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 U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of Partially Hydrogenated Oils (PHOs).  FDA recently issued its final decision on how it would categorize PHOs.  Following through on an effort the FDA began in 2013, the categorization of PHOs officially changed to not generally recognized as safe (GRAS) for use in food, effectively banning trans fats.  This change in categorization now puts PHOs under the regulations that govern food additives.  Current registrations of foods containing PHOs and their labeling must eliminate PHOs by June 2018.  The FDA will allow registrants to obtain new registration of use of PHOs in foods under much stricter guidelines.

FDA’s Long Pursuit of Trans Fats – A Troubled Relationship

The FDA began its relationship with trans fats and PHOs in 2006 when the FDA required that the amount of trans fats in a food be put onto the ingredients listing of the FDA-required Nutrition Facts label.  Trans fat is listed as a part of the Saturated Fat listing.  Since trans fat is typically a percentage of Saturated Fat, trans fat could list at zero grams but still be present in the food, up to 0.5 grams of trans fat, and allow the continued use of PHOs.  This is no longer the case.

The reason PHOs became important in the food industry is that PHOs have a longer shelf life and are cheaper than other fats and oils to use in recipes.  Removal of PHOs from a food means potential changes to the Nutrition Facts label for that food.  Additionally, for an imported food currently containing PHOs, the importer will be responsible for getting its food source manufacturer to reformulate and eliminate the PHOs.

FDA’s Scope on PHOs and Trans Fat is Black and White

Using the Federal Register to issue a Declaratory Order, rather than proceeding through formal rulemaking (with the necessary notice and comment periods) the FDA has set its boundaries on what is non GRAS, on what must be eliminated, and what occurs outside these boundaries.  One boundary is that this order is for PHOs only and excludes FHOs, fully hydrogenated oils.  The Order also excludes naturally occurring trans fats, those that are not a part of PHO manufacture.  The Order clearly defines PHOs as “as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.”    The Order also provides that “Any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s).”

FDA’s follow-up … What’s Next?

The FDA will be busy from now through June 2018 with updates to a multitude of Nutrition Fact labels, as well as new and revised food additive submissions seeking FDA’s approval to use PHOs in some “safe” manner.  For food imports containing PHOs, this means an updated recipe with an updated Nutrition Fact label, otherwise the importer may lose the ability to import.  FDA will then be able to seize imported foods and additives containing unapproved PHOS, categorizing them as adulterated, illegal imports.  With three years available to make necessary changes, violators will get little sympathy from the FDA, and may be subject to warning letters and seizure for continued non-compliance.

We can help you comply this order and other FDA regulations by reviewing the legal and regulatory basis for your updated Nutrition Facts label and determine the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary. For more information about hiring a FDA regulatory lawyer to help you respond to this FDA Declaratory Order or how you can achieve FDA compliance, please contact us at contact@sglawfl.com.

FDA

On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring that calorie counts be listed on menus and menu boards in certain restaurants and vending machines (menu and vending labeling rules). The full text of the menu and vending labeling rules can be found here. The menu labeling rule applies to restaurants if they are part of a chain of 20 or more locations, doing business under the same name, and offering more or less the same menu items. The 1990 Nutrition Labeling and Education Act established nutrition labeling on most foods, but food from restaurants was not covered under this Act. Rather, the menu and vending labeling rules were mandated by the 2010 Patient Protection and Affordable Care Act.

Menu Labeling Rules

Under the new menu labeling rules, calorie counts must be displayed clearly and conspicuously, either next to the name or price of the item. In addition, the calorie count must be labeled in the same size and colored font as the associated food item. However, it must be noted that there are certain foods that are exempt from the calorie count requirements under the menu labeling rules. Condiments for general use, seasonal menu items, and daily specials are all exempt from having their calorie counts displayed. Establishments also must publish the following statement on their menus and menu boards, “2,000 calories a day is used for general nutrition advice, but calorie needs vary.” In addition to calorie counts, and upon consumer request, restaurants are required to provide written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars, and protein.

