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Cosmetics

5 Reasons FDA Will Detain Imports of Holistic Products

Products marketed as “holistic” have become increasingly popular in the United States. With more people aiming to incorporate natural products into their lifestyle, companies are striving to meet the demand. Holistic products come in many forms, from detox teas and skin creams to dietary supplements and weight-loss pills.

FDA does not regulate the use of the term “holistic”. It is largely a marketing term intended to signify a natural product manufactured with minimal processing. Although FDA does not regulate the term, products marketed as holistic are subject to the same FDA regulations as other products. If you are shipping a holistic product to the U.S., complying with FDA’s regulations can help prevent costly detentions.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at [email protected], or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

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Keep reading for compliance issues to avoid when preparing products marketed as holistic.

Unauthorized Health Claims

Consumers often purchase holistic products believing the products can reduce the risk of disease or a health-related condition. However, to market health claims on food or dietary supplement labels, establishments must prove to FDA that the health claims are substantiated. If a product bears labeling with health claims that FDA has not authorized, the product may be detained for misbranding or adulteration.

FDA may authorize a health claim if scientific evidence exists that validates the correlation between the substance and the health-related condition. Once authorized, FDA codifies it in regulation, and any product that meets the conditions may use the claim. If a claim has not been authorized, a petition must be filed with FDA. Any interested person may petition FDA to issue a regulation to authorize a specific health claim. Qualified experts review the petition and must reach an agreement that all publicly available scientific evidence supports the relationship between the health-related condition and the substance.

Missing Statement of Identity

All conventional foods and dietary supplement products must include a statement of identity on the label. For conventional foods, this is usually the “common or usual name” for the product, such as “green tea.” Dietary supplements have a different set of requirements for the statement of identity. FDA and the Federal Food, Drug, and Cosmetic Act require supplements to bear labeling that specifies the statement of identity “dietary supplement” (which may be modified to replace “dietary” with the name of the ingredient(s)). Firms must place the statement of identity on the principal display panel (PDP) of the product and any alternate PDPs. The statement of identity must be in bold print, separate from the brand name, and prominently featured on the label.

Missing “Supplement Facts” Panel

Supplements must bear a Supplement Facts panel that serves as the product’s nutrition label. The Supplement Facts panel must include, among other things, the common names and quantities of dietary ingredients and the serving size of the supplement. The panel must also include servings per container if this information is not conveyed by the net quantity statement.

FDA requires certain nutrients to be listed on the Supplement Facts panel if the amount in the product exceeds established levels of significance. FDA requires that you declare the amounts of 15 established mandatory nutrients (if present) and any other “dietary ingredients” (such as an omega fatty acid) that are present in the product.

Undeclared Ingredients

FDA requires manufacturers to list all ingredients included in a food product on the product’s label. If FDA inspects an imported product and determines that there are undeclared ingredients, FDA may place the product on Import Alert. Products on Import Alert are subject to Detention Without Physical Examination (DWPE) and FDA may refuse entry to the shipments unless the importer can prove that the products do not include undeclared ingredients. Products that are refused entry must be destroyed or re-exported out of the U.S.

Label Not in English

FDA requires that all mandatory words, statements, and other information on labels appear in English. A label may include other languages along with English, but if any of the mandatory labeling information (such as the product name or ingredients list) is present in a foreign language, all of the required information on the label must appear in that language as well.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at [email protected], or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

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More Than 30 Aerosol Hair Products Recalled for Potential Health Risk

Proctor and Gamble (P&G) recently recalled more than 30 aerosol hair products due to the presence of benzene, a chemical that can cause cancer. The affected products include dry shampoos, dry conditioners, and various styling products.

The recall occurs as drafts of the Personal Care Products Safety Act remains with legislative sponsors. If passed, the Act could help prevent companies from marketing cosmetics that contain potentially harmful ingredients by giving the U.S Food and Drug Administration (FDA) authority to regulate cosmetics as it regulates other industries.

Registrar Corp’s services for cosmetic companies

Cosmetic companies that need assistance with FDA requirements can contact Registrar Corp, a leading FDA compliance consultant. Our Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more.

For more information, call us at +1-757-224-0177, email us at [email protected] or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

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Read on for more about P&G’s recall and the impact the Personal Care Products Safety Act would have on the cosmetics industry if passed.

