Under the Federal Food, Drug and Cosmetic Act (“the Act”), products that are promoted for the prevention, treatment and/or cure of diseases are deemed drug products. 21 USC 321(g). This means that products that may otherwise be marketed as dietary supplements, including those that have “Supplement Facts” labeling and those containing only botanicals and vitamins, would be classified as drugs if they are marketed for disease treatment. Accordingly, it is important to ensure that dietary supplements are properly marketed in order to avoid classification as drug products and avoid FDA action.

When developing a product it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

FDA noted that there are no legally marketed over-the-counter (OTC) drugs that prevent nor cure the flu. However, there are legal OTC products that can reduce fever, relieve muscle aches, congestion, and other symptoms associated with the flu. FDA warns that dietary supplements labeled with flu treatments claims would be regulated as drugs by the Agency as products that are intended to treat, prevent, or cure diseases/conditions are deemed drugs under federal law. Accordingly, marketers of products with these claims should be very careful as they may be in violation of FDA laws and regulations.

In sum, when developing a product, it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

FDA Untitled Letters: Why It Matters?

Many businesses may be well versed when it comes to handling FDA Warning Letters, but when it comes to FDA Untitled Letters recipients of Untitled Letters may not fully understand how to respond. Accordingly, there are a few things to keep in mind once a FDA Untitled Letter is received. First, an Untitled Letter should not go unanswered, as the terms of the Letter require response, and a comprehensive response thereto could potentially save a business from being issued a Warning Letter or other enforcement action.

Differences between FDA Warning Letters and FDA Untitled Letters

1. Warning Letters describe alleged violations with both online marketing materials and print marketing materials, as well as product labels. Conversely, Untitled Letters appear to be focused solely on online marketing materials.

2. Untitled Letters are typically not published on the FDA’s website, unlike FDA Warning Letters, which are routinely published on the FDA website. However, it is important to note that although the Agency does not automatically post FDA Untitled Letters, non-response may trigger publication, reinforcing the importance of a response to FDA Untitled Letters adequately and promptly.

Assistance with FDA Untitled Letters

If you have received an Untitled Letter from the FDA it is vital that you do not disregard the letter. In particular, the receipt of a FDA Untitled Letter may signal an additional chance to resolve the issues cited by the FDA before risking receipt and publication of a FDA Warning Letter. If you are unsure what a FDA Untitled Letter means and what action must be taken, our Firm is available to help you with this process. Whether it be FDA Warning Letters or FDA Untitled Letter we can help you develop and implement necessary, corrective measures before your products or business face consequences. If you are in need of assistance please contact us at contact@sglawfl.com.

Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food & Drug Administration (“FDA”) works in conjunction with the U.S. Customs and Border Protection (CBP) to monitor cosmetic products at the time of entry. Noncompliance with FDA regulations can result in a shipment being refused entry into the United States or a product being recalled from the market after entry.

However, one may mistakenly assume that cosmetic products are subjected to the same FDA scrutiny as foods or medical device products. In fact, this is not the case; instead, the FDA’s focus on the cosmetics industry differs from the regulation of other FDA-regulated products. Unlike the FDA’s regulation of many other FDA-regulated, cosmetic products and their ingredients (with the exception of color additives) do not require FDA premarket approval and registration or approval requirements are largely inapplicable.

Cosmetic Products and Import Alerts

Due to the high volume of cosmetics imported into the domestic market, as a practical matter, not all cosmetics are inspected or sampled upon entry into the country. Rather than implement blanket inspections, the FDA focuses its inspection efforts on potentially risk-laden products in addition to conducting inspections of randomly-sampled products. As part of these targeted efforts, the FDA issues Import Alerts, which provide a risk monitoring system for the FDA and a signal to importers on the agencies regulatory focus. According to the FDA, Import Alerts for cosmetic products focus on cosmetic products marketed with therapeutic claims, those that are adulterated with microbial contamination, and products which fail to meet FDA requirements for color additives. As explained below, issues surrounding color additives present one of the more complex and important regulatory issues in the cosmetics industry.

Cosmetic Products and Color Additives

Under the authority of the Federal Food, Drug and Cosmetic Act (“FFDCA”), cosmetic products containing color additives are subject to a strict system of approval prior to entering the market. Certain color additives must be batch certified by FDA if they are to be used in cosmetics. Although some colors are exempt from batch certification, these colors are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations.

