FDA Issues Final Rules Vending Machines and Restaurant Menu Labeling Requirements

Caloric Disclosure Final Rules Vending Machines and Restaurant Menu Labeling

Introduction and Quick Summary: FDA just released two final rules regarding caloric disclosure for final publication in the Federal Register. The rules were proposed in April 2011 under section 4205 of the Affordable Care Act. The final rule will be issued on December 1, 2014 and the effective date is December 1, 2015 to afford vending machine operators and affected restaurants time to comply. The final rule summaries issued by FDA are below as well as a direct link and issue to consider.

Vending machine final rule: Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemption.

Menu labeling final rule: Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines. A final rule was December 1, 2014 is to assist consumers by requiring the availability of point of purchase nutrition caloric information prior to purchasing the food item. (Proposed Rule April 6, 2011).

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. The purpose of the final rule also published December 1, 2014 is to implement the menu labeling provisions of the Affordable Care Act.

Links to overview and final rules.

http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm248732.htm

Here is What FDA Summarized About These Caloric Disclosure Rules

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm423987.htm

The U.S. Food and Drug Administration has finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments and vending machines to help consumers make informed decisions about meals and snacks.The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. A restaurant or similar retail food establishment is generally defined as a retail establishment that offers for sale restaurant-type food, which is generally defined as food that is usually eaten on the premises of the establishment, while walking away, or soon after arriving at another location. Examples of restaurants and similar retail food establishments include sit-down and fast-food restaurants, bakeries, coffee shops and grocery and convenience stores. The menu labeling final rule also requires calorie labeling for certain alcoholic beverages and certain foods sold at entertainment venues such as movie theaters and amusement parks. The FDA also clarifies in the menu labeling final rule that certain foods purchased in grocery stores or other retail food establishments that are typically intended for more than one person to eat and require additional preparation before consuming, such as pounds of deli meats and cheeses and large-size deli salads, are not covered.To help consumers understand the significance of the calorie information in the context of a total daily diet, the FDA is requiring a succinct statement that says, “2,000 calories a day is used for general nutrition advice, but calorie needs vary” to be included on menus and menu boards. The menu labeling final rule also requires covered establishments to provide, upon consumer request, written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein.

Restaurants and similar retail food establishments that are covered, including those that voluntarily register with FDA to comply with the menu labeling requirements, will have one year from the date of publication of the menu labeling final rule to comply with the requirements.

The vending machine final rule requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exceptions. Vending machine operators that are covered, including those that voluntarily register with FDA to comply with the vending machine labeling requirements, will have two years from the date of publication of the vending machine labeling final rule to comply with the requirements.

Conclusion The caloric disclosure is a step in the correct direction since the obesity rate has again risen in the United States.

Recommendation Is caloric disclosure sufficient in terms of right to know?

Seizure and Consent Decree Unapproved Pharmaceuticals

Ascend Laboratories…Seizure and Consent Decree

The following is a recent FDA issued press release about Ascend Laboratories, LLC. The court for the South District of Ohio entered the consent decree for permanent injunction against Ascend Laboratories, LLC. Besides the seizure action, the company is enjoined from manufacturing and distributing unapproved drugs until Ascend obtains approval from FDA. The action was based on inspections which revealed that the company was manufacturing approved drugs.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418867.htm

Federal judge approves FDA consent decree with Ascend Laboratories

For Immediate Release: October 14, 2014 A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The U.S. Department of Justice filed the consent decree on behalf of the U.S. Food and Drug Administration.

The consent decree requires Ascend Laboratories to post bond for the release of their unapproved drug products seized by U.S. Marshals in May 2014, which the company is then responsible for destroying under the FDA’s supervision. The drugs were seized at a warehouse in Cincinnati operated by Masters Pharmaceutical, Inc. (doing business as RXTPL).

In addition, the consent decree prohibits Ascend Laboratories and all other associated persons who act in concert with the company from manufacturing and distributing unapproved drugs until the company obtains FDA approval, including: Pramoxine-HC Otic Drops; Hydrocortisone Acetate Suppositories 25 milligrams; Urea Cream 39%; Urea Cream 40%; and Urea Lotion 40%.

