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FTC Approves Final Order and Consent Agreement with American Guild of Organists

Following a public comment period, the Federal Trade Commission has approved a final order and consent agreement in which the American Guild of Organists agreed to eliminate rules that restrict its members from competing for opportunities to perform.

Announced in March 2017, the agreement between the FTC and the American Guild of Organists resolves the agency’s complaint that the guild’s rules restrained competition and harmed consumers in violation of the FTC Act. Under the guild’s code of ethics, if a consumer wished to have someone other than an “incumbent musician” play at a venue for a wedding, funeral or other service, the consumer was required to pay both the incumbent and the consumer’s chosen musician. The guild also developed and publicized compensation schedules and formulas, and instructed its chapters and members to develop and use regionally applicable versions to determine charges for their services.

The order requires the American Guild of Organists to stop restraining its members from soliciting work as musicians, and to stop issuing compensation schedules, guidance, or model contract provisions for members to use to determine their compensation. The guild must implement an antitrust compliance program, and is required under the order to stop recognizing chapters that fail to certify their compliance with the order’s provisions. The Commission recognizes the guild for taking steps to promptly comply with the proposed order and discontinue the identified practices at the earliest feasible time.

The Commission vote approving the final order was 2-0. (FTC File No. 141 0194; the staff contact is Karen A. Mills, Bureau of Competition, 202-326-2052.)

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about how competition benefits consumers or file an antitrust complaint. Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.

FTC Requires Sherwin-Williams to Divest Assets as a Condition of Acquiring Valspar

Sherwin Williams will sell Valspar’s industrial wood coatings business to Axalta Coating Systems Ltd.

The Sherwin-Williams Company has agreed to settle Federal Trade Commission charges that its proposed $11.3 billion acquisition of Valspar Corporation is likely anticompetitive by selling Valspar’s North America Industrial Wood Coatings Business to Axalta Coating Systems Ltd. The transaction would combine Sherwin-Williams and Valspar, two of the top three industrial wood coatings manufacturers.

According to the complaint, the acquisition as originally proposed likely would reduce competition in the North American market for industrial wood coatings used to make furniture, kitchen cabinets, and building products. The complaint alleges that the combined firm would be likely to exercise unilateral market power, and that the combined firm and the other remaining competitors would compete less aggressively against each other.

Industrial wood coatings, which include stains, topcoats, and sealants, provide higher resistance to abrasion and water than consumer wood coatings, and are often sold to wood-products manufacturers along with on-site technical assistance. Because consumers and builders value the appearance of finished wood, there is no economically viable substitute for industrial wood coatings, according to the complaint. Barriers to entry for new suppliers of industrial wood coatings are high, because of both the large capital costs needed to build a high-volume industrial wood coatings plant, and the reluctance of customers to switch to unproven new suppliers.

Under the terms of the consent agreement, Sherwin-Williams will divest to Axalta two Valspar industrial wood coatings plants, one in High Point, North Carolina, and the other in Cornwall, Ontario. Axalta will also receive the research and development facilities, warehouses and testing facilities of Valspar’s Industrial Wood Coatings Business, as well as customer contracts, intellectual property, inventory, accounts receivable, government licenses and permits, and business records. The consent agreement limits Sherwin-Williams’s use of, and access to, confidential business information pertaining to the divestiture assets.

As one of the leading suppliers of coatings to large automotive and industrial original equipment manufacturers, Axalta is well positioned to operate these assets as an effective competitor that will maintain competition in the markets that would otherwise be affected by the merger.

Further details about the consent agreement – which appoints a monitor to oversee the implementation of the relief and allows the Commission to appoint a divestiture trustee as may be required – are set forth in the analysis to aid public comment for this matter.

The Commission vote to issue the complaint and accept the proposed consent order for public comment was 2-0. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through June 27, 2017, after which the Commission will decide whether to make the proposed consent order final. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice.

NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $40,654.

FDA

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients

AUDIENCE: Family Practice, Consumer

ISSUE: Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk.

These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume this product.

