• 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.

FDA Standard of Identity and Dairy Labeling

Under 21 CFR 131.110, the FDA defines “milk” 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 for product labeling, a product labeled as “milk” must have animal origin, i.e., be actual dairy. According to dairy industry groups, who support the current standards of identity, labeling almond milk or soy milk as milk is misleading because the product is plant-based and was not derived from a dairy animal. In addition to milk, the regulations pertaining to naming of dairy affects other dairy-based products, like those labeled as cheese and yogurt.

Only time will tell whether the standards of identity for dairy products will be modernized by FDA. 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. 

Although the Food Safety Modernization Act (FSMA provides the U.S. Food & Drug Administration (FDA) with the authority to issue mandatory recalls for unsafe food products, most companies issue voluntarily recalls when a mislabeling or adulteration issue arises. One reason that we continue to see voluntary recalls is that the FDA must undertake certain procedures before ordering a mandatory recall.

In order to issue a mandatory recall, the FDA must first determine that the criteria for mandatory recall has been met. Criteria for a mandatory recall may be that the food is adulterated under Section 402 of the Federal Food Drug & Cosmetic Act (FDCA). Adulteration occurs when the food (including dietary supplements) contains poisonous or deleterious substances or a substance that is otherwise unfit for food.  A food may be misbranded under the FDCA when the product labeling does not meet federally mandated requirements. For mandatory recall authority, misbranding under Section 403(w) of the FDCA would be where required major allergens are not displayed in product labeling, thus creating risk to consumers who rely on allergen warnings when making food choices.

Once mandatory recall authority has been established, the FDA must then give the company an opportunity to issue a voluntary recall. If the company still does not undertake a voluntary recall, despite FDA correspondence indicating that the criteria for recall has been met, then FDA can issue a mandatory recall. Because FDA must follow this protocol, it is unlikely that FDA’s exercise of mandatory recall authority will ever become the rule rather than the exception.

If you have any questions about FDA regulation or how you can establish and maintain 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.

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.

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.

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 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.