“Manufacturing and distributing unapproved prescription drugs puts patients’ health at risk since they have not been found to be safe, effective or made using quality manufacturing practices,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Companies that fall short of our requirements risk FDA action to stop the distribution of their products.”

The FDA inspected Ascend Laboratories’ New Jersey facility in November 2013 and Masters Pharmaceutical’s Cincinnati warehouse in February 2014. The inspections revealed that Ascend Laboratories was marketing drug products without FDA approval and adequate directions for use.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Corporate Accountability Food Safety Felony Conviction

Corporate Executive Liability Food Safety—Felony Conviction

Peanut Corporation of America Background

The former owner of Peanut Corporation of America Peanut Corp.) Stewart Parnell was convicted on September 19, 2014 of conspiracy and other charges in connection with a deadly salmonella outbreak that occurred in 2008-2009. According to the Centers for Disease Control and Prevention, nine people died and over 700 others became ill in 2008-09 after eating peanut butter or other products prepared at the company’s plant in Georgia. Mr. Parnell, was found guilty on several counts, including wire fraud and obstruction of justice. The indictment was centered on a conspiracy to conceal that several of Peanut Corp.’s products were contaminated with salmonella. Others involved and convicted included the brother of Stewart Parnell, Michael Parnell, a food broker who worked on behalf of Peanut Corp. and the quality assurance manager, Mary Wilkerson, for obstruction of justice. Two other former Peanut Corp. employees has previously pled guilty to multiple charges.

Prosecutors alleged that Peanut Corp. not only defrauded customers but also defrauded several national food companies by failing to inform them about the presence of food-borne pathogens in laboratory tests, including salmonella. According to prosecutors, in some instances, despite these results, Peanut Corp. officials totally falsified lab results, maintaining peanut products were safe for consumption. Further, at times, the Peanut Corp. failed to even perform testing.

Corporate Liability Significance

Although for years, corporate executives have been charged with misdemeanor offenses under the strict criminal liability theory known as the Park doctrine, this case is distinguishable. The Peanut Corp. case represents a felony prosecution under the Federal Food, Drug and Cosmetic Act. The Peanut Corp. prosecution serves as a wake up call to the regulated food safety industry.

Outcome and Sentencing

Peanut Corp. filed for Chapter 7 bankruptcy protection weeks after the outbreak began. The felony convictions mean the possibility of a extensive prison sentence and fines.

Is Your FDA Regulated Product a Drug, Device or Combination?

Prevor v. United States Food and Drug Administration

Primary Mode of Action Determination is Critical in Combination Product

Introduction: At times, the United States Food and Drug Administration struggles with proper product classification. The case of Prevor v. Food and Drug Administration , D.D.C., No. 1:13-cv-01177 (September 9, 2014) provides a prime example. The major complex issue is whether the product should be classified as a drug, medical device or combination.

About the Product: The form of Diphoterine® Skin Wash (DSW) is a liquid substance in a canister propelled by pressurized gas. Intent is critical in the determination of product classification.

Background: The drug, device and combination product classification issues stem back to 2009. Originally, back in 2009, FDA’s Office of Combination Products classified Prevor’s skin wash product, DSW as a drug primary mode of action rather than as a device as a primary mode of action. See 21 C.F.R. § 3.2(m). FDA found the product had two primary intended purposes using the reasoning “to wash the chemical off the skin and neutralize the chemical that is on the skin.”

