How to Respond to an FDA Warning Letter about Dietary Supplements or Cosmetics

The United States Food and Drug Administration (FDA) regulates much more than food and drugs. It regulates dietary supplements, cosmetics, medical devices, tobacco products, animal food, vaccines, and many other health related items.

The categories of FDA regulations include:

• Approving ingredients
• Mandatory labeling requirements
• False labeling
• Misbranding
• Proper manufacturing processes

Companies that make, sell, and market should review their compliance requirements with an experienced FDA lawyer before they start their operations. The attorney will explain which laws and FDA regulations apply and what steps must be taken to prove compliance. The company will need to meet with a respected FDA attorney if they receive a warning letter. If a business fails to give a proper response to the warning letter, it may be forced to close down and stop operations, or at least, to stop, marketing some of their products.

What are FDA Warning Letters?

The FDA can send a warning letter after they've conducted a visual inspection of your property and/or physical plant, conducted chemical tests on your products, reviewed your marketing materials and website, or for other reasons. An FDA warning letter is basically an instruction to cease and desist whatever conduct the FDA thinks is necessary until you can show compliance with FDA regulations. The letter does give you a limited time reply before you must formally stop. Many times, if your company works with a reputable FDA warning letter attorney, the company can continue operations either immediately or after some reasonable adjustments are made

The FDA warning letter should specifically detail the alleged violations by indicating which laws it thinks you violated and what the nature of the violation was. An FDA healthcare lawyer will explain what the violations mean and what corrective measures must be taken. Generally, the company and FDA warning label attorney will craft a response that shows you're taking the warning seriously, and that you're addressing each violation thoroughly. The reply can indicate that you may need time to implement corrective measures providing you spell out the steps and the anticipated timeline.

The company should anticipate that the FDA will conduct a follow-up inspection, lab tests, and reviews to show that you are working towards compliance.

For example, The FDA may send a letter that a manufacturer or retailer is misbranding their products as cosmetics when they are really drugs – in violation of the Food, Drug and Cosmetic Act. The violations can be more precise too such as failing to include a domestic address for reporting adverse consequences or failing to provide a 'Supplemental Facts' label.

There is a short timeline for responding to an FDA warning letter – 15 days. If you fail to respond, the FDA may issue a recall, may seize some of your products, may issue an injunction to stop further manufacture or sale of the product, and may prevent its entry into America.

What are dietary supplements

The dietary supplement industry is multi-billion-dollar industry The FDA regulates dietary supplements so consumers can be confident that the products they consume are safe and of good quality. While many dietary supplements such as Vitamin D and iron are often recommended by physicians, some supplements have no medical benefit.

The attorney will begin the review of an FDA warning about dietary supplements by examining whether your products meeting the DSHEA definition of dietary supplement. Generally, a product is a 'dietary supplement' if:

• It is taken orally
• Is intended to supplement the user's diet
• It contains specific ingredients such as vitamins, minerals, herbs or other substances

Dietary supplements must be labeled as dietary supplements. They cannot be labeled or represented as the sole item of a meal or that they can be used as conventional food. Generally, products that meet the DHSEA definition of dietary supplement don't need FDA pre-approval – unless they also meet the definition of drug as defined by the Food, Drug, and Cosmetics Act. It is this cross-over definition – where a product is both a dietary supplement and a drug – that prompts may FDA warning letters.

The FDA must be notified if a dietary supplement includes a new dietary ingredient (NDI) that was not on the U.S. market before Oct. 15, 1994

Some of the laws that dietary supplement companies should review with legal counsel are:

• The Dietary Health Safety and Education Act of 1994 ('DSHEA')
• The Food, Drug & Cosmetic Act ('FDCA')
• The Nutrition Labeling and Education Act of 1990
• The Fair Packaging and Labeling Act

FDA warning letters based on invalid claims (misbranding)

Dietary claims that can be made

A major FDA concern about dietary supplements is that while companies can make claims about the structure and function of the products, the company can't make other types of claims. Though the FDA doesn't need to pre-approve structure/function claims, the manufacturer should be able to verify its claims and does need to submit it claims for FDA approval within 30 days after the product is marketed.

Structure/function claims generally involve statements about how the product affects the body or someone's general well-being – such as fiber can help manage a person's metabolism or calcium is good for your bones.