Further, all color additives must meet the requirements for identity and specifications. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product. With the exception of coal-tar hair dyes, failure to meet U.S. color additive requirements causes a cosmetic to be adulterated which may subject the product to removal from the market or detention. Accordingly, even when marketing cosmetics, there are important considerations from a FDA regulatory perspective, and compliance with these regulations will ensure smooth importation and marketing of cosmetics.

Navigating the web of regulations governing cosmetic products can be a daunting task. If you have any questions about FDA regulations or how these regulations relate to the marketing of a cosmetics products, please contact us at contact@sglawfl.com.

Based on evidence collected from its investigation, the DOJ’s motion alleged Bayer should be held in civil contempt for violating the 2007 consent decree concerning the requirement that Bayer substantiates its dietary supplement claims with scientific evidence. Specifically, the motion alleged that Bayer wrongfully made claims that PCH supports digestive health, and the product would help alleviate constipation, diarrhea, and gas and bloating without specific randomized, double-blind, placebo-controlled trials to prove that PCH offers these health benefits. In short, the Government’s position, like we have seen time and time again from the FTC, is that the Company must have conducted human studies in order to make the arguably dietary supplement-type claims.

In defense of the motion, Bayer produced as evidence a substantial amount of public domain and proprietary scientific evidence in support of its claims regarding PCH’s effectiveness in fostering digestive health. Further, Bayer argued the DOJ’s reliance on Bayer’s lack of substantiation of its product claims exceeded legislative intent for how dietary supplements should be regulated under the Dietary Supplement Health and Education Act (DSHEA). Thus, Bayer countnered the type of evidence required to substantiate claims under the DSHEA was not Laine-Level randomized clinical trials. In other words, Bayer argued that dietary supplements do not need the requisite level of substantiation that would be necessary for the approval of a drug under federal law. Accordingly, Bayer argued it only needed to conduct a periodic review of the literature since Bayer’s structure function claims were not implied disease claims and that the appropriate scientific substantiation standard for structure-function claims does not require Laine-Level randomized clinical trials.

The main takeaway from this is that for dietary supplement manufacturers making structure/function claims, courts may be willing to interpret this a less rigorous evidentiary burden when it comes to claims substantiation, as opposed to more highly regulated products. Additionally, and somewhat more controversially, this decision has been interpreted by some to signal that digestive health structure/function claims are more expansive than originally thought, potentially including constipation, diarrhea, gas and bloating.

Navigating the web of regulations governing claims regarding dietary supplements can be a daunting task. If you have any questions about FDA regulations or how they relate to the marketing of dietary supplements, please contact us at contact@sglawfl.com.

The FDA conducted an inspection in late 2014 that revealed that Stratus was marketing these topical products without first acquiring the required FDA-approved drug applications, which is typically required when marketing drug products under the Federal Food, Drug and Cosmetic Act (“FFDCA”). The FDA found these products to be drugs under the FFDCA, as opposed to cosmetics, like many other topically-applied products, as they were being marketed to treat various diseases and/or conditions, including:

• a solution used to treat excessive sweating;
• an antibiotic cleanser for treatment of skin conditions, such as acne, rosacea and seborrhea;
• a topical ointment used to treat wounds;
• a topical cream and gel to treat psoriasis, eczema and other skin conditions; and
• analgesic ear drops used to treat ear pain.

After the investigation concluded, the U.S. Attorney’s Office filed a complaint in federal court in the Southern District of Florida, alleging that the products sold by Stratus are unapproved new drugs and misbranded drugs under the FFDCA.

The FDA had the authority to seize Stratus’ products under the FFDCA, as explained in detail in the Marketed Unapproved Drugs Compliance Policy Guide. The compliance policy guide states that persons or companies that are marketing unapproved drugs are subject to FDA enforcement at any time. The FDA is not required to, and generally does not give special prior notice to a person or company that a drug product may be subject to enforcement action, including seizures.

The Policy guide also explains the priorities of the FDA for enforcement actions against violators. The enforcement priorities include drugs with potential safety risks, drugs that lack evidence of effectiveness, drugs that are reformulated to evade an FDA enforcement action, and unapproved new drugs that also violate the FFDCA in other ways (such as a new drug violating current good manufacturing practice).

