Can Influencers Be Liable for Promoting Unregistered Health Products?

Introduction

Influencers who endorse cosmetics, supplements, medicines, and other products affecting health may face legal exposure when the products are unregistered, misbranded, deceptively advertised, or promoted without the required regulatory approval. A paid post, product review, livestream, affiliate link, or testimonial may become evidence of participation in a prohibited marketing activity.

The principal risks arise under the Food and Drug Administration Act, the Consumer Act of the Philippines, and related rules on false or misleading advertising. Liability depends on the influencer’s conduct, knowledge, representations, compensation, and degree of participation in the sale or promotion.

What Is an Unregistered Health Product?

Under Republic Act No. 9711, which amended Republic Act No. 3720, health products include products that may affect health and are subject to regulation by the Food and Drug Administration (FDA). These may include drugs, cosmetics, food supplements, devices, biological products, vaccines, in-vitro diagnostic reagents, radiation-emitting devices, and household or urban hazardous substances.

A product generally requires the appropriate FDA authorization before it may be manufactured, imported, sold, distributed, promoted, or advertised. The FDA may also regulate claims concerning a product’s safety, quality, efficacy, therapeutic effect, or health benefit.

In Department of Health v. Philippine Tobacco Institute, Inc., et al., G.R. No. 200431, 2021, the Supreme Court recognized that products may fall within FDA health-product regulation because of their effects on public health. The case also affirmed that FDA authority over health aspects is not automatically displaced by another regulatory statute.

What Conduct May Create Liability?

Section 11 of Republic Act No. 9711 prohibits the manufacture, importation, sale, distribution, promotion, advertising, or sponsorship of a health product that is adulterated, unregistered, or misbranded. It also prohibits the promotion or advertising of a health product that requires registration but has not been registered with the FDA.

The FDA’s regulatory rules likewise prohibit advertising or marketing an unauthorized health product. Claims made in an advertisement must not go beyond the claims appearing on the approved label or packaging, or claims separately approved by the FDA. These standards were discussed by the Supreme Court in Department of Health v. Philippine Tobacco Institute, Inc., et al., G.R. No. 200431, 2021.

An influencer may create legal risk by:

• claiming that an unregistered product cures, prevents, or treats a disease;
• describing a supplement as medically proven without adequate scientific support;
• representing that a cosmetic produces guaranteed or permanent results;
• promoting a product without checking its FDA registration or authorization;
• using a personal testimonial that implies a therapeutic result;
• directing followers to purchase, order, or distribute the product; or
• continuing to promote the product after receiving notice of regulatory violations.

Criminal Risks Under FDA Law

Violations of Section 11 of Republic Act No. 9711 may result in imprisonment of one to ten years, a fine of ₱50,000 to ₱500,000, or both, at the court’s discretion. If the offender is a manufacturer, importer, or distributor, the penalty increases to imprisonment of at least five years but not more than ten years and a fine of ₱500,000 to ₱5 million.

An additional fine of one percent of the economic value or cost of the violative product or violation, or ₱1,000, whichever is higher, may be imposed for each day of continuing violation. The law also permits seizure and custody of violative health products when the FDA Director-General or an authorized FDA officer has reasonable cause to believe that the products may injure or prejudice the consuming public.

For a juridical person, the chairman of the board, president, general manager, partners, or persons directly responsible may be penalized. The statutory penalties and responsible-person provisions are discussed in Venus Commercial Co., Inc. v. Department of Health, et al., G.R. No. 240764, 2021.

An influencer is not automatically treated as a manufacturer, importer, or distributor merely because the influencer publishes a post. However, the risk increases where the influencer is directly involved in selling, receiving orders, collecting payments, maintaining inventory, operating an affiliate system, or acting as the product’s marketing representative.

False and Misleading Advertising

The Consumer Act of the Philippines, Republic Act No. 7394, prohibits false, deceptive, or misleading advertisements. Article 110 covers advertisements that are misleading in a material respect, including advertisements that fail to disclose material facts concerning the consequences of using the product under the stated or customary conditions.

The rule applies not only to statements that are literally false. An advertisement may also be misleading because of its overall impression, the omission of important qualifications, or the way a representation is presented to consumers.

For example, an influencer may create a misleading impression by saying that a supplement is “doctor-approved,” “clinically guaranteed,” or “safe for everyone” when the product lacks the required authorization or when the claim is unsupported. A disclaimer in small print may not cure a prominent and materially deceptive claim.

Under Article 109 of Republic Act No. 7394, the Department of Trade and Industry generally enforces the advertising provisions, while the Department of Health has enforcement responsibility for food, drugs, cosmetics, devices, and hazardous substances. The FDA’s specific authority may also apply where the product is a regulated health product.

Who May Be Held Responsible?

Potentially responsible parties may include the manufacturer, importer, distributor, seller, advertising agency, brand owner, and persons who directly participated in the prohibited promotion. Responsibility is fact-dependent and does not arise solely from the influencer’s popularity.

The following circumstances may be relevant in determining exposure:

• whether the influencer knew or should have known that the product lacked FDA authorization;
• whether the influencer made independent health or therapeutic claims;
• whether the influencer received money, commissions, free products, or other benefits;
• whether the influencer approved the script, caption, images, or product claims;
• whether the influencer helped process sales or recruit buyers; and
• whether the influencer stopped promoting the product after receiving a warning.

The government may pursue the parties directly responsible for the unlawful act. Contractual arrangements between an influencer and a brand do not automatically eliminate liability to consumers or regulatory authorities.

