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 Standards of Identity and Dairy Labeling

The term “milk” is defined by the FDA under 21 CFR 131.110 as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cow.” Thus, in order to meet standard of identity requirements, a product labeled as “milk” must have animal origin. According to industry groups backing enforcement of this distinction, labeling almond milk as milk is misleading because almond milk is plant-based and was not derived from a dairy animal. Accordingly, the Bill aims to restrict the ability of beverages made from plant foods from using the term “milk” on their labels. Additionally, enforcement of these regulations pertaining to naming of dairy affects other dairy-based products, like those labeled as cheese and yogurt.

In sum, the Spending Bill directs the FDA to strictly enforce labeling standards of what can be labeled as “milk”. Per the terms of the Bill, FDA has 180 days to release a guidance document detailing how the dairy labeling standards will be implemented and enforced. If you have any questions about FDA regulations or how you can bring your labels into compliance with FDA regulations, please contact us at contact@sglawfl.com. 

Honey is defined as a “thick, sweet, syrupy substance that bees make as food from the nectar of plants or secretions of living parts of plants and store in honeycombs.” If a food contains only honey, then it must be named “honey” and may also include the source of the honey.  Since a honey is a single-ingredient food, it is generally not necessary to include an ingredient statement on the label. If a food contains honey and a sweetener or honey and a flavor ingredient, then it cannot be called “honey”. Rather, the food product would need to bear a standard of identity (again, not “honey”) and bear an ingredient list on the information panel of the label.

FDA Labeling and Regulations for Honey Products

Under federal law, if a food product is labeled “honey” but contains flavor or other ingredients, the FDA would consider this product to be misbranded and/or adulterated. 21 CFR 101.4(a)(1) and 403(i)(2). Additionally, the FDA has an import alert for violative honey products and affected products would be detained until the product is deemed not adulterated or misbranded. Import Alert 36-01.

In sum, whether a product has compliant FDA labeling and is properly marketed as “honey” or a honey-related product with additional ingredients will depend on what ingredients, if any, are added to the honey. Thus, when developing a product to bring to market or importing a product into the United States, it is important to be sure that FDA labeling requirements are considered to ensure that the product is properly regulated.

If you have any questions about the proper FDA labeling of “honey” and honey products or how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com

Multi-Level marketing is often used in the dietary supplement and cosmetics industry. Sellers become a Multi “level” marketer because they market and distribute a certain product through a chain of individuals, such as with HerbaLife and Young Living. While the MLM model may be a useful tool for companies to market products quickly and efficiently, regulations pertaining to advertising and marketing, such as those enforced by the FDA and FTC still apply.

Prompted by recent events, like the actions taken against HerbaLife International, the FTC Guidance aims to provide a better understanding of the FTC’s expectation for the MLM businesses and the responsibilities that these companies have when it comes to marketing their products. In particular, one of the main components the Guidance addresses is how MLMs should establish compliance programs aimed at ensuring the companies maintain oversight into the sales activities of their teams. These compliance programs should include constant supervision of the distributors of the product, to confirm that they are abiding by the applicable policies and procedures, specifically those associated with claims, sales validation, and other consumer protection-oriented policies.

This new Guidance equips businesses with FTC’s current thinking on what is in conformity with the FTC Act. To ensure businesses are complying with the rules and regulation put forth by the FTC, it is important for businesses to reexamine their practices and to create compliance programs or revise existing programs for compliance with the FTC Act and FTC MLM Guidance.

Should you need assistance with developing a plan for compliance with FTC’s MLM policies or have questions about marketing laws and regulations, please contact us at contact@sglawfl.com.

In the recently published FDA guidance, the FDA is instructing its staff not to consider “general wellness products” as “devices” for purposes of the FDCA, meaning that these low risk devices will not have the considerable oversight that other “devices” receive from the FDA. The proposed guidance document defines a “general wellness product” as meeting a two-factor test. First, that the products are intended for only general wellness use, as defined in this guidance. Second, that the products present a very low risk to users’ safety. However, the decision by the FDA not to regulate these products does not mean that those classes of products are safe, effective, and not misbranded for its intended use.

General Wellness Products

For a product to be classified as a general wellness product, it must meet one of two criteria:

1. It must have, “an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity;” or

2. It must have an, “intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of                  certain chronic diseases or conditions…”

General wellness products are allowed to make claims about improving a general state of health, but they must not make any references to diseases or conditions. General wellness products are only allowed to make references to diseases or conditions when it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. This means that generally accepted science has proven that healthy lifestyle choices may play an important role in health outcomes.

Low Risk Devices

If a product presents an inherent risk to the safety of the user, then it is not exempted by this guidance document. If a product does any of the following four things, then it is not a low risk product for purposes of this guidance document and is not considered a general wellness product if:

1. the product is invasive;

2. the low risk device involves an intervention or technology that may pose a risk to a user’s safety if device controls are not                    applied, such as risks from lasers, radiation exposure, or implants;

3. it raises novel questions of usability, or

4. if the low risk device raises questions of biocompatibility.