Prior to marketing any product that may be deemed a drug or pharmaceutical product, it is very important that all steps be completed correctly to ensure compliance with, not only the Federal Food, Drug, and Cosmetic Act, but all other applicable laws. To ensure that your drug or cosmetic product is not in violation of federal law, it is important to consult with a seasoned professional.

We offer professional assistance to companies and individuals seeking to comply with all applicable rules and regulations. Our firm offers comprehensive review of structure function claims, label reviews, and health claims to help our clients ensure that their products are in full compliance with FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com.

The article focuses on cosmetics companies’ efforts to simultaneously promote their products effectively while abiding by all applicable laws and regulations. On this blog, we have previously discussed the challenges and pitfalls associated with marketing cosmetics with drug claims. In general, the FDA advises that, first, products intended to cleanse or beautify are generally regulated as cosmetics. Second, products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. Third, that some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. These products must meet the requirements for both cosmetics and drugs, as applicable.

Many small companies choose to invest in regulatory counsel before putting their products out on the marketplace. Giannamore described her role as a regulatory counsel as, “scal[ing] [the cosmetics companies] back, pointing out what things are definitely going to get you in trouble while keeping in mind that the product has to do something.” The marketing process is usually a risk aversion exercise, seeing how much risk the company wants to take on. She further described the role of regulatory counsel as, “finding creative ways” to convey the benefits of a product without violating the Federal Food, Drug, and Cosmetic Act.

Giannamore went on to tout the benefits of hiring regulatory counsel at an early stage of the product development process. “A lot of people come to me and they already have an FDA warning letter, or they’re importing and they’ve been stopped [due to excessive claims or other issues],” said Giannamore. Many times the companies do not hire regulatory counsel, “due to lack of resources in the beginning or it just not being something that’s high on the totem pole because they’re thinking ‘We’re a small company, [the FDA] is not going to target us.’”

Hiring regulatory counsel can prove to be a sound business decision, despite the cost, particularly because of the additional expense that would be incurred if the company receives a FDA warning letter. Recently, John Bailey, of the EAS Consulting Group and formerly a director of the FDA’s cosmetics program and the chief scientist at the Personal Care Products Council, addressed the substantial costs associated with an FDA warning letter or instituting corrective measures. The FDA may require companies to re-label their products and can have production and shipments shut down in the meantime.

The actual costs of an FDA warning letter may be even greater than just the cost to re-label products and lost sales. In addition, a FDA warning letter is a public relations nightmare, according to Giannamore. “If anybody’s ever Googling you, that’s now the first thing that comes up… They’re going to say ‘Oh my God, they have a warning letter; don’t buy their product.”

We offer assistance to companies with label reviews, reviews of their marketing content, and ensuring that products comply with FDA regulations. If you would like assistance with your cosmetics products, please contact us at contact@sglawfl.com.

FDA has recently noted that many cosmetic companies have crossed the line with claims on their advertising or packaging, causing products that would otherwise be regulated as cosmetics to be considered drugs by the Agency. Recently, the U.S. Food and Drug Administration (FDA) has been issuing warning letters to companies whose claims have gone beyond promoting the cosmetic benefits of their product and into the territory of promising outcomes typically associated with drugs, such as indicating that the product is intended to treat or prevent disease, or change the body’s structure or functions. If a company fails to comply with these rules, the FDA may take additional action beyond issuing a warning letter, which could include removal of a product from the market or other sanctions, which would likely prove costly.

Warning letters that have been issued to cosmetics manufacturers for marketing products with claims that indicate that the product is a drug can be found here. The products range from skin care creams and lotions, hair care products, and even eyelash and eyebrow treatments.

In general, the FDA advises that, first, products intended to cleanse or beautify are generally regulated as cosmetics. Second, products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. Third, that some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. These products must meet the requirements for both cosmetics and drugs, as applicable.

When promoting products in the cosmetics industry, it may be advantageous to sell the potential user on the benefits that they may experience. However, it is extremely difficult for any company to toe the line between cosmetic and drug claims. For this reason, it may be particularly helpful to have a trained professional examine the claims made regarding the product to ensure their compliance with all federal laws and FDA regulations.

We offer assistance to companies with label reviews and ensuring that products comply with FDA regulations. If you would like assistance with your cosmetics products, please contact us at contact@sglawfl.com.