Prevor I: In 2012, the District Court found the FDA’s action classifying the DSW product as a drug primary mode rather than a device as a primary mode was both arbitrary and capricious. The District Court vacated the FDA’s decision to classify DSW as a drug-device combination product with a “drug” primary mode of action. Yet, Prevor, a device maker, has vigorously argued that the product is a device and not a drug. Alternatively, if deemed a combination product, the primary mode of action according to Prevor would be a device. Prevor v. Food and Drug Administration (Prevor I ), 895 F.Supp.2d 90 (D.D.C.2012)

Prevor II: Fast forward to 2014 and this time, the District Court for the District of Columbia again vacated FDA’s decision to designate Prevor’s DSW as a drug-device combination product with a “drug” primary mode of action. Ultimately FDA reached the same conclusion, yet found only one primary purpose: “to help prevent and minimize accidental chemical burn injuries.” The Court clarified that “as the record now stands, the Court cannot affirm FDA’s classification decision because it was based on an erroneous and unreasonable interpretation of the law.” . The Court rejected Prevor’s argument to classify the product as a medical device and or a combination product with a medical device as the primary mode. Yet, the District Court found that FDA action arbitrary and capricious.

Court Leaves Door Open: FDA must consider the issue yet again. In essence, the Court left the door open for FDA to reconsider the issues again; that is, the court stated that the FDA “could find that DSW should be classified as a drug-device combination product with a drug mode of action if it also adopts a plausible construction of the relevant statutory language.” Chemical action and intent remain critical as the court set forth that classification is dependent on whether its chemical action will prevent and minimize chemical burns. Therefore, the court “left open” and remanded the designation decision to the FDA.

Next Steps: There is no definite conclusion nor is there finality. FDA will need to reconsider the issue and provide a basis in accordance with what the District Court stated about a “plausible construction of the statutory language”. No doubt the legal saga will continue.

Power Morcellators, Informed Consent, Laparoscopic Surgery, and Protocols …

FDA ACTION

Power Morcellator

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

Paying the Price of Not Being Fully Informed… Update

Recently, the topic of laparoscopic hysterectomy or myomectomy for the treatment of fibroids and a procedure known as morcellation has become very controversial. What may seem like an everyday simple surgical procedure has become for some women the unwanted end result of invasive cancer.

The issues are quite complex. The purpose of this blog is to simply point out a few concepts to consider in the decision making process of whether a woman should undergo a full traditional surgical procedure or a laparoscopic procedure. What may seem like a simple choice could potentially become a nightmare with a life changing outcome.

Today, more than ever, noninvasive surgery has become the “protocol” for many procedures. Yet, should it? The simple answer is that it depends on many factors. The single most important factor should be the patient and obtaining a valid informed consent. A valid informed consent should be videotaped. The patient must receive a “Plain English” explanation of the risks and benefits of such procedures.

It might sound “high tech” to use such a device approved by the United States Food and Drug Administration (FDA) and the costs in terms of insurance might be beneficial to the to the insurer and insured. According to FDA: “Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.” MedWatch

Yet, the question remains at what cost?

An excellent example is the removal of fibroids and morcellation without the benefit of a biopsy prior to the morcellation. What this means is if the fibroids are cancerous, the “morcellation procedure” spreads the cancer throughout the patient’s body. How? Power morcellators use extended, tube-shaped blades to cut uterine tissue into little pieces. This permits the surgeon who performs a laparoscopic or minimally invasive hysterectomy, to remove the tissue through a small incision.

Does it all come down to dollars and lack of informed conformed? Apparently so, as the practice continues and is sanctioned in protocols. According to physician Amy Reed: Morcellation is done in at least 11% of the nearly 500,000 hysterectomies are performed each year. See: http://www.usatoday.com/story/news/nation/2014/02/18/hysterectomy-laparoscopic-morcellation-amy-reed/5347093/

Benefit: Easier removal of the uterus and speedier recovery time rather than traditional abdominal surgery which could result in a large scar.

Major Risk: Undiagnosed cancer may be present and the morcellation process spreads the cancer.

FDA Warning, Guidance and Alerts, FDA Medical Device Advisory Committee Recommendations and Lawsuits

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

FDA had issued an alert in April 2014 to discourage the use of power morcellation. Specifically, FDA set forth: “laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee was convened by FDA on July 10 and 11, 2014. The committee discussed the “safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy.” According to FDA the purpose of the committee meetings was to “seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data.” The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices.

http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm Quantitative Assessment of the Prevalence of Unsuspected Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids Summary and Key Findings April 17, 2014 http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589.pdf

See also: “New Cancer Risk Seen From Surgical Tool” in the Wall St. J. (July 23, 2014).