The P&G Recall

On December 17, 2021, P&G announced that it was voluntarily recalling certain dry shampoos and conditioners due to the presence of benzene. Benzene is a human carcinogen that has been linked to cancer upon exposure through inhalation, skin absorption, or oral consumption.

The recall notice identifies affected brands as Pantene, Herbal Essences, Hair Food, Old Spice, and Aussie. This recall follows an earlier recall in November 2021 in which P&G recalled aerosol deodorants and sprays, also in response to the presence of benzene.

The financial and reputational effects of a recall can be extensive for a cosmetics company. For both the November and December recalls, P&G not only ceased manufacturing affected products, but it also instructed consumers who already purchased the products to discard them. The company has also urged retailers to throw affected products away. P&G offered full refunds to customers who submit a refund request.

The Personal Care Products Safety Act

The proposed Personal Care Products Safety Act seeks to give FDA increased regulatory authority over the U.S. cosmetics industry to improve consumer safety. Currently, cosmetics produced in the U.S. are not subject to screening before entering the market. FDA can refuse non-compliant cosmetics at the port of entry. However, given the large number of such imports, potentially unsafe products often enter into the U.S. market. This creates a reactive approach to assessing cosmetics for consumer safety, as opposed to a preventative approach.

If passed, the Act would give FDA the authority to regulate cosmetics through regulatory methods the agency uses for other industries. Increased regulations could help prevent dangerous substances from entering the U.S. cosmetics market. The Act would also give FDA authority to issue mandatory recalls on non-compliant products.

Regulatory procedures the Personal Care Products Safety Act would establish for cosmetic establishments include:

  • Mandatory facility registration and renewal – Facilities that manufacture, process, or (in some cases) distribute cosmetics for use in the United States would be required to register with FDA. Non-U.S. cosmetic facilities would need to designate a U.S. Agent to act as a communications link between FDA and the foreign firm.
  • Good manufacturing practices (GMPs) – The Act would allow FDA to establish GMPs that would provide enforceable standards for FDA to reference during inspections.
  • Reporting serious adverse events – Facilities would need to submit reports of health-related events associated with the use of a cosmetic that result in or require medical intervention. This includes an annual report of rash development occurrences.
  • Cosmetics ingredients statements – Facilities would need to submit a statement to FDA containing, among other requirements, facility information, the cosmetic’s ingredients, and applicable warnings.
  • Ingredient review – FDA would analyze safety data surrounding certain cosmetic ingredients to determine whether they are safe for use without restriction, safe under certain conditions or uses, or not safe for use at all. FDA would have authority to prohibit certain ingredients for use in cosmetics.

The Personal Care Products Safety Act has received bipartisan support and support from several prominent cosmetic companies. Congress has introduced the Act, and it could become law in the coming years.

Registrar Corp’s services for cosmetic companies

Cosmetic companies that need assistance with FDA requirements can contact Registrar Corp, a leading FDA compliance consultant. Our Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more.

For more information, call us at +1-757-224-0177, email us at [email protected] or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

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FDA Upholds Final Rule Removing Lead Acetate From Listing of Color Additives

The U.S. Food and Drug Administration (FDA) will move forward with its repeal of lead acetate from the certified list of color additives in cosmetics intended for coloring hair on the scalp. A stay to the final rule entitled “Termination of Listing of Color Additives Exempt From Certification; Lead Acetate” had been in place in response to hair dye manufacturer Combe Inc.’s objections to the rule.

After evaluating Combe Inc.’s objections and finding no grounds to reverse the ruling, FDA will uphold the amendment of the color additives list to no longer provide for use of lead acetate in hair dyes.

Keep reading to find out what FDA’s repeal of lead acetate from the color additive listing could mean for you.

FDA’s Final Rule on Color Additives

FDA’s final rule, published on October 31, 2018, amended color additive regulations to reflect FDA’s determination that “there is no longer a reasonable certainty that no harm will result” from including lead acetate in cosmetics used to dye the hair and scalp.

In 1980, FDA had deemed lead acetate safe to use in hair dye in certain amounts and within certain parameters. In the final rule, FDA stated its intention to remove lead acetate from the list of certified color additives based on modern research that suggests that previous conclusions about lead acetate’s definite safety are no longer accurate. Currently, FDA concurs with evidence indicating that lead acetate in hair dye is not proven to be safe in any amount.