This guidance document is an interesting stance from the FDA insomuch as the FDA is taking a self-limiting position by essentially saying that the Agency should not be regulating these devices. Rarely does the FDA take such a self-limiting stance on issues of product regulation. However, just because the FDA is not regulating these General Wellness products, it does not mean that they are completely unregulated. The Consumer Product Safety Commission (CPSC) may also have the authority to decide whether a general wellness product is a consumer product under CPSC’s authority vested in it by the Consumer Product Safety Act. Accordingly, how this guidance document and federal law will be applied in practice remains to be seen.

A guidance document serves as the Agency’s official stance on a subject. Further, it does not create any legally enforceable duties upon the Agency. It solely guides the decision makers within an agency to uniformly apply the specified laws and regulations. This proposed guidance document is open to public comment before it becomes final. Currently, electronic comments can be sent to the FDA at this website. The public comment period is open for 90 days, and then the Agency will review all of the comments that are received and will finalize the guidance document.

Navigating the web of regulations and regulatory bodies can be a daunting task. When selling or distributing a product, a company must be absolutely certain that they are meeting all regulatory requirements or risk enforcement action. If you think your product may be affected by the new guidance document and want to be sure your claims and labeling are in compliance or see how you may be regulated by FDA, our office offers reviews of product labels and health claims. If you have any questions about the new guidance document or whether your product is considered a “device” please contact us at contact@sglawfl.com.

Major food allergens are defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as “[m]ilk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans” and also as any food ingredients that contain protein derived from these foods. This definition currently excludes highly refined oil that has been derived from a major food allergen and any ingredient derived from such highly refined oil. The term “major food allergen” was first defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II of Public Law 108-282), which was incorporated into and amended the FFDCA.

Exemptions from the food allergen labeling requirements as found in section 403(w)(1) of the FFDCA, as amended by FALCPA, must be done through a petition and notification process. Such process includes a declaration by the petitioner that the ingredient for which exempted relief is being sought does not cause an allergic reaction, pose a significant risk to human health, or contain an allergenic protein. However, as explained in the guidance document, manufacturers of such products that wish to claim the exemptions must submit detailed petitions to the FDA before omitting major allergen labeling.

Understanding how to properly label foods with the necessary food allergen labeling information is important. Products that are improperly labeled (i.e. contains an undeclared allergen) often result in recalls and enforcement actions by the FDA. More information the consequences of failure to declare allergens in labeling may be accessed here.

If you have any questions about food labeling, including compliance with FDA requirements pertaining to major food allergen labeling, please contact us at: contact@sglawfl.com.

The Guidance sets forth the Agency’s current thinking pertaining to honey labeling. In particular, the FDA notes the proper uses of the term “honey” in labeling and notes that labelers may state the name of the source of honey, such as plant or blossom, depending on whether this source is the chief floral source of the honey. More information about the labeling of honey can be found here.

In addition to honey labeling issues, the FDA monitors the importation of honey and honey products to check for adulteration caused by the addition of corn sugars and sugar cane. Under sections 402(b)(1) through 402(b)(4) of the FFDCA, a food is considered to be adulterated if an important component has been withheld from a food, any element has been fully or partially replaced or a component has been added to the food in order to inflate the weight or size, decrease quality or to make it seem superior in quality. Accordingly, products labeled as honey that contain added corn sugars, sugar cane or other substances would not be released into American distribution until the FDA finds that the honey has not been adulterated.

In sum, in order to import honey products without issue, industry is responsible for ensuring honey labeling is compliant with regulations and that honey products, as formulated, are not otherwise found to be adulterated under federal law. If you need assistance with honey labeling, importing or maintaining compliance with the laws and regulations enforced by the FDA, contact us at contact@sglawfl.com.

More specifically, the plan lists six goals: (1) reduce foodborne illness rates and cosmetic injury rates each year; (2) establish regulations, policies, guidance, and inspection and compliance strategies based on best science, prevention, and public health risk; (3) increase compliance with newly created preventive control standards across the farm-to-table continuum; (4) improve public health indicators through better nutrition and dietary choices; (5) develop and swiftly deploy the fastest and most effective methods for identifying, containing, and eliminating food and cosmetic hazards.

Each of the six goals corresponds to specific objectives. For example, the Center intends to continue to implement the provisions of the Food Safety and Modernization Act (FSMA). Particularly, in 2014 and 2015, it plans to publish preventive controls—as required by FSMA—for produce, food processing facilities, and food transportation. CFSAN will also publish a final rule for intentional contamination, address an approach to determine high-risk foods and the most significant foodborne contaminants, and draft recordkeeping requirements for high-risk foods.

Additionally, the Center plans to improve the safety and labeling of dietary supplements. This includes developing regulations for “energy drinks” and publishing final guidance to help dietary supplement and beverage manufacturers determine whether a liquid food product, such as an energy drink, may be labeled and marketed as a dietary supplement. By the end of 2013, it will publish draft guidance for new dietary ingredients.

