FDA Warning Letters Can Cause Cosmetic Companies to Lose Revenue and Face Substantial Fines

The Food and Drug Administration (FDA) issues warning letters for numerous reasons – most based on some violation of the Food, Drug, and Cosmetic Act. Some of the cosmetic products that have been the subject of FDA warning letters include: products for treating acne, removing wrinkles, treating dandruff, restoring hair, growing eyelashes, and reducing cellulite.

Note: we are not making any claims or comments any line of products or individual product, nor do we express any legal opinion about any product; rather, this blog post is merely showcasing some of FDA’s rules and legal actions with respect to cosmetics and other products.

The FDA will conduct its examination into possible FDA violations of cosmetic laws and regulations by:

• Examining a company’s physical plant
• Examining the marketing brochures
• Studying the product labels
• Reviewing the company website

When the FDA does issue a warning letter, there is normally little time, generally a few weeks, before more serious action will be taken. The FDA may impose fines, seek an order to cease production. They may even file a criminal complaint.

The best course of action for any cosmetic company is to take proactive action and speak with an experienced FDA cosmetics lawyer before the FDA issues a warning letter.

Definitions of cosmetics, drugs, and medical devices

Cosmetics

The FD&C Act defines a cosmetic as:

“…(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” [FD&C Act, section 201(i)]

Drugs

Generally, the FDA examines cosmetics to determine if they are drugs or new drugs. Drugs include products that are intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body. If the drug is not generally recognized by qualified experts as safe and effective when used as labeled, it is a “new drug.”

Medical devices

Cosmetic devices can also be challenged by the FDA on the basis that the cosmetic is a medical device. Devices such as injectable fillers, weight reduction, and decorative contact lenses may be intended to help improve someone’s appearance. But the fact that they are intended to diagnose or treat a medical condition or affect the structure or function of the body makes them medical devices under the Federal Food, Drug, & Cosmetic Act (FD&C Act).

The FD&C Act does not require clearance or approval to market cosmetics. The Agency does require clearance and approval to market medical devices. Unlike cosmetics, medical devices are subject to Quality System Regulation.  This can involve fairly burdensome regulation.  Although, there are some carveouts for “general wellness devices.”

Dietary supplements

Dietary supplements are regulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Dietary supplements and ingredients cannot be misbranded or adulterated. Firms must evaluate the product’s safety and labeling before marketing to make sure they comply with the DSHEA and with the FDA regulations. Dietary supplements also must meet Current Good Manufacturing Practices.

The best way to defend—or more likely response to–an FDA warning letter is to review that FDA warning letter with an experienced FDA and FTC attorney; then again, prevention is the best legal medicine.  Consult your FDA law firm that understands FDA cosmetics law, to determine what types of complaints and violations the FDA can assert against a cosmetic maker. If the problems are understood in advance, marketing is thoroughly reviewed, industry-standard manufacturing protocols are established, other measures are taken – the risk of an FDA warning letter can be reduced.

In one case, an FDA warning letter against a cosmetics company, indicates the range of problems that an FDA warning letter may raise. Warning letters are generally made public, and we picked this from among many warning letters

The FDA warning letter

On May 17, 2018, the US FDA sent a letter to the president and vice-president advising them that the company was in violation of the Federal Food, Drug, and Cosmetic Act and relevant regulations. They were advised that any introduction or delivery of their products in interstate commerce would also violate the act. The violations centered around an inspection of the company and a review of the website, cosmetic product labels, and marketing materials.

The main concern the FDA raised was that the company marketing indicates that the cosmetics products were intended to be used as drugs. Drugs must be properly identified and must comply with the relevant drug laws and regulations of the FDA.

The evidence of improper labeling and marketing included citing samples of improper cosmetic/drug marketing including saying the various products sanitize or are named “hand sanitizers.”

Product label and website flags

The FDA flagged numerous assertions that the following benefits (on product labels or the website) for the following products were therapeutic and more than just helping to approve a person’s appearance:

• “Natural Antiseptic . . .• Anti-cavity • Anti-gingivitis • Anti-plaque • Reduces tartar buildup . . . • Soothes toothaches, irritated gums & inflammation . . .”
• “Helps to reduce inflammation & minimize breakouts. . . Beneficial for acne, cuts, burns & rashes. . ..”
• “Promote healthy circulation. . .Improves blood flow • Stimulated hair growth • Relieves dry, itchy scalp. . .revitalize the scalp. . .”
• “For: Allergies, stuffy nose, sinus infections or irritated sinuses. . .”
• “Protect from Bacteria and Infection. . .”
• “Reduce Pain, Inflammation, Scarring and Scar Tissue. . .”
• “Stimulate Production of Stem Cells. . .”
• “Rebuild Damaged Tissue. . .”
• “Uses: Abrasions, Acne, Bites, Blisters, Boils, Burns, Cold Sores . . . Diseased Skin . . . Germ Protection, Infections (Bacterial, Fungal, Viral or Parasitic), Inflammation, Irritations, Itching, Rashes, Skin Conditions, Sores, Sunburn, Post Surgical, Topical Antibiotic, Ulcers, Warts, Wounds, etc. . .”
• Product label – “First sign of Illness. . .”
• “Keep on hand for illness or injury. . .”

