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 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.

BioAnue received a warning letter from the FDA on February 9, 2012, alerting the Company to what the FDA argued were numerous violations of FDA regulations. The Warning Letter can be found here. According to the FDA’s recent action, BioAnue not only failed to respond directly to the warning letter, the Company also failed to correct the violations highlighted in the Warning Letter. After having received the Warning Letter, the FDA conducted a follow-up inspection in August 2012, which, according to the FDA, revealed that BioAnue was still in violation of the FDA’s current good manufacturing practice requirements for dietary supplements and other regulatory requirements. More information about good manufacturing practices and the applicability of these practices to the dietary supplement industry can be accessed here.

In addition to FDA’s Good Manufacturing Practices, the FDA initially targeted BioAnue with a Warning Letter because they sold products that were marketed for use in the cure, mitigation, treatment, or prevention of disease. Marketing a dietary supplement for these uses causes dietary supplement products to be deem “drugs”, as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act found at 21 U.S.C. § 321(g)(1)(B). However, dietary supplements can be sold without being classified as “drugs” as long as they are not marketed with disease claims and instead are marketed with at most, structure-function claims or other permitted health claims. More information about structure-function claims may be accessed on the FDA’s website. However, it must be noted that sometimes the difference between a structure-function claim and a disease claim is not a bright line and even slight changes in wording can cause an otherwise permissible claim to be deemed a disease claim by the FDA.

We always stress the importance of responding to FDA warning letters with timely and adequate remedial measures, including resolving the issues cited in the letters, as well as promptly communicating with the FDA. You can read more about FDA warning letters and the importance of responding appropriately thereto here. FDA warning letters may be a serious threat to business, as seen in this case, where lack of response ultimately may be seen as prompting increased enforcement. Accordingly, it is possible that responding to a FDA warning letter can be the difference between maintaining business operations and being prevented from selling or marketing FDA-regulated products, as with the issuance of a permanent injunction. For more information about cases involving warning letters, please read some of our previous blog posts here.

If you have any questions about FDA labeling rules, warning letters, or compliance with FDA regulations pertaining to dietary supplements, please contact us at contact@sglawfl.com.

Beverages are considered a type of conventional food, which differ from dietary supplements in both labeling and the ingredients that are permitted. For example, beverages differ from dietary supplements in that the labels of these products bear nutrition facts panels, as opposed to supplement facts panels, and the products are also distinguished by claims made in labeling. For example, the Guidance document notes that beverages are intended primarily to “to quench thirst or otherwise provide a source of fluids (e.g., water, soda), provide nutritive value (e.g., milk, orange juice), or provide taste and aroma (e.g., hot cocoa).” Guidance at 6. By contrast, dietary supplements are products that are intended to supplement the diet and promote health in various ways. Accordingly, the claims that may be made in the labeling of beverage products are somewhat more limited than those made for dietary supplements.

In addition to differences in labeling, including claims, beverages differ from dietary supplements by the ingredients that are permitted. Under federal law, dietary supplements must contain one or more dietary ingredients, which include vitamins, minerals, herbs and amino acids. 21 USC § 321(ff)(1). As explained in the Guidance, “to be lawful for use in a conventional food, [an] ingredient must be used in conformity with a food or color additive regulation prescribing the conditions of its use in food, be GRAS for its intended use in food, or qualify for one of the other exceptions to the food additive definition.” Guidance at 7. Accordingly, the ingredients permitted in foods are more limited than those that may be used in dietary supplements.

In sum, whether a product is properly marketed as a beverage or a dietary supplement will depend on a number of factors, including labeling, intended use, and ingredients, among other things. Thus, when developing a product to bring to market or importing a product into the United States, it is important to ensure that these factors are considered to ensure that the product is properly regulated. If you have any questions about the differences between beverages and dietary supplements or how you can successfully market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

The FDA is targeting James G. Cole for unlawfully marketing its dietary supplements as unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). More specifically, the FDA is alleging that the company makes “drug claims” on its website and product labeling by promoting its dietary supplements as treatments for serious medical conditions such as cancer, heart disease, and arthritis. Under the FDCA, any product sold as a dietary supplement and promoted as a treatment, diagnosis, cure, or prevention of a disease or condition loses its status as a dietary supplement and is considered a new drug. Unlike drugs, the labeling of dietary supplements are only allowed to contain health claims, structure/function claims, and nutrient content claims, as permitted by FDA regulations.

Additionally, the FDA alleges that at the James G. Cole facility, the agency found serious violations of the cGMP requirements for dietary supplements, which are published in Title 21 of the Code of Federal Regulations, Part 111. These requirements mandate that any person who manufactures, packages, labels, or holds a dietary supplement establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled in compliance with the master manufacturing record. FDA argues that in violation of these regulations, James G. Cole did not establish an “identity specification” for each component in its dietary supplements and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.

In sum, failure to comply with the laws and regulations pertaining to dietary supplement labeling and manufacturing operations can have serious consequences, including the halting of distribution altogether. Accordingly, it is important to establish compliance with the laws and regulations enforced by the FDA in order to avoid costly delays and stoppages. If you have any questions about compliance with dietary supplement regulations or other laws enforced by the FDA, please contact us at: contact@sglawfl.com.

The FDA issued the warning letters as part of an initiative to remove illegal diabetes products from the market and thereby protect consumers from potential harm. Particularly, the targeted products make claims to cure, treat, mitigate, or prevent diabetes and related complications but have not been evaluated or approved by the FDA as safe and effective in treating diabetes, which causes them to be classified as unapproved new drugs as defined by Section 201(p) of the FDCA. Accordingly, many of these products have been targeted as unapproved new drugs simply for the claims made in product labeling, including product labels and other marketing materials.

In addition, as explained by the FDA, unapproved drugs may present safety risks such as possible contamination, harmful ingredients, and hidden active ingredients. For example, certain products that the FDA identified contained active pharmaceutical ingredients (APIs) that were not disclosed on the labeling. Products containing undisclosed APIs often make false claims as all-natural alternatives to FDA-approved drugs but may actually present a significant risk of harm. Additionally, many of the companies were illegally marketing and selling prescription drugs to consumers without a prescription, causing the drugs to be deemed misbranded under Section 503(b)(1) of the FDCA.

In sum, the companies have 15 business days from the date that they received the warning letters to submit written responses to the FDA. The responses to the warning letters must describe all the actions that have been or will be taken in a timely manner to correct the violations. Otherwise, the companies could be subject FDA enforcement actions such as injunction, criminal prosecution, and/or product seizure. More information about warning letters and ensuring adequate responses thereto may be found here.

If you have any questions about compliance with FDA requirements concerning the marketing of FDA-regulated products, please contact us at: contact@sglawfl.com.

Under the FFDCA and FDA regulations, dietary supplements are categorized as a type of food product. While federal law and regulations allow certain types of claims to be made about dietary supplements, i.e., structure-function claims and/or health claims, these products may not be represented as being effective in the treatment of any disease or condition in man. Thus, claiming that a product is beneficial in the treatment of a disease, known as a “disease claim,” is sufficient to cause a product to be deemed a drug by the FDA. Further, because new drugs require pre-approval by the FDA prior to marketing, allegedly improper claims may not only render a supplement to be deemed a drug – but an unapproved new drug at that. Thus, it is critical to ensure that only permissible claims appear on product labeling, including product labels and other marketing materials.

Warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Under the terms of a warning letter, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. Firms must respond to all violations, including those not explicitly cited by the Agency. Because appropriate corrective measures often preclude further enforcement, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance. For more information about establishing or maintaining compliance with the regulations or laws FDA enforces, please contact us at contact@sglawfl.com.