Next, CFSAN has been working to develop new food labeling regulations. Specifically, CFSAN will update the nutrition facts labeling and serving size information on food labels. The Center had also planned to publish a final rule defining gluten-free and on using the term on food labels in 2013, which the Center accomplished on August 5, 2013. In 2014, the Center plans to finalize rules required by the Affordable Care Act of 2010, specifically to require nutrition information on menus and vending machines.

Finally, CFSAN plans to reduce risks related to cosmetics. For example, it will publish guidance on current good manufacturing requirements for cosmetics and finalize guidance regarding the effects of manufacturing process changes, such as nanotechnology, on the safety of cosmetics. In 2014, it intends to develop draft guidance on the use of lead in lipstick.

If you have any questions about this new plan or compliance with FDA regulations, please contact us at: contact@sglawfl.com.

More specifically, a medical food—defined in section 5(b)(3) of the Orphan Drug Act (ODA)—is a food “which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Pursuant to 21 CFR 101.9(j)(8), which clarifies the definition of a medical food under the ODA, a food is a medical food only if it meets certain criteria, particularly if it is: (1) specifically formulated and processed for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube; (2) intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone; (3) intended to be used under medical supervision and (4) intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

As explained in the draft, medical foods are generally regulated as conventional foods but are exempt from the labeling requirements for health claims and nutrient content claims under the Nutrition Labeling and Education Act (NLEA) of 1990. Aside from applicable exemptions, however, medical foods must comply with all FDA requirements pertaining to conventional foods. This includes the Current Good Manufacturing Practices (cGMPs) published in 21 CFR part 110, the food facility registration requirements in 21 CFR part 1, subpart H, and all food allergen labeling regulations. Industry compliance with these regulations is explained by the FDA’s Compliance Program Guidance Manual.

Significantly, medical foods are not considered to be drugs and are not required to comply with regulations applicable to drugs specifically. For example, the FDA does not require medical foods be made available by written or oral prescription, as this only applies to the dispensing of prescription drug products. Additionally, the agency notes that certain labeling statements intended for drugs can cause a medical food to be misbranded. The labeling on medical foods, for example, must not include National Drug Code (NDC) numbers because NDC numbers are intended to unique identify drugs only. Including an NDC number on the labeling of a medical food will cause the product to be misbranded under 403 (a)(1) the Food, Drug, and Cosmetic Act (FDCA).

In all, the FDA distinguishes between the types of conditions for which medical foods can be labeled and marketed and those for which they cannot. Inborn errors of metabolism (IEMs) are typically considered appropriate for the use of medical foods. Classical nutrient deficiencies, pregnancy, and diabetes are not considered by the FDA to be appropriate; foods intended to address these conditions should not be labeled as medical foods.

When finalized, the draft guidance will represent the agency’s current interpretation of the requirements for medical foods. Comments must be submitted within 60 days of its publication (October 11, 2013). If you have any questions about medical foods, including compliance with FDA requirements, please contact us at: contact@sglawfl.com.

In the warning letters, these firms were strongly advised to correct marketing practices on specific products immediately and to submit a response to the warning letters with a specific plan to get their marketing practices in line with the requirements of the Federal Food, Drug and Cosmetic Act (“FDCA”). These warning letters can be read in their entirety by clicking here and here. Under the terms of the warning letters, the companies were also directed to submit a written response within 15 business days from the receipt of the warning that details the corrective actions they have taken to become compliant with the FDCA and FDA regulations.

The violations these companies have been targeted for fall into two general categories. Marketing cigarettes as “light”, or “ultra-light”, and marketing flavored cigarettes. The FDA does regular compliance checks to make sure tobacco retailers are in compliance with FDA regulations, the FDCA and its various amendments, including the Family Smoking Prevention and Tobacco Control Act. This Act, which was signed into law by President Barack Obama in 2009, gives the FDA the power to regulate the manufacture, distribution, and marketing of the tobacco industry.

Provisions of the Family Smoking Prevention and Tobacco Control Act require placement of new warnings and labeling statements on tobacco products and specifically ban flavored cigarettes. The Act also requires FDA approval to use marketing terms such as “mild”, “light”, or “low” that can give a false impression that the product poses less of a health risk than a conventional tobacco product. The ban on flavored cigarettes is an attempt by the federal government to discourage young people from taking up the habit, as it is the government’s stance that these flavors particularly appeal to younger consumers. More information about FDA guidelines for marketing tobacco products can be accessed here.

Failure to comply with federal law and accompanying FDA regulations can result in serious consequences. While warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FDCA and/or FDA regulations, failure to resolve the issues cited therein may result in more stringent action. Because appropriate corrective measures may often preclude further enforcement measures, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance and doing so may help a company remain in business without further problem.

For questions about FDA regulations regarding the manufacturing, distribution, and marketing of tobacco products or how you can effectively respond to an FDA warning letter, please contact us at contact@sglawfl.com.