The Stay on the Rule

The public was able to file objections or requests for a hearing on the final rule until November 30, 2018. Combe Inc. filed 19 objections to the final rule and requested hearings on each objection. The Food, Drugs and Cosmetics (FD&C) Act determines that objections to final rules result in a stay, which remains in place until FDA takes final actions on objections.

FDA analyzed and addressed Combe Inc.’s objections and concluded that the objections “do not raise any genuine and substantial issue of fact that can be resolved by an evidentiary hearing.” FDA denied hearing requests and, as there were no other filed objections, subsequently lifted the stay on the final rule. As of January 6, 2022, FDA will no longer list lead acetate as a color additive in cosmetics intended for coloring hair on the scalp, effectively prohibiting its use in those cosmetic formulations.

FDA will allow the cosmetics manufacturers 12 months to deplete the current supply of hair dye products containing lead acetate and to reformulate their products.

The Personal Care Products Safety Act

FDA’s upholding of the final rule on lead acetate follows a proposal for The Personal Care Products Safety Act. Congress introduced the proposal on June 17, 2021. If passed, the Act will increase FDA’s authority to regulate ingredients in personal care products for safety, enabling the Agency to more proactively oversee such products.

Among other things, the Personal Care Products Safety Act would require personal care product facilities to:

  • Register the facility with FDA and renew registration as required
  • Disclose product ingredients to FDA
  • Report serious adverse effects, such as those requiring medical intervention
  • Adhere to good manufacturing practices (GMPs) for personal care products. The Act will require FDA to establish GMPs for such products.

Though the Act has not yet passed, many elected representatives, as well as cosmetic companies themselves, support the reform. If passed, the Act would create regulations that resemble existing requirements in other FDA-regulated industries.

Registrar Corp’s FDA Compliance Services

Registrar Corp’s Regulatory Specialists can help you stay compliant with FDA color additive requirements, register with FDA, and more. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at https://regstaging.wpengine.com/livechat.

The Future of U.S. Cosmetics Regulations

Updated November 10, 2022

The multi-billion-dollar U.S. cosmetics industry is booming.  The U.S. Food and Drug Administration (FDA), which regulates cosmetics in the United States, reports through its data dashboard that over 3 million cosmetic line-items entered U.S. ports in Fiscal Year (FY) 2021.   However, this immense volume of cosmetic imports poses certain challenges as current regulations and resources limit what the Agency can do to effectively prevent potentially harmful cosmetics from entering U.S. distribution.

It is probable that, in the unexamined shipments, many non-compliant and potentially harmful products evaded enforcement and made their way to shelves.

Sometimes companies will recall these harmful products, but by then, the cosmetics have already fallen into the hands of consumers. In December 2021, Proctor and Gamble (P&G) recalled more than 30 aerosol hair products due to the presence of benzene, a chemical that can cause cancer. More brands initiated recalls for the same reason in the following months. Despite the recalls, independent lab testing performed in October 2022 revealed that 70% of tested dry shampoos still contained benzene.

Solutions For Proactive Regulations

Current FDA regulations for cosmetics are reactive, often addressing compliance issues after a product has already entered U.S. distribution. FDA can issue Warning Letters for non-compliance and refuse cosmetics in port, but the Federal Food, Drug, and Cosmetics (FD&C) Act does not give the Agency authority to order a mandatory recall of a cosmetic.

Other products under FDA’s authority such as food, medical devices, and drugs are more proactively regulated. These products are subject to pre-market submissions and facility requirements that not only help the Agency prevent significantly more non-compliant products from entering the U.S., but also better enforce action against them when they do.

In order to provide comparable regulations for cosmetics, the U.S. Congress  introduced The Personal Care Products Safety Act. This act is not the first of its kind, but similar bills like the FDA Cosmetic Safety and Modernization Act (S.2003) and the recent Safe Cosmetics and Personal Care Products Act of 2018 (H.R.6903) have not made it past Congress committees. They share some commonalties that illustrate the direction U.S. cosmetics regulations may take in the next decade.

