In Brief: Hormel Buys CytoSport, FDA Warns On Drug Claims, Mira Health Consent Decree

Hormel flexes Muscle Milk for protein; Hangover prevention claims are disease claims; Mira Health cannot resume supplement production without FDA permission; Batch production records require details; Laclede needs drug approval for vaginal products and U.S. & Korea ink organic equivalency agreement.

Hormel flexes Muscle Milk for protein

Hormel Foods Corp. expands its protein portfolio beyond canned meat and peanut butter with the $450 million acquisition of CytoSport Holdings Inc., the maker of Muscle Milk sports nutrition drinks, bars and proteins. Private equity group TSG Consumer Products announced June 30 it is selling its stake in CytoSport to Hormel seven years after investing in CytoSport, during which time the firm won multiple awards for innovation. The father and son founders of Benicia, Calif.-based CytoSport, Greg and Mike Pickett, also sold their interest to Hormel and will remain involved in the daily business.

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Muscle Milk sports nutrition drinks, bars and proteins will be part of Hormel Foods' protein portfolio through its $450 million acquisition of CytoSport Holdings.

Hormel expects the deal to close within 30 days and to add about 5 cents per share to its fiscal 2015 earnings. The Austin, Minn.-based firm said CytoSport's 2014 sales are expected to be about $370 million. Hormel already operates a business that sells ingredients including whey-protein concentrate to food and beverage makers. The Picketts founded CytoSport in 1998 and launched Muscle Milk in 2000 in the protein powder category and have since expanded the brand into ready-to-drink products distributed by PepsiCo Inc.A former Pepsi Bottling Group executive who has worked as a TSG consultant, Rob King, was named CytoSport CEO in June 2013, succeeding Mike Pickett.

Laclede needs approval for vaginal products

Laclede Inc., allegedly illegally distributed multiple OTC prebiotic vaginal products without FDA approval, according to a complaint the Department of Justice filed for FDA on June 25. The complaint seeks to block the Rancho Dominguez, Calif., firm from distributing Luvena Prebiotic Vaginal Moisturizer and lubricant, Luvena Prebiotic Enhanced Personal lubricant, Luvena Prebiotic Feminine Wipes and Luvena Prebiotic Daily Therapeutic Wash until the firm has approved new drug applications for the products. Alternatively, the firm can remove all drug claims from the products’ labels and marketing, according to a July 1 release. The agency says it has told Laclede repeatedly since 2010 that the firm needs pre-market approval for products marketed as drugs. The prebiotic products launched in 2012 (Also see "NACDS Marketplace In Brief" - Pink Sheet, 23 Jul, 2012.).

Hangover prevention is a disease claim

Claims to provide hangover relief from beer, wine and liquor cause Alcohol-X Hangover, which is marketed as a supplement, to be an unapproved new drug, FDA tells Bhelliom Enterprises Corp. in a May 29 warning letter. Curing and preventing hangovers is a condition that is not amendable for self-diagnosis and treatment and directions for use cannot be written, FDA says. The Boca Raton, Fla., firm’s Thermolene Body Sculptor product also is an unapproved new drug because marketing material cites two studies of the product in obese women. Because obesity is a disease, FDA says the inclusion of the citations in marketing materials demonstrates the agency intended to sell the product as a treatment for a disease. FDA also cited the firm for good manufacturing practice violations and improper labeling, including missing information from the Supplement Facts box and including an ingredient on the label that was not in the product.

Mira Health needs FDA OK to resume production

Mira Health Products Ltd. must recall and destroy, under FDA’s supervision, all unexpired drugs and supplements it has made since Aug. 1, 2010, according to a consent decree signed July 1 by a federal judge in New York. The firm is out of business and cannot resume operations until FDA determines that it complies with all applicable food and drug regulations, the agency announced July 2. FDA sought the injunction after warning consumers in July 2013 not to use the Farmingdale, N.Y., firm’s Healthy Life Chemistry By Purity First B-50. Adverse event reports about the product prompted FDA testing, which revealed two undeclared anabolic steroids in the product (Also see "In Brief: NAD trims BPI claims, formula price-fixing in China, FDA warns Formulife and identifies spiked supplements, NBTY’s consumer redress" - Pink Sheet, 12 Aug, 2013.). In August 2013, Mira recalled all supplements made from June 2010 through May 2013. The consent decree against is the second in a week FDA announced in the supplement sector (Also see "In Brief: CHPA Disagrees With FDA Warning; Adulterated Supplements Enforcement; DASCA Support Sought" - Pink Sheet, 30 Jun, 2014.).

Batch production records require details

Batch production records require more than the date of bottling under the dietary supplement good manufacturing practices, FDA tells Wyldewood Cellars Inc. in a June 23 warning letter. The agency says BPRs must include the identity of the equipment used to make the batch; the date and time of equipment maintenance and sanitizing; the unique identifier for each component, packaging and label; the identification and weight of each component; the actual and theoretical yield of the product; and test results, among other elements. The Peck, Kan., firm also failed to have a written master manufacturing record for each product, set specifications, document equipment calibration and sanitization and establish written procedures to review complains, among other GMP violations, FDA said. An agency inspector also witnessed unhygienic practices, including an employee who mixed product immediately after taking out the trash without washing his hands. Other employees failed to wear hairnets.

U.S., Korea ink organic equivalency pact

Products that meet U.S. standards now can be labeled as organic in Korea without obtaining separate certification, paying extra fees or undergoing additional inspections, the U.S. Department of Agriculture announced July 1. The U.S., likewise, will recognize organic labeling that meets Korean standards through the equivalency program, a first for Korea. The deal will eliminate access barriers that were particularly difficult for small to medium-sized organic product firms. The arrangement is similar to those the U.S. has with Canada, the European Union and Japan, and it will cover organic condiments, cereal, baby food, frozen meals, milk and other processed products, USDA said.