Lawsuits: Yes, lawsuits have been instituted. Yet, are lawsuits the solution? Here are suggestions to prevent what has occurred to date.

Recommendations

Medical Device companies who manufacture the device(s) used in these types of procedures should redesign the product and until that is done conduct a field correction recall of the medical device(s) in question. Ethicon Inc., a unit of Johnson & Johnson, suspended the sales of several of its power morcellators and in July 2014 issued a market withdrawal.
Hospitals should consider a revised protocol and some hospitals have already temporarily banned morcellation until the risk can be more fully evaluated.
Physicians should offer “informed” options to the patient.
Informed consent should be just that- a plain language explanation of the benefits and risks of consenting to this type of procedure.

Stay tuned for more on this critical health medical-legal issue as the FDA Advisory Committee will issue recommendations pertaining to appropriate use, premarket testing, labeling, and other risk mitigations such as containment bags) for these devices.

This blog was written by Roseann B. Termini, Esq. with insight and review by Desencia E. Thomas, M.D.

Internet Pharmacies and Shipper Liability

INTERNET DRUG SALES AND SHIPPER LIABILITY

United Parcel Service “NonProsecution Agreement”

Does a shipper such as FedX or United Parcel Service, INC. (UPS) have a legal duty to refuse to ship drug products to United States customers who obtain controlled substances and prescription drugs without a prescription from “Internet Pharmacies”? UPS agreed in 2013 to a “Nonprosecution Agreement” with the United States Department of Justice in which the company agreed to forfeit $40 million in payments it received from illicit online pharmacies. UPS agreed to institute a compliance program to assure that illegal online pharmacies will not be able to use UPS for shipment. For example, an online pharmacy compliance officer position is responsible to implement, monitor and provide regular reports to UPS’s chief executive officer. According to FDA and the Department of Justice, UPS was on notice since 2004 that Internet pharmacies were illegally shipping prescription through common carriers such as UPS. Yet, despite a compliance program instituted in 2004, it was deemed ineffective. See: UPS Agrees To Forfeit $40 Million In Payments From Illicit Online Pharmacies For Shipping Service

FedEx Corporation Indictment

More recently, FedEx Corporation was charged See: United States v. FedEx Corp., N.D. Cal., No. 14-cr-00380, indictment 7/17/14) /See: FDA FedEx Indictment. The grand jury issued a 15 count indictment . If there is a conviction FedEx could face fines, penalties, forfeiture. Most likely, there would be mandatory compliance parameters as well. See also: FDA News Release.

Wheaton College v. Burwell —A Follow-up to Hobby Lobby

WHEATON COLLEGE V. BURWELL

The United States Supreme Court issued an Order on July 3, 2014 shortly after the Hobby Lobby decision concerning the pending case of Wheaton College v. Burwell.

The Order in part provides: “If the applicant informs the Secretary of Health and Human Services in writing that it is a non- profit organization that holds itself out as religious and has religious objections to providing coverage for contraceptive services, the respondents are enjoined from enforcing against the applicant the challenged provisions of the Patient Protection and Affordable Care Act and related regulations pending final disposition of appellate review. To meet the condition for injunction pending appeal, the applicant need not use the form prescribed by the Government, EBSA Form 700, and need not send copies to health insurance issuers or third-party administrators.

The Circuit Courts have divided on whether to enjoin the requirement that religious nonprofit organizations use EBSA Form 700. Such division is a traditional ground for certiorari. See S. Ct. Rule 10(a).

Nothing in this interim order affects the ability of the applicant’s employees and students to obtain, without cost, the full range of FDA approved contraceptives. The Gov- ernment contends that the applicant’s health insurance issuer and third-party administrator are required by federal law to provide full contraceptive coverage regard- less whether the applicant completes EBSA Form 700.

