Before You Launch

Launching an FDA-regulated consumer product involves considerably more than creating a formula, designing packaging, and placing an order with a manufacturer.

Food, beverage, dietary supplement, and cosmetic companies can encounter regulatory issues involving ingredients, product classification, labeling, claims, manufacturing, registration, safety substantiation, and post-market obligations.

The most expensive regulatory problems are often those discovered after manufacturing or launch.

Before commercialization, companies should ask at least the following questions.

1. How Is the Product Regulated?

The first question is classification.

Is the product a:

• Conventional food;
• Beverage;
• Dietary supplement;
• Cosmetic;
• Drug;
• Medical device; or
• Combination of regulated categories?

Classification determines which statutory and regulatory requirements apply.

2. Are All Ingredients Permitted?

Companies should identify the regulatory status of every ingredient.

For foods, that may require analyzing whether an ingredient is:

• GRAS;
• An approved food additive;
• Subject to another statutory exception; or
• Potentially subject to premarket approval.

For supplements and cosmetics, different regulatory frameworks apply.

3. Does the Product Require a GRAS Analysis?

For substances added to food, companies should determine whether the substance falls within the GRAS exception under Sections 201(s) and 409 of the FD&C Act.

This should be based on the specific intended use—not simply the ingredient’s name. FDA’s August 2026 proposed rule would also potentially change the notification landscape for GRAS substances.

4. Are Color Additives Authorized?

Every color used in a food product should be evaluated under FDA’s color-additive framework.

Natural origin alone does not necessarily eliminate the need for authorization.

5. Is FDA Registration or Listing Required?

Requirements differ by product category.

For example, MoCRA requires covered cosmetic facilities to register and responsible persons to list covered cosmetic products, subject to applicable exemptions.

Companies should determine their obligations before launch.

6. Is the Label Compliant?

The label should be reviewed for all applicable requirements, including:

• Identity;
• Net quantity;
• Ingredient declaration;
• Nutrition labeling, where applicable;
• Allergen requirements;
• Name and place of business;
• Required warnings;
• Claims; and
• Product-specific requirements.

7. Are the Marketing Claims Permissible?

Words such as:

• Healthy;
• Natural;
• No artificial colors;
• Sugar-free;
• Organic;
• Clean; and
• Free-from claims

may require regulatory analysis depending on the product and claim.

8. Could a Marketing Claim Turn the Product Into a Drug?

This is particularly important for supplements, foods, beverages, cosmetics, and wellness products.

A disease-related claim may affect intended use and therefore regulatory classification.

FDA’s online advisory-letter program illustrates the continuing importance of this issue.

9. Are Website and Social-Media Claims Consistent?

The package may be compliant while the website is not.

Companies should review:

• Product pages;
• Testimonials;
• Influencer content;
• Blogs;
• FAQs;
• Paid advertisements;
• Retailer listings; and
• Social media.

10. Are Supplier Documents Adequate?

Companies should understand what their suppliers are actually representing.

Supplier documentation may need to address:

• Specifications;
• Identity;
• Purity;
• Manufacturing;
• Regulatory status;
• Testing; and
• Applicable certifications.

A contract manufacturer’s assurances do not necessarily eliminate the brand owner’s regulatory responsibilities.

11. Are Required Warnings and Disclosures Included?

Product-specific warnings can be critical.

Companies should identify all federal requirements applicable to the product and determine whether state-law requirements may create additional obligations.

12. Are Manufacturing and Quality Systems Appropriate?

Companies should understand who manufactures the product, where it is manufactured, applicable quality controls, specifications, testing, and documentation.

A compliant label cannot cure an adulterated product.

13. Is Safety Substantiation Adequate?

This is particularly important for cosmetics following MoCRA.

FDA explains that responsible persons must maintain records supporting adequate safety substantiation, although FDA does not prescribe one universal testing protocol for every cosmetic product.

14. Are Records Sufficient?

Companies should maintain the documentation necessary to support their regulatory position.

If FDA asks:

“Why did you conclude this ingredient was permissible?”

or:

“What evidence supports this claim?”

the company should have a defensible answer.

15. What Happens If FDA Contacts You?

Companies should know in advance:

• Who receives FDA correspondence;
• Who contacts FDA;
• Who preserves records;
• Who evaluates potential violations;
• Who makes recall decisions;
• Who communicates with retailers; and
• Who coordinates outside regulatory counsel.

Waiting until an FDA letter arrives is not the ideal time to build an FDA response protocol.

The Bottom Line

FDA compliance should be built into the product-development process.

The strongest regulatory strategy is often the one that identifies the issue before the formula, label, manufacturing order, and marketing campaign are finalized.

Garg Law works with consumer brands throughout the product lifecycle—from regulatory strategy and formulation through labeling, claims, commercialization, and FDA enforcement matters. Contact us at info@garg-law.com for questions or to learn more.