According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs. As explained by FDA, the company undertook steps to correct the violations, but the Agency deemed the response ineffective. In February 2013, the FDA issued a warning letter to the company for violations of the CGMP and the Federal Food, Drug, and Cosmetic Act (FFDCA) by manufacturing and marketing both over-the-counter (OTC) and prescription drug products without an approved application (unapproved new drugs). According to the FDA Warning Letter, the Agency deemed the products to be drugs due to certain disease claims made in the Company’s marketing materials and since no approved applications were held by the Company, the products were deemed unapproved new drugs. For example, some of the claims at issue included: “Methods and composition for the treatment of vaginal diseases employing peroxide-producing enzymes and peroxidases,” “Helps Prevent The Causes Of Vaginosis, Yeast Infection and Bad Odor,” and “Probiotics: Potential to Prevent HIV and Sexually Transmitted Infections in Women.” Accordingly, the Company’s labeling was one of the major issues that led to FDA’s finding of unapproved new drugs, prompting FDA enforcement action.

On June 25, 2014, the FDA filed for a permanent injunction , as the Agency argued that the Company’s operations remained non-compliant with FDA regulations. That injunction was granted on January 30, 2015. One of the main issues here was Laclede’s failure to properly label their products. The consent decree for permanent injunction specifies that Laclede may not market any products with the words “prebiotic” or “actibiotic” on its labels or packages without first obtaining the FDA’s approval. In addition, Laclede may not market any products referencing “lubrication” without appropriate FDA approval.

In sum, properly labeling products is one of the most critical steps in the product development process. Compliance with the regulations is a must to ensure that your products stay on the shelf and that your company is not the subject of FDA enforcement action. Our firm offers comprehensive label reviews and packaging requirement assistance to help our clients ensure that their products are fully compliant with all applicable rules and regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com.

As we previously reported, on May 16, 2014, representatives from the U.S. Marshals Service had seized more than $11 million worth of unapproved drugs held by Masters Pharmaceuticals of Ohio and marketed by Ascend Laboratories of New Jersey. The U.S. Marshals seized urea cream 39%, hydrocortisone acetate suppositories 25 mg, urea cream 40%, pramoxine-HC otic drops, and urea lotion 40%. The FDA and U.S. Attorney for the Southern District of Ohio requested the seizure because the drugs were not marketed in accordance with FDA regulations, in that they were marketed for conditions that caused them to be deemed drugs but the Company had not secured the necessary FDA approval for the products.

The pramoxine-HC drops were intended to control itching and treat external ear infections caused by bacteria. Ascend Laboratories allegedly marketed the hydrocortisone acetate suppositories for the relief of symptoms caused by ulcerative colitis, inflamed hemorrhoids, and other inflammatory conditions. All three urea-containing products were intended to treat dermatitis, eczema, and other conditions that cause thickening of the skin.

Because none of these products have been proven safe or effective for their intended uses, i.e., obtained FDA approval for the treatment of these diseases and/or conditions, the FDA filed a Complaint alleging that the drugs were misbranded under the Federal Food, Drug, and Cosmetic Act. The complaint came approximately six months after an inspection revealed Ascend Laboratories was allegedly marketing certain products for the treatment of diseases and/or conditions without obtaining FDA approval.

The FDA’s announcement of this seizure explains that these drugs were seized under the Marketed Unapproved Drugs Compliance Policy Guide, which states that any unapproved new drug first marketed after September 19, 2011 is subject to immediate enforcement action even if the marketer never received a prior warning from the FDA. The FDA Compliance Policy Guide for unapproved marketed drugs lists several enforcement priorities. The first two priorities are drugs with potential safety risks and drugs that lack evidence of effectiveness. The FDA is also taking enforcement action against the marketers of so-called health fraud drugs. These products are represented as effective for diagnosing, preventing, curing, or treating diseases, but they have not been scientifically proven safe or effective for their intended purposes.

Drug manufacturers and marketers are subject to close scrutiny under the FDA’s guidelines. The agency has the right to seize drugs and other medical products without any prior warning, putting businesses in this industry at risk for serious losses. If you have any questions about FDA approval or you need help responding to a complaint filed by the FDA, contact us at contact@sglawfl.com.