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.

Getting a FDA Warning Letter for your tobacco business can be confusing. Responding to a FDA Tobacco Warning Letter can be even more confusing and time-consuming for a business. Although people often look to us for a sample response for their FDA Tobacco Warning Letter, unfortunately it is not that simple. While there are some common “Do’s” and “Don’ts”, there is no one-size-fits-all approach in responding to a FDA Tobacco Warning Letter. Accordingly, what we do is offer a tailored plan for responding to and resolving FDA Tobacco Warning Letters.

First, it is important to understand the underlying issues that prompted the Letter. Was it failure to check identification and underage sales or is the problem with labeling, etc.? Depending on the exact issues cited in the Tobacco Warning Letter, there are different measures that should be taken in order to adequately respond. For example, where there are labeling issues, label reviews and updates may be necessary in addition to submitting a response to the FDA to the Tobacco Warning Letter. If the issue is underage sales, there are other corrective measures that can help you bring your business into compliance with FDA requirements.

Once the issues that prompted the Tobacco Warning Letter are fully understood and corrective actions are completed, then a complete response detailing these measures must be addressed to the FDA. In Response to the FDA Tobacco Warning Letter, the Agency will want to see that all regulatory requirements are being addressed in a proactive way and that the business will be able to follow all regulations moving forward. Because these letters are often lengthy and technical in nature, we often provide these services to clients to help them ensure that they address any pending matters that may be of concern to FDA and allow them to get back to business.

For more information about responding to a Tobacco Warning Letter or how we may be able to help, you can contact us at (866)785-0873 or 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.

The FDA issued this warning to Young Living and its distributors for claiming numerous benefits on the labels of aromatherapy essential oil products with ingredients such as cinnamon, eucalyptus blue, ylang ylang and other essential oils. In addition to their labels, Young Living promoted these essential oils online, including the Company’s websites and social media platforms – with claims that the essential oils treat various conditions.

Here, Young Living was targeted by FDA because its aromatherapy and essential oils were incorrectly labeled and marketed. In particular, the Company failed to follow FDA guidance and regulations applicable to cosmetic products, and instead labeled their products for conditions that caused the products to be deemed drugs by the Agency. Thus, it is important for marketers and sellers of aromatherapy and essential oil products to understand and comply with FDA regulations.

As the aromatherapy and essential oil industry has recently seen a rapid increase in popularity, we expect to see more attention to and FDA enforcement in this area. Compliant labeling of products will help to ensure the successful marketing and sale of the aromatherapy and essential oil products. Our Firm offers the comprehensive label and marketing reviews to help our clients ensure that their products are fully compliant with all applicable FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com or (866)785-0873.

The FDA has been aggressively enforcing the Tobacco Control Act, largely against convenience stores and gas stations selling tobacco products in violation of the Tobacco Control Act by issuing tobacco warning letters quite frequently over the past several months. FDA regulations applicable to tobacco retailers prohibit the sale of cigarettes and smokeless tobacco to any person younger than 18 years of age, and impose other restrictions on labeling, marketing, and advertising of cigarettes and smokeless tobacco.

When a FDA compliance inspection reveals a violation, the tobacco retailer first receives a tobacco warning letter. A tobacco warning letter, like other FDA warning letters, contains a list of all of the violations observed during the inspection and directs the tobacco retailer to respond in writing with a plan to correct the observed violation. After receiving a tobacco warning letter, a business must respond to the FDA within 15 working days. The response to the FDA should include an explanation of the steps that the business will take to correct the violations and to prevent future violations, as well as the current contact information for the business.

After the receipt of a tobacco warning letter, if a tobacco retailer fails to correct the violation, it may result in the FDA taking regulatory action without any further notice to the tobacco retailer. Under the FD&C Act, as amended by the Tobacco Control Act, the FDA is authorized to issue a civil money penalty, no-tobacco-sale order, seizure, criminal penalties, and/or an injunction, which would prohibit the business from further tobacco sales.

Tobacco Control Act and Tobacco Retailers

The FDA can issue tobacco warning letters due to a number of different violations of the requirements set forth in the Tobacco Control Act. In particular, the regulations:

• Prohibit the sale or distribution of brand-identified promotional nontobacco items such as hats and tee shirts;
• Prohibit the sponsorship of sporting and other events, or teams;
• Prohibit free samples of cigarettes and restrict distribution of free samples of smokeless tobacco to “qualified adult-only facilities;”
• Require retailers to verify a purchaser’s age by photographic identification.

• Prohibit opening cigarette or smokeless tobacco packages to sell products in smaller amounts;
• Prohibit free samples of cigarettes.

Often, convenience stores and other establishments receive tobacco warning letters in connection with this final requirement – the failure to verify a purchaser’s age, which may also result in Warning letters issued by the FDA for violations of the Tobacco Control Act can be viewed here.

Tobacco Warning Letters: What’s Next?

If your business receives a tobacco warning letter or notice of a tobacco retailer inspection violations, it is extremely important that you take swift action to correct the violations. As stated in all tobacco retailer warning letters, a business only has 15 working days to respond to the FDA. Without a response, the FDA can pursue further legal action against your business with no further notice. 15 days is an extremely short period of time and once a warning letter is received, so swift action must be taken.

We can help you respond to tobacco warning letters and other FDA warning letters by reviewing the legal and regulatory basis for your warning letter, determining the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary, and drafting a response to your warning letter on your behalf. For more information about hiring a FDA regulatory lawyer to help you respond to FDA warning letters or how you can achieve FDA compliance, 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.

The consent decree and permanent injunction stemmed from a FDA warning letter issued to Health One in March of 2012, which laid out serious violations of FDA regulations rules. The FDA Warning Letter can be read in its entirety here. The FDA inspected Health One’s manufacturing facility in September 2011 and found serious violations of the FDA’s Current Good Manufacturing Practice (“CGMP”) for dietary supplements. Some of the violations that Health One received included failure to perform tests to verify the identity of dietary ingredients used to manufacture the supplements, failure to establish appropriate manufacturing controls, and failure to maintain, clean and sanitize equipment. Further follow-up inspections revealed that Health One failed to correct many of the manufacturing violations initially cited in the FDA warning letter. Since Health One was in violation of the CGMP, its products were considered “adulterated” by the FDA under the Federal Food, Drug, and Cosmetic Act.

There are CGMPs for various industries, including foods, dietary supplements, drugs and medical devices. To help businesses comply with FDA regulations and manufacturing requirements and explain the rules for industry, the FDA has issued guidance documents for many industries, which can be found here.

Compliance with the FDA regulations is an increasingly difficult task for businesses and failure to comply can spell disaster for companies. In order to avoid recalls and permanent injunctions, it is very important to comply with the CGMP’s and respond appropriately to FDA warning letters. If you have any questions regarding compliance with the various CGMP’s or the Federal Food, Drug, and Cosmetic Act, please do not hesitate to contact us at contact@sglawfl.com.