The applicant contends, by contrast, that the obligations of its health insurance issuer and third-party administrator are dependent on their receipt of notice that the applicant objects to the contraceptive coverage requirement. But the applicant has already notified the Government— without using EBSA Form 700—that it meets the re- quirements for exemption from the contraceptive coverage requirement on religious grounds. Nothing in this order precludes the Government from relying on this notice, to the extent it considers it necessary, to facilitate the provi- sion of full contraceptive coverage under the Act.In light of the foregoing, this order should not be con strued as an expression of the Court’s views on the merits.

The full Order including the dissent by Justice Sotomajor joined by Justices Kagan and Ginsburg is directly linked here: Wheaton College v. Burwell.

Contraceptive Mandate and Hobby Lobby Decision

The Supreme Court decided the case known as “Hobby Lobby”. The direct link to the official opinion follows the Court holding. Page #’s refer to pages in opinion.

Held: As applied to closely held corporations, the HHS regulations imposing the contraceptive mandate violate the [Religious Freedom Restoration Act of 1993] RFRA. Pp. 16–49.

(a) RFRA applies to regulations that govern the activities of closely held for-profit corporations like Conestoga, Hobby Lobby, and Mardel. Pp. 16–31.

(1) HHS argues that the companies cannot sue because they are for-profit corporations, and that the owners cannot sue because the regulations apply only to the companies, but that would leave merchants with a difficult choice: give up the right to seek judicial protection of their religious liberty or forgo the benefits of operating as corporations. RFRA’s text shows that Congress designed the statute to provide very broad protection for religious liberty and did not intend to put merchants to such a choice. It employed the familiar legal fic- tion of including corporations within RFRA’s definition of “persons,” but the purpose of extending rights to corporations is to protect the rights of people associated with the corporation, including shareholders, officers, and employees. Protecting the free-exercise rights of closely held corporations thus protects the religious liberty of the humans who own and control them. Pp. 16–19.

http://www.supremecourt.gov/opinions/13pdf/13-354_olp1.pdf

Social Media, Twitter and FDA Guidance

Social Media, Twitter and FDA Guidances-Prescription Drugs and Medical Devices

FDA just released on June 17 two important draft Guidances for the FDA regulated industry specific to prescription human and animal drugs and medical devices for humans.

Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

The first draft guidance describes how manufacturers, packers and distributors of prescription drugs and devices should present both benefit and risk information within advertising and promotional labeling on electronic and digital platforms that have character space imitations such as Twitter, on the Internet, social media and or other hi-tech settings.

Major Points Articulated by FDA:

Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).

Benefit information should be accompanied by risk information within each individual character-space-limited communication.

If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.

Character Space Limitations such as Twitter:

Risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet); The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product.

A mechanism, such as a hyperlink, should also be provided within each individual character- space-limited communication to allow direct access to a more complete discussion of risk information about the product.

The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform.

Guidance: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

The second draft guidance details how prescription drug and device manufacturers, packers, and distributors should respond, if they choose to do so, to misinformation generated and distributed by independent third parties on the Internet or through social media avenues.According to FDA appropriate corrective action by a company should:

Be relevant and responsive to the misinformation;
Be limited and tailored to the misinformation;
Be non-promotional in nature, tone, and presentation;
Be accurate;
Be consistent with the FDA-required labeling for the product;
Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

The direct links are as follows:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf and

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf

Benefit:

These two important guidances, although in draft format, provide the regulated industry with a more descriptive concept of FDA expectations. Although not legally binding, these draft guidances, unlike previous drafts specific to these issues, provide more direction and clarity to the regulated industry.

POM WONDERFUL LLC v. COCA-COLA CO.

United States Supreme Court Holding: A competitor may bring a Lanham Act claim(s) that alleges unfair competition from false or misleading labels on food and beverage labels regulated under the United States Federal Food, Drug and Cosmetic Act.
Link to Supreme Court opinion is below.
http://www.supremecourt.gov/opinions/13pdf/12-761_6k47.pdf