like updating a label, while others could take time and resources. You’ll need to have an idea of exactly what it will take to meet regulations.

Write a Response to The Warning Letter

Once you’ve identified what you plan to do to satisfy the requirements set forth by the FDA, you’ll need to craft a well-thought-out response. Generally speaking, the more comprehensive the response, the more you’ll illustrate that your company is taking the FDA’s concerns seriously.

You want to avoid being confrontational in the letter and be sure to address each point of contention with an appropriate response about what you plan to change, how long it will take, and what additional steps you may be taking to resolve the issue. Often, a warning letter response requires the help of an experienced FDA lawyer.

Be Ready for A Follow-Up

Be prepared for a follow-up inspection by the FDA to ensure that you have indeed made the changes necessary to meet FDA regulations. Stick to the time frame you provided to them in your response and make sure to have any and all changes completed by that time.

Contact Us Today

If you received an FDA warning letter, don’t wait to take action. Get legal help today by calling our office.

The presence of Sildenafil, Tadalafil, and or Desmethyl Carbodenafil in Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000, and Grande X 5800, renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. For more information visit FDA’s website

In a Similar Recall:

Natures Supplement, Inc. is voluntarily recalling 260 bottles of VEGETABLE VIGRA, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sildenafil. Sildenafil is an FDA-approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy have not been established, therefore subject to recall.

Risk Statement: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that are taken with these products could lower blood pressure to dangerous levels that could be life-threatening. To date, Natures Supplement, Inc. has not received any reports of adverse events related to this recall. For more information visit FDA’s website.

Certain requirements must be met in order to claim that your product is indeed organic. This is also true to put a USDA Organic label on your product. Here’s what you should know.

Does Your Product Need to Be Certified Organic?

If you sell a food product with organic ingredients, you may wonder if your product needs to be certified. In most cases, yes. If your product is not certified, you cannot make any claim that it is organic on the principal display panel. You also cannot use the label of USDA Organic. The only thing you can do to inform consumers that your product contains organic ingredients is to identify which ingredients are organic on the information panel. You may also claim a percent value in relation to how much organic material is used.

Requirements for USDA Organic Labeling

In order to use the USDA Organic label, your food product must meet the following three main requirements:

The product must include only allowed materials and none of the materials that are prohibited for use by the USDA in organic foods.

The product must be grown, manufactured, or produced without any of the methods that are excluded by the USDA for organic products. This includes, but is not limited to the use of sewage sludge, ionizing radiation, or genetically modified or engineered materials.
The production of the food and the final product must be overseen by an agent authorized to approve and certify organic foods by the USDA National Organic Program. The agent must follow all USDA Organic regulations.

How to Ensure USDA Organic Compliance

The above is just a small sampling of requirements that products must meet in order to be considered USDA Organic. Although it is possible to manufacture organic products without certification, doing so makes it difficult to inform consumers that your product is organic. This could lead to decreased sales. If you manufacture an organic food, it’s typically in your best interest to have it certified.

Get help navigating complex USDA regulations for food manufacturing and sales by contacting an experienced attorney. FDAlaw.net can assist you. Call today for a consultation to discuss your food labeling needs.

New Nutrition Labeling Requirements

Increased size font for certain parts of the label. Food manufacturers must now increase the typeface for serving size, number of servings per container, and the number of calories per serving.
Declaration of the amount of certain nutrients. Food manufacturers must now print the actual amount of potassium, calcium, iron, and vitamin D contained in a food product, in addition to the Percent Daily Value.

Declaration of added sugars. Nutrition labels must now include how many grams of added sugars a product contains, as well as the Percent Daily Value.
Some required nutrients are now voluntary. Food manufacturers no longer have to include how much vitamin A and vitamin C is contained in a food product but can do so voluntarily. Other vitamins and minerals besides calcium, potassium, iron, and vitamin D may also be voluntarily included on a product’s nutrition label.

Removal of calories from fat. The FDA once required nutrition labels to list the amount of saturated fat, trans fat, total fat, and calories from fat. However, new labeling requirements no longer include calories from fat.

Changes to serving sizes based on what people actually consume. Some food packaging contains between one and two servings of a food or beverage item. For these packages, the nutrition labels must list the entire contents of the package as a single serving. For example, a bottle of soda may technically be 1.5 servings, but people will usually drink the entire bottle of soda. Therefore, manufacturers must consider how a person will consume the product as packaged and adjust the nutritional facts and serving size accordingly. Some products will need to have a dual nutritional column that lists both the nutritional information for a single serving and the nutritional information for the entire package. For example, a candy bar may be eaten in portions or all at once, and new labeling requirements will allow consumers to better understand what they’re eating or drinking.
Get Help Meeting FDA Nutrition Label Requirements

The new changes to the FDA nutrition label requirements can be confusing for manufacturers. Get help ensuring that your labeling is up to speed by consulting with a seasoned FDA lawyer. Contact FDAlaw.net today for more information by calling.