Dietary claims that cannot be made

• Health and disease. The company can't make health claims or disease claims – in its advertising, websites, brochures, testimonials, endorsements, and other marketing materials. Health and disease claims do need to be pre-approved by the FDA which requires 'significant scientific agreement,' to support the claim.

Companies need to be careful and review each claim with their attorney. For example, saying that calcium builds strong bones is a structure statement. Saying that calcium can reduce the danger of osteoporosis is a medical claim. Disease claims are statements such as this supplement can reduce the risk of heart disease or shrink a tumor.

• Qualified health claim. There is also a middle ground, called a 'qualified health claim' which don't require significant scientific agreement but still need pre-approval from the FDA.
• Nutrients. Nutrient claims, such as that a product is high in vitamin C are limited to those which the FDA authorizes.

FDA warning letters based on invalid labeling

Companies must be very careful how they label their dietary supplements. They can't misinform the public.

The FDA provides a dietary labeling supplement guide that covers such issues as:

• General Dietary Supplement Labeling
• Identity Statement
• Net Quantity of Contents
• Nutrition Labeling
• Ingredient Labeling
• Claims
• Pre-market Notification of New Dietary Ingredients
• Other Labeling Information

Your FDA warning lawyer will review numerous questions for each labeling category. They must follow very precise labeling requirements that cover such issues are:

• What label statements are required?
• Where does the company need to place the label and the principal design panel?
• What label statements must be put on the principal design panel?
• What label statements must be on the information panel?
• What name and address must be placed on the product label?
• What type size, conspicuousness, and other factors must be on both the principal display panel and information panel?
• If the product is not made in the U.S., does the manufacturer need to specify the product's country of origin?

For the identity statement labeling requirement the attorney will explain:

• What an identity statement is for dietary supplements and where the identity statement should be placed
• How prominent the identity statement should be
• Is it OK to place the identity statement on the principal display panel?

FDA warning letters based on failure to maintain current good manufacturing practices

The FDA generally expects the makers suppliers, and producers of dietary supplements will ensure that they are meeting current good manufacturing practices (cGMPs). If the supplements have nonapproved ingredients, the incorrect amount of ingredients, or contaminants; the FDA may issue a warning letter questioning the company cGMPS.

Cosmetics

There are numerous ways an experienced FDA lawyer can help cosmetic product companies avoid FDA enforcement before the warning letter is sent. There are also many ways a trusted FDA warning lawyer can help your company if an FDA letter is sent.

FDA warning letters to cosmetic companies include the FDA position that:

• The cosmetic is a drug because it is meant to help diagnose, treat or prevent a disease. There is often a thin difference between the two. A respected FDA warning lawyer understands the differences. Generally, cosmetics don't need FDA pre-approval while drugs do need pre-approval. The FDA does regulate both cosmetics and drugs.
• The cosmetic is s a new drug which has not approved through the filing of a New Drug Application. Many warning letters fall into this category.
• The company makes claims that the cosmetic acts as a drug – such as being able to treat acne, reduce cellulite, treat dandruff, or other similar health-related claims. Many FDA warnings are issued because the cosmetic company is trying to have the best of both worlds – classification of the product as a cosmetic/not a drug but with the benefits that drugs offers. Companies can't have it both ways.
• The labels are misleading or fail to comply with the strict FDA regulations and other labelling law
• The cosmetic is a medical device, even though it's main aim is to enhance the user's appearance. The company must follow the FDA rules and regulations governing medical devices. Marketing a medical device requires pre-approval by the FDA while marketing cosmetics generally does not (unless other exceptions apply)
• The cosmetic is a color additive

Words such as cosmetics, drugs, new drugs, medical devices, and color additives are legal words of art. An experienced FDA warning letter lawyer will review whether your cosmetic meets these precise legal terms.

Generally, a cosmetic is designed to make the user feel more attractive provided they don't change how the skin or another body part functions.

Conclusion

• FDA warnings include misbranding, mislabeling, noncompliance with quality manufacturing procedures, and other violations of FDA rules
• There's often a thin line between compliance and noncompliance
• There are often practical solutions that help your comply respond to the warning and continue in business

Talk to a respected FDA Warning Lawyer Today

Companies must move quickly to review an FDA warning letter with legal counsel. The normal response time is 15 days. To understand why the FDA has determined that you violated the law or regulations and what you must do defend your business practices or how to adjust them, Contact Cohen Healthcare Law Group. Our FDA and FTC lawyers are experienced FDA warning lawyers with a strong record of legal advocacy.