Even though many state and local governments have passed their own rules and regulations regarding calorie counts, FDA suggests that these federal rules preempt any local rules on the topic, unless the local rules are identical to the federal rules. However, restaurants and other establishments not covered by the federal rules may still be subject to state and local regulations regarding calorie counts. All menu and labeling rules must be met within one year by all covered restaurant entities. For additional information, the FDA has answered many of the frequently asked questions about the new requirements, accessible here.

Vending Labeling Rules

The new rule mandating calorie counts for vending machines (“vending labeling rule”) can be found here. This rule requires vending machine operators with 20 or more vending machines must disclose calorie information for foods sold from the vending machines. Vending machine operators have two years to comply with this rule. Failure to comply with the vending labeling rules will render covered vending machine food misbranded under the Federal Food, Drug, and Cosmetic Act.

Navigating the menu and vending labeling rules can be a difficult task for any restaurant or vending machine operator.  If you would like to have your menu or website reviewed for compliance or if you think your restaurant or vending machine company is subject to these new menu and vending labeling rules and have questions about how to comply with FDA requirements, please contact us at contact@sglawfl.com.

The Court found that the FDA would have to utilize formal device reclassification procedures if the Agency wanted to make changes to the device’s status. Device reclassification, which is accomplished through the formal rulemaking process, removes a device from the market, requiring the device to go through the approval process before it can be marketed again. This process includes a notice and public comment period before the device reclassification is finalized and the device may be removed from the market. Accordingly, by finding that the FDA must actually reclassify a cleared device in order to have the authority to effectively change its previous determination, the Court found that the FDA had exceeded its authority in the present case. In addition, the Court struck down the FDA’s assertion that it had “inherent reconsideration authority” when reclassifying a device. The court’s holding reinforces the importance of the device reclassification procedures outlined in the Federal Food, Drug, and Cosmetic Act (“FFDCA”), which include notice and public comment through formal rulemaking.

The Federal Food, Drug, and Cosmetic Act mandates that the FDA classify medical devices into one (1) of three (3) categories, Class I, Class II, and Class III. Class I devices generally pose little to no risk and are subject to the least amount of regulatory controls. Class II devices are higher risk devices that require increased regulatory controls and typically must receive clearance prior to marketing. Class III devices are the highest risk devices and are subject to the strictest regulatory control; Class III devices must be approved by the FDA prior to being released to the market.

Generally, prior to marketing a Class II device, the device sponsor must utilize the Premarket Notification process, as prescribed in Section 510(k) of the FFDCA. For more information on Section 510(k) please visit our website. Failure to comply with Section 510(k) can result in serious consequences. For Class III devices, Premarket Approval, as distinguished from clearance, is required, unless it falls under the exemptions found in applicable FDA regulations.

With respect to device reclassification, the FDA must take very specific steps, as outlined in section 515 of the FFDCA, in order to properly reclassify a device. In particular, the FDA must do five (5) things before a device can be reclassified:

1. Collect existing scientific information from scientific experts in the medical community and assess the risks and benefits of the medical device type subject to the device reclassification;
2. Convene a meeting of the medical device advisory committee to request input on the device reclassification;
3. Issue a proposed order reclassifying the device type into Class I, II or III;
4. Review and consider comments submitted by the public, and
5. Issue a final order reclassifying the device type into Class I, II or III.

If you are marketing a medical device, compliance with the FDA regulations is important. If you have any questions about compliance with FDA regulations, please contact us at contact@sglawfl.com

1. Enhanced produce safety
2. Preventative controls for human food
3. Best practices and guidelines for animal food
4. The foreign supplier verification program

The FDA is looking towards shifting its focus under the FSMA from after-the-fact responses, or a reactionary approach, to a more proactive, science-based prevention system. For example, the FDA is proposing to augment the water quality testing provisions in the produce safety rules, along with further testing of manure and compost used in crop production. The produce safety rule’s minimum applicable sales requirement, which will exempt very small farms from these new FDA regulations, is also open for public comment; right now it makes farms with less than $25,000 in annual produce sales exempt from its safety requirements.

