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.

• Milk;
• eggs;
• fish;
• crustacean shellfish;
• tree nuts;
• peanuts;
• wheat, and
• soy.

Food Allergen Labeling

Under FALCPA and accompanying FDA regulations, major allergens must be declared in the labeling of all food products (including dietary supplements) sold in the United States. If the major allergens are not appropriately declared, companies face the possibility of detention/refusal, warning letters, and (because allergens invoke serious health risks to consumers) even recalls. Accordingly, it is important for marketers to stay up-to-date with current labeling regulations to avoid costly mistakes.

Interestingly, although the major food allergen list in the United States has some overlap with those food ingredients considered major allergens abroad, there are some distinctions. For example, in the European Union, sesame seeds are already deemed a common allergen, as are celery, mustard and other items not named on the major allergen list in the United States. Thus, as with other labeling components, it is important that importers and marketers of FDA-regulated food products are knowledgeable of FDA food labeling requirements since there are key differences for products sold in the U.S. market.

For more information about food regulations or our services, please visit us at Giannamore-law.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.

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 also notes that this recent move is driven by recent private litigation surrounding the term “natural” in which some federal courts requested administrative determinations from the FDA as to the propriety of labeling of food products containing genetically engineered ingredients or high fructose corn syrup as “natural.”

While FDA regulations presently do not offer a formal definition of the term “natural,” the Agency has maintained a longstanding policy concerning the use of “natural” in human food labeling. FDA’s nonbinding guidance on this subject defines “natural” as “nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, food that would not normally be expected to be in the food.”  Although this policy touches on the qualitative aspects of food, this policy does not address production methods and food processing or manufacturing methods. Further, the FDA also does not presently consider in its non-binding guidance whether the term “natural” should describe any nutritional or another health benefit derived from such foods.

As part of the public comment process the FDA requests information on whether it is appropriate to define the term “natural;” suggestions as to how the agency should define “natural,” and the term’s appropriate use of the term on food labels. The FDA is accepting public comments through February 10, 2016.

For more information about hiring a FDA regulatory lawyer to help you develop FDA-compliant labeling or how you can achieve FDA compliance, 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.

Because several products promoted on the website are not generally recognized as safe and effective for eradicating the Ebola virus, the FDA considers them new drugs under §505(a) of the Federal Food, Drug, and Cosmetic Act. Under this act, a drug may not be introduced or delivered for introduction into interstate commerce unless the FDA has determined it is safe for consumers.

The FDA also alleges the products promoted by Dr. Laibow are misbranded under §502(f)(1) of the Federal Food, Drug, and Cosmetic Act. These products are considered misbranded because they are offered for conditions that cannot be self-diagnosed or treated by someone who is not a medical professional. As a result, there is no way to provide adequate instructions for using the products safely and for their intended use.  The Warning Letter gives Dr. Laibow 15 working days to submit a list of steps taken to correct these violations.

The FTC alleges Dr. Laibow violated the FTC Act by making product claims without reliable scientific evidence. Under the FTC Act, it is unlawful to claim that a product can treat, prevent, or cure disease in humans unless there is competent and reliable scientific evidence to support those claims. The FTC advised Dr. Laibow to carefully review all claims and ensure there is scientific evidence to support them. Dr. Laibow has 15 working days to respond to the FTC’s concerns.

Although a FDA Warning Letter constitutes an informal action on the part of the FDA, it is a sign that a formal enforcement action may happen if a company does not address the alleged deficiencies. This is why it is so important to take these warnings seriously. The FDA often targets companies making claims related to highly publicized outbreaks. Since the Ebola outbreak made the news, the Agency has also sent FDA warning letters to Young Living Essential Oils and doTERRA Essential Oil because their independent consultants allegedly promoted essential oils as an effective treatment for the Ebola virus.

If you have any questions about complying with the Federal Food, Drug, and Cosmetic Act, or you have received a FDA warning letter, contact us at contact@sglawfl.com to discuss your concerns with counsel.

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.

The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk for stroke and heart attack in users), and Phenolphthalein, an inactive ingredient linked to cancer risk, were found in multiple test samples from various distributors. The FDA warning letter was issued to manufacturers of Zi Xiu Tang Bee Pollen, threatening that seizure of product and criminal prosecution measures would be taken should they refuse to comply with proper labeling under FDA guidelines. Despite this warning, manufacturers and distributors of Zi Xiu Tang Bee Pollen continued its marketing and labeling practices, resulting in the FDA issuing an Import Alert to ban the product’s entry into the US market. Further action, if warranted by the FDA, may include the issuance of additional warning letters to the company and heightened enforcement action, including product seizures, injunctions and possible criminal charges.

The problem of undeclared ingredients in weight loss supplements and other products, drug ingredients or otherwise, is taken very seriously by the FDA. As evidenced by the February 14, 2013 raid of Globe All Wellness, LLC by U.S. Marshals acting on behalf of the FDA, the measures taken to uphold the requirements of the Federal Food, Drug and Cosmetic Act (FFDCA) can be severe. FDA warning letters, product recalls and seizures, and ultimately criminal prosecution can occur where noncompliance with these requirements is found. Companies, including manufacturers, or distributors of products that have received a warning letters from the FDA should take these issues seriously and take steps towards achieving compliance in order to avoid heightened scrutiny and enforcement by the FDA.

If you have any questions about the FDA warning letters and how you can maintain compliance with regulations pertaining to the labeling and marketing of these products, 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.