BACKGROUND: Caverflo Natural Herbal Coffee is used as a male enhancement and is packaged in 25 gram black foil packs, UPC 9555671709994. Caverflo.com distributed this product from August 2016 through February 2017. Caverflo Natural Herbal Coffee is consumed as an instant coffee. Caverflo Natural Herbal Coffee was distributed nationwide to consumers via internet at Caverflo.com.

RECOMMENDATIONS: Consumers with questions regarding this recall can contact Caverflo.com at coffeekingb@yahoo.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Please see the complete MedWatch Safety Alert at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560710.htm

A Safety Information and Adverse Event Reporting Program

Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle

AUDIENCE: Family Practice, Health Professional, Consumers

ISSUE: AstraZeneca is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of Brilinta 90mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca.

Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure which is more common when Zurampic is given alone as it should be used in combination with a xanthine oxidase inhibitor. Brilinta has a warning in its prescribing information regarding discontinuation of the medicine. Missed doses of Brilinta increases the risk of heart attack and stroke. People who are treated with a stent and miss doses of Brilinta have a higher risk of getting a blood clot in the stent, having a heart attack, or death. Patients should not stop taking Brilinta without talking to their prescribing doctor. To date, AstraZeneca has not received any reports of adverse events related to this recall.

BACKGROUND: This is limited to one lot (Brilinta lot #JB5047) of professional sample bottles containing eight tablets of Brilinta 90 mg distributed to physicians in the US between March and April of 2017. Other forms and dosage strengths of Brilinta, including medicine obtained via US retail or mail order pharmacies, are not affected by this voluntary recall. This recall does not affect Zurampic.
Brilinta is indicated to reduce the rate of CV death, heart attack and stroke in patients with acute coronary syndrome (ACS) or a history of heart attack. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. Zurampic is a prescription medicine used together with a xanthine oxidase inhibitor such as allopurinol or Uloric in adults with gout who still have a high uric acid level.
Brilinta 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with 90 above a T on one side of the pill. Zurampic tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with LES200 on one side of the pill.

RECOMMENDATION: AstraZeneca is notifying physicians by recall letter and is arranging for return of all recalled products. Consumers that have medicine which is being recalled should contact their physician.

Complete and submit the report Online: www.fda.gov/MedWatch/report

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Please see the complete MedWatch Safety Alert at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560786.htm

Recall on Fewer Than 225 Ava's Brand Organic Cashews Roasted & Salted 8 oz. Tubs in NJ, NY, PA and CT

05/26/2017 09:38 AM EDT

Hampton Farms is voluntarily recalling Ava's brand Organic Cashews Roasted & Salted 8 oz. tubs distributed in New Jersey, New York, Pennsylvania and Connecticut. We have been notified by our cashew supplier that the cashews used have the potential to be contaminated with Listeria monocytogenes. No confirmed illnesses have been reported to public health authorities to date.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Center for Food Safety and Applied Nutrition

Constituent Update

FSVP: As Compliance Date Nears, Key Facts for Importers

May 26, 2017

The first major compliance date for importers covered by the Foreign Supplier Verification Programs (FSVP) rule arrives on May 30, 2017. FSVP is one of the seven foundational rules of the FDA’s Food Safety Modernization Act (FSMA). A central tenet of that law is that the same preventive food safety standards apply to food consumed in the U.S., regardless of where the food is produced. FSVP achieves this by requiring importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.

In a Q&A interview, Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine at FDA, explains what importers facing this May compliance date need to know and what’s ahead as FSVP implementation moves forward.

For More Information:

Caverflo.com Issues Voluntary Nationwide Recall of Caverflo Natural Herbal Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk

05/25/2017 09:00 PM EDT

Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

California Sun Dry Foods Announces a Voluntary Recall of Mislabeled California Sun Dry Sun-Dried Tomato Pesto Due to Undeclared Almond and Milk Allergen

05/25/2017 08:09 PM EDT

California Sun Dry Foods today issued a voluntary recall of California Sun Dry Sun-Dried Tomato Pesto because of a potentially incorrect back label on some jars. This mislabeling incident resulted in undeclared allergens (Almonds and Milk). People who have an allergy or severe sensitivity to tree nuts and milk run the risk of serious or life-threatening allergic reaction if they consume this product.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

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