FDA Issues Archives - Page 3 of 32 - Customs & International Trade Law Firm

Five Tips for SMEs Looking to Scale Wellness Brands in the US
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Five Tips for SMEs Looking to Scale Wellness Brands in the US
Best Practices, Import Alert, International Business, International Trade, Labeling, Pre-compliance

Five Tips for SMEs Looking to Scale Wellness Brands in the US

DTL President Jennifer Diaz was featured in Santander Navigator! Read below or on Santander here.

Pre-planning and investing in regulatory compliance measures are key to success

The US is the most lucrative wellness market in the world – and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore.

And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to research by the Global Wellness Institute.

In contrast, China’s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn.

However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance.

Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA’s blacklist.

1. Know the regulators

One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says.

Companies also need to designate […]

By Jennifer Diaz|2025-06-17T08:01:40-04:00June 17, 2025|Best Practices, Import Alert, International Business, International Trade, Labeling, Pre-compliance|0 Comments

MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings
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MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings
Cosmetics, U.S. Food and Drug Administration (FDA)

MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings

The U.S. Food and Drug Administration (FDA) has released summary data from mandatory registration of cosmetic product facilities and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA Background & Requirements

MoCRA was passed in 2022 in an effort to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.

MoCRA Requirements:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety substantiation
Compliance with Good Manufacturing Practices (GMPs)
Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority.

The FDA has issued guidance providing recommendations to assist companies in complying with the law. In addition, the agency developed a new online tool – Cosmetics Direct – dedicated exclusively to product facility registration and cosmetic product listing submissions.

New Data

As of January 1, 2025, the number of unique, active facility registrations is 9,528 and the number of unique, active product listings is 589,762.

The top five states for number of domestic registered facilities are:

California (373)
Florida (201)
New Jersey (144)
Texas (120)
New York (118)

The top five countries for foreign registered facilities are:

China (4,260)
South Korea (617)
India […]

By Jennifer Diaz|2025-03-26T16:28:22-04:00March 26, 2025|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
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FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
Food, U.S. Food and Drug Administration (FDA)

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

The U.S. Food and Drug Administration (FDA) issued a proposed rule that would require a front-of-package (FOP) nutrition label on most packaged foods.

Rule Details

The label, referred to as the “Nutrition Info Box,” must contain the amounts (per serving) of three nutrients:

Saturated fat
Sodium
Added sugar

The label must also list whether the amount of these ingredients per serving is “Low,” “Med,” or “High.”

The FDA is proposing a compliance date of three years after the final rule’s effective date for businesses with $10 million or more in annual food sales. Businesses with less than $10 million in annual food sales would have four years to comply.

FDA Intent

The FDA stated that the Nutrition Info Box would complement the Nutrition Facts label that is already required on most packaged food. While the Nutrition Facts label is helpful to many consumers, the FDA found that some segments of the population do not regularly read the label.

Therefore, this rule is intended to provide accessible, at-a-glance information to help consumers quickly and easily identify how foods can be part of a healthy diet.

The agency conducted a literature review that included focus group testing and a peer-reviewed experimental study to explore consumer reactions and responses to various FOP nutrition labels.

The results indicated that interpretive FOP nutrition information is helpful for consumers and easy to understand.

Input on the Rule

The FDA is currently seeking public input on the proposed rule. The deadline to submit comments is May 16, 2025. If you will be impacted by the new requirements, […]

By Jennifer Diaz|2025-01-17T15:57:40-05:00January 17, 2025|Food, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
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FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
FDA Issues, Food, U.S. Food and Drug Administration (FDA)

FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling

On December 19, 2024, the FDA announced a final rule to update the criteria that food must meet to qualify for use of the claim “healthy”.

New Requirements

To meet the updated criteria, a food product needs to:

Contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and
Meet specific limits for added sugars, saturated fat and sodium.

The criteria vary for individual food products.

Under the new rule, nutrient-dense foods that are encouraged by the Dietary Guidelines with no added ingredients automatically qualify for the “healthy” claim. These include:

Vegetables
Fruits
Whole grains
Fat-free and low-fat dairy
Lean game meat
Seafood
Eggs
Beans
Peas
Lentils
Nuts
Seeds

Products that do not qualify for the healthy label under the updated rule include:

Fortified white bread
Highly sweetened yogurt
Highly sweetened cereal

These changes reflect current nutrition science and dietary guidance in the Dietary Guidelines for Americans.

What Food Manufacturers Should Do

The rule is effective February 25, 2025, and the compliance date of the rule is February 25, 2028. In preparation for the compliance date, food manufacturers should review their products to ensure that any product that uses a “healthy” label meets the new criteria. Diaz Trade Law has subject matter FDA expertise and can help you with a proactive compliance plan that meets the new requirements.

Updated “Healthy” Claim Factsheet
Webinar: Importing Food in Compliance With […]

By Jennifer Diaz|2025-01-10T09:59:17-05:00January 10, 2025|FDA Issues, Food, U.S. Food and Drug Administration (FDA)|0 Comments

MoCRA Enforcement is Right Around the Corner! Are You Ready?

The Food and Drug Administration (FDA) is set to start enforcing the requirements of the Modernization of Cosmetics Regulation Act (MoCRA) on July 1, 2024. Manufacturers, distributors, or packers of cosmetic products must comply with the requirements to avoid an enforcement action.

MoCRA Background

In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety.

MoCRA was passed in 2022 and aims to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.

Subsequent to the bill’s passage, the FDA issued regulations implementing the law. In issuing MoCRA regulations, FDA’s aim was to help ensure the overall safety of cosmetic products, and expand the Agency’s ability to trace and track non-compliant products and facilities. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA impact the entire lifecycle of cosmetics products from manufacturing to marketing.

MoCRA Requirements

New MoCRA requirements include:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety […]

By Jennifer Diaz|2024-06-11T09:59:49-04:00June 11, 2024|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

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