In May 2022, FDA released a discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act, which includes steps to strengthen oversight of cosmetics based on provisions laid out in the Personal Care Products Safety Act. This article will discuss major changes industry should expect if the  Personal Care Products Safety Act or a similar bill becomes a law.

Learn about Registrar Corp’s cosmetics services.

Mandatory Registration of Cosmetic Facilities

FDA requires businesses in most industries under its authority to register or report to the Agency prior to marketing their products in the United States.  Under current regulations, FDA does not require cosmetic establishments to register, but allows them to do so voluntarily.

The proposed bills would require facilities that manufacture, process, or (in some cases) distribute cosmetics for use in the United States to register with FDA.  Previously proposed bills have specified differing annual or biennial registration renewal requirements. The 2022 discussion draft included a provision for requiring cosmetics facilities to renew their registration annually..  Similar to past bills, the Act would require facilities located outside of the United States to designate an agent physically located in the United States to communicate with FDA on the facility’s behalf.

Mandatory registration of cosmetics facilities would provide FDA a paper trail of who is marketing cosmetics in the United States and would grant the Agency authority to detain or refuse products from unregistered establishments.  If this bill passes, FDA could suspend the registrations of facilities that violate regulations, effectively prohibiting them from marketing their products in the United States.

Cosmetic Ingredient Statements

This new bill would require cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States. The statement would contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings. FDA would require these statements be submitted within 60 days of marketing or reformulating the product and then annually (this is similar to a proposal under S.1113).

Cosmetic ingredient statements would notify FDA which products a particular facility processes and would allow the Agency to prohibit a cosmetic from being marketed without a valid statement.

Currently, cosmetics companies only need to report ingredients under certain circumstances. The California Safe Cosmetics Act of 2005 lists ingredients suspected to cause cancer or reproductive harm and requires companies that market products in California containing any of these ingredients to report the products to the state.

Another act that only applies to cosmetics marketed in California is the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA), which went into effect on January 1, 2022. CFFIRKA designates a subset of ingredients called “fragrance allergens” and specific ingredients that companies must report if being used as a fragrance ingredient (regardless of their function). The company named on the label must report these ingredients when present at a concentration of 0.01% (rinse-off cosmetics) or 0.001% (leave-on cosmetics).

Serious Adverse Event Reporting

The Personal Care Products Safety Act would require cosmetics businesses to submit serious adverse event reports to FDA. The bill’s definition for “serious adverse events” are generally health-related events associated with the use of a cosmetic that result in or require medical intervention. It also requires annual reporting of adverse health events such as rashes.

Like both S.1113 and S.2003, the Personal Care Products Safety Act would require the label of a cosmetic product to bear contact information for an entity located in the U.S. to receive notification of adverse events from consumers. A product not containing this information would be considered misbranded, subjecting it to detention or refusal at the U.S. border.

Good Manufacturing Practices

The Personal Care Products Safety Act would give FDA the authority to establish good manufacturing practices (GMPs) for cosmetics based on “current industry standards.” In other FDA-regulated industries, GMPs regulate production aspects such as sanitary conditions, hazard controls, and record-keeping. For cosmetics, GMPs would provide enforceable standards for FDA to reference during inspections. Violation of GMPs could result in regulatory actions such as Warning Letters, Import Alerts, and Import Refusals.

GMPs for cosmetics would be determined through FDA rulemaking. During rulemaking, FDA proposes a rule and allows industry and consumers to provide comment. Depending on the comments FDA receives, the Agency may issue an additional proposed rule for further comments, cease rulemaking, or issue a final rule.

A final rule contains compliance deadlines for industry, which are often determined by the size of businesses covered under the rule. It may take years for industry to see a rule’s full implementation as FDA prepares guidance and provides businesses time to process and comply with requirements.

Discover Cosmetri’s software solutions for cosmetics GMPs

Ingredient Review

The Personal Care Products Safety Act would also establish an annual review of cosmetic ingredients by FDA.  FDA would analyze safety data surrounding certain cosmetic ingredients to determine whether they are safe for use without restriction, safe under certain conditions or uses, or not safe for use at all.  FDA would then use these determinations to establish regulations that either permit or prohibit the use of certain ingredients in cosmetics.

The bill would even immediately prohibit products containing products that use harmful polyfluoroalkyl substances.