Civil Liability to Consumers

Separate from criminal or administrative sanctions, an influencer and other participants may face civil claims when their representations cause injury, financial loss, or other compensable damage. Possible causes of action may include damages arising from fraud, negligence, breach of consumer-protection duties, or violation of applicable advertising rules.

Under the Consumer Act, manufacturers, producers, importers, and other responsible parties may be liable for defective products or services. An influencer’s civil liability will depend on whether the influencer personally made the representation, assumed responsibility for the product, participated in the transaction, or acted with fraud or negligence.

Consumer claims become stronger where the influencer makes a specific factual representation, knows that the representation is false or unsupported, receives compensation tied to sales, and the consumer relies on the representation and suffers injury or loss.

Can a Paid Disclaimer Avoid Liability?

No. Disclosing that a post is sponsored is important, but sponsorship disclosure does not legalize an unregistered product or validate a false health claim. A disclosure such as “paid partnership” addresses the commercial relationship; it does not establish FDA authorization, scientific support, or product safety.

Similarly, statements such as “results may vary” or “for entertainment purposes only” may not protect an influencer who makes definite and misleading claims elsewhere in the same advertisement. The advertisement is assessed as a whole.

FDA Enforcement and Administrative Measures

The FDA may investigate regulated products, issue cease-and-desist orders, seize products, order recalls or withdrawals, and impose other measures authorized by law and regulation. Under Republic Act No. 9711, a cease-and-desist order for a registered health product is generally valid for 30 days and may be extended for up to 60 days only after due process.

After due process, the FDA may order the ban, recall, or withdrawal of a health product found to have caused death, serious illness, or serious injury, or found to be imminently injurious, unsafe, dangerous, or grossly deceptive.

In Venus Commercial Co., Inc. v. Department of Health, et al., G.R. No. 240764, 2021, the Supreme Court upheld FDA administrative searches and seizures under the FDA statute and recognized the agency’s authority to act against violative health products subject to the statutory safeguards.

Administrative findings supported by substantial evidence are accorded substantial respect by the courts. In Department of Health v. Nestle Philippines, Inc., G.R. No. 244242, 2020, the Supreme Court explained that courts generally defer to administrative findings when supported by relevant evidence that a reasonable mind may accept as adequate.

Important Limits on Agency Regulation

Regulators may enforce the law, but they may not create prohibitions that exceed the authority granted by Congress. In Pharmaceutical and Health Care Association of the Philippines v. Duque, et al., G.R. No. 173034, 2007, the Supreme Court held that an administrative agency cannot expand, amend, or impose restrictions beyond the enabling statute.

This limitation does not permit influencers or brands to disregard valid FDA requirements. It means only that enforcement must remain within the statute, valid regulations, and constitutional safeguards.

Examples of Potential Exposure

Example 1: Unregistered slimming supplement. An influencer receives a commission for every sale and states that the supplement “melts fat without exercise.” If the product is unregistered and the claim is unsupported, the influencer may face regulatory investigation and possible civil or criminal exposure depending on the influencer’s participation and knowledge.

Example 2: Cosmetic with unsupported medical claims. An influencer promotes a cream as a treatment for eczema and infection even though the product is authorized only as a cosmetic. The claim may improperly convert a cosmetic advertisement into a therapeutic representation.

Example 3: Product review without sales involvement. An influencer casually discusses a product but does not sell it, receive compensation, or make a health claim. Liability is less apparent, although exposure may still arise if the influencer knowingly repeats false claims or materially assists the unlawful promotion.

Example 4: Continued promotion after notice. A brand receives an FDA warning, but the influencer continues posting identical advertisements. Continued conduct may strengthen the argument that the influencer acted knowingly or recklessly and may aggravate the regulatory assessment of the campaign.

Compliance Steps for Influencers

1. Verify the product’s FDA registration, notification, license, or other required authorization before accepting a campaign.
2. Request the product’s approved label, packaging, substantiated claims, and advertising clearances.
3. Do not make claims that the product cures, treats, prevents, or diagnoses a disease unless the claim is authorized and adequately supported.
4. Use only advertising language approved by the brand’s legal or regulatory personnel and supported by reliable evidence.
5. Disclose paid partnerships, commissions, free products, and other material connections clearly and prominently.
6. Retain contracts, approval records, product documents, scripts, and communications concerning the campaign.
7. Immediately suspend promotion when the FDA, a consumer, or credible evidence raises a substantial regulatory or safety concern.

Recommendations for Brands and Agencies

Brands and advertising agencies should conduct product verification before engaging influencers. Their agreements should identify who is responsible for regulatory review, require truthful and substantiated claims, prohibit unauthorized edits, and provide a mechanism for immediate removal of noncompliant content.

Campaign monitoring should cover livestreams, comments, affiliate pages, reposts, short-form videos, and consumer responses. A campaign may remain legally problematic even when the original post is deleted if screenshots, recordings, sales records, or other evidence preserve the advertisement.

Conclusion

Influencers are not automatically liable for every regulatory violation committed by a brand. However, they may face serious exposure when they knowingly or negligently promote an unregistered health product, make unsupported therapeutic claims, participate in sales, or continue a campaign after receiving notice of illegality.

The safest approach is to verify FDA authorization, limit claims to approved and substantiated information, disclose commercial relationships, preserve compliance records, and obtain legal review before promoting medicines, supplements, cosmetics, or other products that affect health.

About Nicolas and De Vega Law Offices

 Nicolas and de Vega Law Offices is a full-service law firm in the Philippines.  You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines.  You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com.