The FSMA was signed into law in 2011 by President Obama and was the most significant food safety regulation in nearly 70 years. The FSMA seeks to promote better public health and to strengthen the nation’s food safety system. We have previously reported about the FSMA and FDA’s program priorities, including defining “gluten free,” regulating energy drinks, and establishing new rules for displaying nutritional facts.

The FSMA is a very important piece of legislation for companies to consider when developing and marketing their products. For the first time ever, under the FSMA, the FDA has the authority to recall food products. In the past, food distributors and manufacturers recalled food on a voluntary basis and through the urging by the FDA. The FSMA also calls for more frequent inspections of food and facilities. Facilities must also develop detailed preventative controls plans, which should spell out the risks to food safety, what is being done to minimize those risks, how the facility will monitor the risks, and what actions will be taken in the event of a problem.

If a company does not comply with the regulations promulgated under the FSMA, the FDA has a number of enforcement options. In addition to mandatory recalls, the FDA, under the FSMA, has expanded administrative detention of products that are potentially in violation of the law, can suspend the registration of facilities that pose a reasonable possibility of adverse health effects, and mandates increased recordkeeping for “high risk” foods. With this new authority, the FDA can suspend food facility registrations and prevent companies from producing and selling their products, like they did with a peanut butter factory in New Mexico.

The FSMA has the opportunity to change the landscape of food industry regulations. To read more about the FSMA, click here. It is important for any company in the food industry to ensure that they are complying will each new regulation. Failing to do so can mean having your company shut down. For that reason, it is important to have an understanding of your requirements under the law with respect to FDA regulations.

If you have any questions about the proposed rules, the FSMA, or compliance with other FDA regulations, please contact us at contact@sglawfl.com

The major changes from the old rule to the new rule are outlined here. The new rule changes the iconic “nutrition facts” panel design to emphasize parts of the label that reflect current public health concerns like obesity, diabetes, and cardiovascular disease. The new “nutrition facts” panel on labels would look like this, with the text displaying the calorie count enlarged, the percentage of daily value moved to the left side, and changing the footnote to better explain the percent daily value of certain essential nutrients.

The new rule also makes changes that reflect a better understanding of food and nutrition science. When the nutrition facts panels on labels were first introduced more then 20 years ago, the amount and quality of information regarding diet and foods were not as expansive as they are today. For example, the FDA’s new food labeling rule and updated nutrition facts panel would eliminate the “calories from fat” from the label since research has resoundingly shown that the type of fat is more important than the amount alone.

In addition, according to the FDA, the FDA’s new food labeling rule would better reflect the eating habits of the American public. The Agency notes that the rule, if implemented, will require packaged foods that are typically consumed in one sitting to have their serving size labeled as one serving, instead of more than one serving. According to the FDA, the change in serving size will help more accurately reflect consumer behavior. For an example of this new serving size rule, the FDA has published an info-graphic that illustrates this shift in consumers’ eating habits, addressing the need for changes in serving sizes.

The new rules apply to packaged foods. However, like other FDA labeling rules, the new nutrition labeling regulations will do not extend to foods served at restaurants. Food manufacturers will have two (2) years after the rule’s effective date to come into compliance with all of the new regulations. According to the FDA, the rule has a one time initial cost to the industry of $2.3 billion, but the rule is expected to bring $21 to $31 billion in cumulative benefits to consumers over the next 20 years.

As with all FDA regulations, it is important to maintain compliance with these rules to avoid adverse Agency action or other delays in the manufacturing and distribution chain. Failure to comply with FDA regulations can result in warning letters, delays in importation, injunctions, or other adverse action, which ultimately can prevent your company from doing business in the United States. Accordingly, remaining knowledgeable about new regulations and implementing measures to ensure compliance are important when dealing with FDA-regulated products.