As more resources would be allocated to evaluating cosmetics’ safety, FDA may forbid or restrict the use of certain ingredients currently used in cosmetics. Businesses using these ingredients would need to reformulate their product to remain compliant.

In Conclusion

While the Personal Care Product Safety Act is not yet close to being passed, the push for the above requirements is supported by congressional Democrats and Republicans, and the proposed regulations bear significant resemblance to existing requirements in other FDA-regulated industries. Not only is reform supported by many elected representatives, but some cosmetic companies are also arguing for increased regulation of their own products. The Personal Care Product Safety Act has received support from several major cosmetic manufacturers, including Burt’s Bees Company, Johnson and Johnson, L’Oreal, and more.

Based on the consistency of proposed cosmetics safety bills, it is likely that one may be enacted within the next several years. If this change is realized, industry will need to adapt and adjust to continue business in the United States.

Get Assistance with Cosmetics Compliance

For assistance with FDA’s cosmetics regulations, contact leading FDA compliance consultant, Registrar Corp. Our Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more

Looking for a software solution? Try Cosmetri, software designed to simplify compliance for cosmetic companies.

Frequently Asked Friday: Does FDA consider my product a cosmetic or drug?

The U.S. Food and Drug Administration (FDA) regulates certain products that are commonly considered cosmetics as drugs. FDA regulations for drug products are strict and more comprehensive than regulations for traditional cosmetics, which can often cause confusion for manufacturers.

The distinction between a drug and cosmetic product is based upon the product’s ingredients as well as its intended use. Marketing a cosmetic product that may be subject to FDA drug regulations can result in the product being considered an unapproved drug.  Marketing unapproved drugs is violation of the Food, Drug, and Cosmetic (FD&C) Act and can result in criminal and civil penalties, warning letters, and other FDA enforcement action.

Drug vs Cosmetic Regulations

The difference in FDA regulations between cosmetics and drugs is significant. Cosmetic products may generally be marketed without FDA approval if they do not contain prohibited ingredients and appropriate claims are made. Cosmetic manufacturers are not required to register their facilities with FDA (although they may voluntarily), nor do they need to list their products.

On the other hand, drug facilities and products have stricter requirements. Drug facilities must register with FDA and list the drugs handled at the facility. It is important to note that registering with FDA does not mean you have obtained FDA approval.  Drug products must either conform to an over-the-counter (OTC) monograph or undergo the FDA approval process through a new drug application (NDA) to be marketed in the United States.

However, these differences may change in the near future. In September 2019, a bill called the Safe Cosmetics and Personal Care Products Act of 2019 was re-introduced to the U.S. House of Representatives. If passed, this bill would enact stricter regulation of cosmetics companies, including mandatory registration, standard good manufacturing practices, and ingredient statements.

Active Drug Ingredients in Cosmetics

FDA regulates cosmetic products as drugs when they contain active drug ingredients. For example, anti-perspirant deodorants contain Aluminum Zirconium Tetrachlorohydrex, an ingredient intended to prevent sweating (a function of the body). Other examples include anti-dandruff shampoos and acne-fighting cosmetics (Salicylic Acid), sunscreen and SPF face creams (octyl salicylate), and anti-cavity toothpastes (fluoride).

If an unapproved product containing active drug ingredients is marketed in the United States, the facility may face FDA enforcement action including detentions, import refusals, and Warning Letters. In the past year alone, FDA has refused nearly 3,000 drugs for lack of necessary approval, many of which are bath soaps, detergents, botox products, cleansers, deodorants and other “cosmetic” products.

Drug Product Claims on Cosmetics

Another common reason cosmetic products are regulated as drugs is because they make claims that they “diagnose, mitigate, treat, or prevent disease, or affect the structure or function of the body.” For example, some anti-aging creams claim to slow the process of aging by increasing the user’s production of collagen (a function of the body). Other examples include products that claim to repair skin or diminish irritation.