Additional label comments that imply the product is a drug include:

• “Effective against the causes of disease. . .”
• “It is the most powerful and safest broad-spectrum antibiotic alternative known to man. . .”
• “REAL RESULTS”

Some testimonials also crossed the line from cosmetic benefits to drug benefits

Examples included:

• “…has been very effective when wiping away my seasonal allergies. Every morning I would wake up with swollen eyes and itchy face and wonder what I could do to make this stop. A couple sips of … eliminated most of the itching. . .”
• “I have COPD and when I over exert myself, I contract bronchitis that usually lasts about three weeks. I started taking … about a month ago and not only has my everyday coughing deteriorated, I have also found that if I feel a bout of bronchitis coming on, I double up on my dose taking it in the am and pm, and within a day the congestion has broken up and my coughing subsides.”

 The webpages including the following drug benefit claims

• “Colloidal silver is highly anti-viral”. In laboratory tests we found that “all fungus, virus, bacterium, streptococcus, staphylococcus, and other pathogenic organisms are killed in three or four minutes. In fact, there is no microbe known that is not killed by colloidal silver in six minutes or less in a dilution as little as five parts per million.”
• “Administer silver nitrate to the eyes of newborns, virtually eliminating the incidence of disease which caused blindness. . .”
• Use for food poisoning, ulcers, parasitic, fungal & bacterial infection. . . Once inflammation has reduced and the symptoms have cleared. . . Use for relief from sinus infection, congestion, allergies, irritated and dry sinuses. . . Warts. . .”

Promotional brochure

• “It is used across the globe as a preventative supplement as well as an aide in healing infections. . . used to aid wound healing. . .sutures to prevent infection in post-surgery events. . .Silver is …effective against a wide range of pathogens. . . “

Why the company advertising violated the Food, Drug, and Cosmetic Act laws

The FDA then proceeded to identity why these medicinal benefit claims violated the FDA laws and regulations:

• New drugs. The products are “new drugs” because they are “not generally recognized as safe and effective for the referenced uses” New drugs require “prior approval” before they can be placed into interstate commerce. Approval requires scientific data and information demonstrating that the drug is safe and effective.
• Misbranding. Drugs are misbranded if they fail to have adequate directions for the intended use. “Prescription drugs, [as defined by the FDA law] can only be used safely at the direction, and under the supervision, of a licensed practitioner. The FDA complained that many of the company’s products “are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner; therefore, adequate directions for use cannot be written so that a layperson can use your products safely for their intended purposes.
• Unapproved New Animal Drugs (Unsafe and Adulterated]. “Moreover, your website and promotional brochures indicate your brand Immune Support and Protection products are also intended for use in the cure, mitigation, treatment, or prevention of diseases in animals.”
• Dietary Supplement CGMP Violations. Putting aside therapeutic and misbranding claims, many of the listed products listed on the FDA warning letter would still be adulterated dietary supplements within the meaning of law because the products have been manufactured under conditions that do not meet the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation in Title 21, Code of Federal Regulations, Part 111 (21 CFR part 111).

CGMP violations include, according to the FDA warning letter:

• • Failing to address quality control operations in writing and according to specific procedures
  • Failing to address quality control issues and specifications in the manufacturing process such as establishing:
    • “Specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).”
    • “Specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d).”
    • “Specifications for each dietary supplement product you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).”
    • “Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).”
    • Failing to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
    • Numerous other CGMP violations

• Misbranding Dietary Supplements. The FDA warning letter also stated that the company was in violation of FDA law and regulations because many of the products were “misbranded” because:
  • The nutrition information on the label didn’t comply with the regulations because some weights were listed under the wrong heading and in inaccurate columns.
  • Serving sizes were incorrect or weren’t placed on the labels
  • The labels didn’t have a domestic address or domestic phone number to report serious adverse events
  • The labels fail to list the name and place of business of the manufacturer, packer, or distributor

The FDA stated that there may be additional violations. The company was informed it needed to take prompt action to correct all the listed violations. Prompt action means providing the FDA specific steps the company will take to correct each violation and to prevent future violations. The company was given 15 days to respond.

The FDA further informed the company that the FDA could assess fees to cover the agency’s costs including the cost of re-inspections.

Cosmetic companies need to understand that the FDA will examine if their products are essentially drugs or dietary supplements and they will examine every product label in detail. FDA will study each and every page and each and every posting on your company website. The Agency will examine all marketing materials. The FDA will also inspect your manufacturing process in person. FDA will also review whether the cosmetic is a medical device. They will examine if the cosmetics are adulterated such as if it contains a microbial contamination which may be considered poisonous or a deleterious substance.

Experienced FDA attorneys understand why FDA warning letters are issued to cosmetic manufacturers. Skilled FDA cosmetic lawyers help businesses develop protocols to minimize the risk of warning label. We can assist you in reviewing your manufacturing process, labels, and marketing. If a warning letter is issued, we will help you respond to such letter.

Contact our FDA warning letter lawyers at Cohen Healthcare Law Group, PC for help before and after the FDA warning letter arrives.  An ounce of legal prevention is worth a pound of cure.