If you have any questions about the changes to the nutrition facts panels, FDA labeling regulations or compliance with other FDA regulations, please contact us at contact@sglawfl.com

Similar to tobacco products previously regulated by the FDA, the new regulations would require product manufacturers and marketers, including marketers of e-cigarettes, to follow certain guidelines, such as the following:

• FDA registration and reporting of product information
• Certain new tobacco products can only be marketed after a full FDA review
• Free samples cannot be distributed
• Only scientifically proven, direct claims of a decreased health risk, i.e., “smoking e-cigarettes is safer than traditional cigarettes”,  can be made where the FDA is able to verify that the evidence meets a certain level of scientific support

Additionally, the new proposed rules will include certain restrictions on newly-regulated tobacco related products, including e-cigarettes, that apply to marketing and sale of previously-regulated tobacco products, such as the following:

• Product packaging must list health warnings
• Identification and minimum age requirements in order to prevent underage purchases
• Products cannot be sold in vending machines unless the machine is located in a facility does not allow underage youths

The full text of the proposed regulations may be accessed here.

Although new tobacco products like e-cigarettes are not subject to current, final regulations pertaining to other tobacco products, the agency is working hard to gain control over these items, as illustrated through the proposed rule. If and when the regulations pertaining to e-cigarettes and other new tobacco products are finalized, importers and marketers of these products will be required to comply with the various requirements in order to ensure that their products may be marketed in a manner consistent with federal law. Accordingly, product registration and changes in marketing, including revisions to current labeling for e-cigarettes and the like, may be necessary in order to continue doing business in the United States.

If you have any questions about the FDA’s proposed tobacco product regulations or how you can maintain compliance with FDA regulations, please contact us at contact@sglawfl.com.

The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above, these products are regulated as OTC drugs, etc., as opposed to soaps generally, which are typically regulated as cosmetics by the FDA. As far as the ingredients found in these antibacterial products, the FDA notes that new data suggests that long-term exposure to certain active ingredients—primarily triclosan and triclocarban–in antibacterial products poses health risks such as hormonal effects and resistance to antibiotics. Also, according to the FDA, there is no evidence that antibacterial soaps and hand washes are more effective at preventing illness and reducing infection than plain soap and water.

If finalized, the rule would require manufacturers to submit additional evidence that the active ingredients in antibacterial soap and other products are safe for repeated daily use and provide a clinical benefit as compared to non-antibacterial soap and water. Specifically, the risk must be balanced by the clinical benefit to establish that the OTC antibacterial active ingredients are generally recognized as safe and effective (GRASE) for their intended use. Otherwise, to continue marketing the products, manufacturers would need to remove the antibacterial active ingredients from the product and the antibacterial claims from the product’s labeling. Accordingly, if finalized, the rule would require both formulation and labeling changes for those companies marketing these products.

In sum, the proposed rule will be available for comment for 180 days, until June 16, 2014, with a concurrent one-year period for companies to submit new data and information. If you have any questions about this announcement, GRASE status, or compliance with any FDA regulations pertaining to cosmetics or OTC drugs and need a food and drug (FDA) lawyer, please contact us at:  contact@sglawfl.com.

The FDA has authority to regulate tobacco products pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009. The use of menthol in cigarettes, however, is currently exempt from restrictions applicable to other flavors in cigarettes. For example, menthol is an exception under Section 907(a)(1)(A) of the FDCA, which otherwise prohibits the marketing and sale of cigarettes that contain a characterizing flavor as a constituent or additive.

As the FDA explains, prospective regulatory options include establishing tobacco product standards, restricting the sale and distribution of menthol cigarettes, and any other appropriate actions. Particularly, the FDCA provides the FDA with authority to establish a tobacco product standard, amend an existing product standard, or restrict the sale and distribution of a tobacco product if it is appropriate for the protection of public health.

The agency will consider all comments, data, research, and other information submitted in response to the ANPRM, available for public comment until September 23, 2013, in making its decision. The FDA will also look to scientific studies, including its “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes,” which is provided for comment here. The preliminary evaluation is the FDA’s independent analysis of the association between menthol cigarettes and various outcomes including initiation, addiction, and cessation.

In sum, if the FDA does decide to issue a rule, the next step will be a Notice of Proposed Rulemaking. If you have any questions about the FDA’s regulation of tobacco products or the rulemaking process, please contact us at: contact@sglawfl.com.