FDA has published a list of warning letters addressing products marketed as cosmetics that make drug claims.  In this warning letter issued to Health Habits, LLC, FDA states the following product description is evidence that the facility’s product is intended for use as a drug: “DermaTox® is an all-purpose skin wellness formula. Our customers tell us that they use DermaTox® daily to nourish their skin, speed healing, soothe the pain of a burn or bed sores, diminish irritation associated with eczema, psoriasis, rashes, cuts, bites, scrapes, spray on liver spots, moles, etc…”

Warning Letters are available to the public and thus can hurt your brand and reputation.  Typically, FDA gives facilities 15 working days to respond to a warning letter explaining how and when they will correct the noted issues.  Failure to respond to a Warning Letter within the allotted time can result in seizure of products.

Stay Compliant

Registrar Corp can help determine if your cosmetic products are regulated as drugs and help you to bring your products into compliance. Our Regulatory Specialists can assist you with FDA registration, labeling and ingredient reviews, and more.  For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

FDA Adds Hundreds of Products to Import Alert for Unapproved Drugs

On September 13, 2019, the U.S. Food and Drug Administration (FDA) added or updated hundreds of products and companies to its Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S. This is an abnormally high number of updates and additions for a single day.

An import alert informs FDA staff and the public that a product is eligible for Detention Without Physical Examination (DWPE) for violating FDA regulations. Many of the products in this case made claims on either their packaging or in their marketing that made them eligible to be considered drug products by FDA, thus requiring the products to be registered as drugs and in compliance with applicable drug regulations. FDA has strict rules for what claims a product can make; any deviation can be considered misbranding and result in regulatory action.

Claims for Non-Drug Products                                          

If you are marketing a food product and want to address its health benefits without it being regulated as a drug, there are claims you can make. Food products can make structure/function claims that relate an ingredient to affecting or maintaining the structure or function of the body. Claims about nutrient deficiency related health conditions (e.g. scurvy and Vitamin C) or promoting general well-being can also be used if they are applicable and are not misleading.

A product that claims to diagnose, cure, mitigate, treat, or prevent a disease will be regulated as a drug by FDA. Therefore, any food product making a disease claim about treating or all together preventing a disease would be viewed as a new drug by FDA and would thus require authorization and approval.

Many of the products placed on import alert were being marketed as a food product, a dietary supplement, or a cosmetic. However, these products made claims that qualified them as a drug. Some companies marketed dietary supplements with claims that they could “Help reduce excessive blood sugar” and could act as an “effective ayurvedic medicine.” Another product marketed as a food claims that it “makes stressed erythrocytes ‘Red Blood Cells’ (RBC’s) more flexible.” These claims are about curing and mitigating disease and are therefore considered drugs by FDA and regulated as such.

Products containing active pharmaceutical ingredients are also considered drugs by FDA. One product marketed as a dietary supplement contained the active ingredient Bufotenine, which is classified as a drug. One company marketed its nicotine patch as a cosmetic, but FDA regulates nicotine patches as OTC drugs. Ingredients must be considered before going to market in the U.S. to avoid a similar compliance issue. Registrar Corp’s infographic provides common examples of ingredients that would cause cosmetics to be regulated as drugs.

What does FDA Consider Labeling?

FDA defines labeling as any written, printed, or graphic matter upon any article or any of it containers, wrappers, or accompanying materials. FDA considers an article to be misbranded if either the physical label or any advertising is misleading to the form or function of the product. Advertising can include a wide range of materials from:

  • TV, print, or online advertisements
  • Content on a product’s website
  • Content on a product’s social media (Facebook, Twitter, etc.)
  • Published consumer or professional testimonials

Any claims or descriptions from a product’s advertising that are not consistent with the product information on the physical label could be considered misbranding. Some of the products placed on this import alert made claims that qualified their products as drugs on their websites or on social media platforms. FDA still considers these as part of the product’s labeling and reviews them when regulating products. When promoting your product, it is important to remain uniform in claims and descriptions made with what is directly on the label.

How Can Registrar Corp Help?

Registrar Corp is a private company that assists businesses in complying with FDA regulations. Our label review service can help determine if your labels are FDA compliant and evaluate claims made on your labeling. If your company is listed on the import alert, our specialists can help you petition for removal. For products that are appropriately marketed as drugs, we can assist in registering these facilities as drug establishments and create drug listings for these products.

Using our FDA Compliance Monitor, you can track your company and your supplier’s compliance status with FDA, allowing you to see if you or your suppliers are on an import alert, have a warning letter, or an expired registration. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.