Is Recell Coffee FDA Approved? The Truth About Its Safety

January 10, 2026 •

3 min read

In December 2024, the Philippine Food and Drug Administration (FDA) issued a public health warning against the purchase and consumption of Recell Stemcell Coffee Caramel Macchiato. This official warning explicitly states that the product is unregistered and has not undergone the necessary evaluation process to ensure its quality and safety.

Quick Summary

A public health warning has been issued against Recell Stemcell Coffee Caramel Macchiato by the Philippine FDA due to its unregistered status. The agency cannot assure the product's quality and safety, advising against its purchase or consumption. This article provides key details on the advisory and why regulatory status matters for consumer health.

Key Points

Not FDA Approved: The Philippine FDA issued a public health warning against Recell Stemcell Coffee Caramel Macchiato, stating it is an unregistered food product.
Unregistered and Unevaluated: The product has not undergone the mandatory evaluation process by the FDA, so its quality and safety are not assured.
Misleading Claims: Marketing terms like "stemcell coffee" are not backed by scientific fact and are often used to make unsubstantiated health claims.
Potential Health Risks: Because it is unregulated, Recell Coffee may contain contaminants, undeclared ingredients, or misleading potencies, posing a risk to consumer health.
Check FDA Verification Portal: Consumers should always verify the registration status of a food product using official FDA portals to ensure their safety.
Distribute and Sell Prohibited: The FDA advisory warns against the distribution, advertisement, and sale of this unregistered product.

Recell Coffee: The Lack of FDA Approval

The Philippine FDA has issued a public health warning against Recell Stemcell Coffee Caramel Macchiato, stating it is unregistered and its quality and safety cannot be assured. This means the product has not undergone the required evaluation process for legal sale and consumption.

The Misleading Nature of 'Stemcell Coffee' Claims

Marketing terms like "Stemcell Coffee" for products like Recell Coffee are misleading. Similar to advisories from other health authorities, claims of supplements containing 'live stem cells' or offering miraculous cures are scientifically unsubstantiated. The FDA evaluates products based on ingredients and process, not unproven marketing.

What the Public Health Warning Entails

The FDA advisory confirms the lack of a Certificate of Product Registration (CPR) for Recell Stemcell Coffee Caramel Macchiato. This poses potential health risks as safety and quality haven't been evaluated. The advisory prohibits the product's distribution, advertisement, and sale, and advises the public against purchase or consumption. Law enforcement is also involved to ensure the product is not available.

The FDA Approval Process for Food vs. Drugs

The FDA's regulatory process differs for food and drugs. While drugs need pre-market approval with trials, most food, including coffee, does not require the same level of approval. However, food manufacturers must still ensure safety and accurate labeling, and the FDA can act against unsafe products.

How FDA Approval Differs


Feature	Food Products (General)	Drugs (Therapeutic Claims)
Premarket Approval	Generally not required, except for food additives and color additives.	Required, involving extensive clinical trials and data review.
Manufacturer Responsibility	Manufacturers must ensure safety and accurate labeling, adhering to regulations like FSMA and GMP.	Manufacturers must prove the product's safety and efficacy to the FDA.
Regulatory Action	FDA can take action against unsafe products, mislabeling, or unproven claims.	FDA approval allows marketing; marketing without approval is prohibited.
Labeling	Must be truthful and not misleading. Ingredients and allergens must be declared.	Must be FDA-approved and clearly state indications, warnings, and dosage.
FDA Monitoring	Monitors the market and conducts facility inspections.	Continuous post-market surveillance for safety and efficacy.

The Importance of a Certificate of Product Registration (CPR)

A CPR signifies that a product has been evaluated by the FDA and is considered safe for public use. Recell Coffee's lack of a CPR indicates it skipped this crucial evaluation, failing to meet regulatory standards designed for consumer protection. Unregistered products are illegal and potentially hazardous.

Potential Health Risks of Unregistered Supplements

Unregistered food products and supplements carry risks. These include potential contamination due to lack of sanitary oversight, adulteration with undeclared harmful substances or prescription drugs, misleading potency or dosage, lack of scientifically-backed efficacy for health claims, and dangerous interactions with medications from undeclared ingredients.

Conclusion: Consumer Due Diligence is Paramount

Recell Coffee is not FDA approved. The Philippine FDA has issued a public health warning against Recell Stemcell Coffee Caramel Macchiato due to its unregistered status, meaning its safety and quality are not evaluated. Consumers should avoid this product and always check for proper regulatory approval before using any food supplement. The FDA Verification Portal can be used to confirm a product's authorization.

Frequently Asked Questions

No, according to the Philippine FDA, it is illegal to manufacture, sell, import, or distribute Recell Stemcell Coffee Caramel Macchiato because it is an unregistered product.

An FDA-approved or registered product has undergone the necessary evaluation process to ensure its quality and safety, while an unregistered one has not and its safety is not assured by the regulatory body.

Most conventional coffee does not require 'approval' in the same way drugs do. However, any flavored coffee, and especially those making therapeutic-sounding claims, must be properly registered and adhere to FDA regulations regarding ingredients and labeling.

Risks include potential contamination, the presence of undeclared and harmful ingredients, inaccurate potency, and false health claims, all of which could lead to adverse health effects.

Consumers can check the registration status of products using the official FDA Verification Portal.

The advisory was issued because post-marketing surveillance revealed that Recell Stemcell Coffee Caramel Macchiato was being sold despite not being registered with the agency.

The specific advisory references "Recell Stemcell Coffee Caramel Macchiato". However, any product with therapeutic-sounding claims should be verified, as a separate FDA found other Recell products, such as a capsule, were high-risk food products.