FDA warns Rocky Fork Formulas

Rocky Fork Formulas Inc. has a laundry list of problems with drug claims, misbranding and dietary supplement good manufacturing practices, according to a May 13 warning letter from the Cincinnati District of FDA's Office of Regulatory Affairs. ORA stated the Westerville, Ohio, firm made claims for its products including this for a supplement branded Angio Fin: “It is an excellent source for the glucosamine sulfate and chondroitin sulfate that are commonly used in rebuilding arthritic joints … It is also used in conditions that involve angiogenesis. This includes 'wet' macular degeneration. There is currently a study being performed to determine its effectiveness in tumor growth.” ORA's inspections in May and August 2015 of the firm's facility also found GMP violations including failing to document control and return processes and test for ingredient identity. Misbranding problems included stating inadequate directions for the intended use and failing to list ingredients on labels and to include an address or phone number for reporting adverse events. Rocky Fork's response to ORA officials form 483 findings indicated the firm was in the process of becoming compliant with the indicated violations but did not provide information on what steps it was taking, according to the warning.

Warning letter for Beauty & Health International

Beauty & Health International Inc. makes drug claims including “improve recovery from extreme stress and illness like burn, surgery, and cancer” for its dietary supplements and failed to establish specifications for its manufacturing processes, the Los Angeles District of FDA's Office of Regulatory Affairs says in Feb. 5 warning letter. The Garden Grove, Calif., firm's facility was inspected in August and its website in October 2015, ORA officials said in a letter that also listed misbranding problems including labels written in two languages but without all necessary information in both languages. For supplement brands including Dr. Immune H-100 and Nopal with Garlic, Beauty & Health International made drug claims such as “Essential oil with proven natural antiseptic against a wide range of bacteria and fungi” and "a face whitening cream that contains alpha hydroxy acid and a fading agent to help lighten skin." ORA noted good manufacturing practices problems at the firm's facility including failing to establish required specifications for points, steps or stages in the process where control is necessary and to establish written procedures for the responsibilities of quality control operations. The warning was issued after the firm's response failed to present "documentation that indicates you have begun an effective corrective action plan to bring your firm into compliance," ORA stated.

DXM age-restriction bill in Senate

Momentum could be forming for establishing a nationwide age restriction on sales of nonprescription drugs containing dextromethorphan as a bill is introduced in the Senate matching one already introduced in the House. Sens. Bob Casey, D-PA, and Lisa Murkowski, R-AK, on May 26 introduced the DXM Abuse Prevention Act, S 2994, to ban sales of DXM-containing OTC drugs to consumers under 18 years old. The same legislation, HR 3250, was introduced in July 2016 in the House by Reps. Bill Johnson, R-OH, and Doris Matsui, D-CA, and received approval by the Subcommittee on Health in April. While bills introduced in both chambers by Democrat and Republican members could signal a spark of interest in making the change, the proposal has been made without success in Congress for more than 10 years. The industry concern is that without a nationwide policy, rules on DXM sales will vary across the country and within states as state and local governments potentially enact their own regulations ([A#05160411006]).

Choline in Nutrition Label update

The first Nutrition Facts label update in 20 years includes asking firms to voluntarily label choline to help consumers identify the nutrient, according to FDA's May 27 Federal Register notice publishing the final rule on the label. The agency recommends a reference daily intake for choline of 550mg. The update to the label will make it “easier for consumers to make informed choices about what they're eating,” according to the agency's blog. New Hampton, N.Y., firm Balchem Corp., which produces choline, microencapsulation and chelated mineral technology, said on May 24 that choline is associated with heart health, improved liver function, maternal and fetal health, child development, cognition and performance. The final rule also includes the addition of information about added sugars, a point that inspired numerous comments submitted by food and dietary supplement firms when a supplemental proposed rule was published last summer ([A#05150803001]). The final rule is effective July 26 and allows two years for compliance.

Mosquito band marketer settles with FTC

Viatek Consumer Products Group Inc. and owner and President Lou Lentine settle Federal Trade Commission charges of making deceptive claims for Viatek Mosquito Bands and of violating a 2003 administrative order prohibiting Lentine from making product claims without competent and reliable evidence as support. According to FTC's February 2015 complaint in the US District Court for the Eastern District of Tennessee, the firm marketed the wristbands containing mint oil directly to consumers and through retailers, including the home shopping channel HSN, claiming the product protected users from mosquitoes with a “vapor barrier” that extended 5 feet. However, the Chattanooga, Tenn., firm could not back up the claims and FTC alleged it took advantage of consumers' concerns about exposure to the Zika virus. The proposed settlement requires the firm to have competent and reliable scientific evidence in future claims about benefits of pest control products, prohibits it from violating the 2003 order and imposes a $300,000 fine.

$2.2bn in retail sales of weight loss products

The retail market led the direct sales and online markets in weight loss product sales worldwide in 2015 with $2.21bn, technology research and advisory firm Technavio said in a recent report. The London firm's May 25 release said the direct sales segment's total was $624.9m, while online sales reached 607.2m. The market for weight loss products worldwide is anticipated to reach $4.79bn by 2020, with North America, currently accounting for more than one-third of all weight loss product sales, a major contributor, Technavio said.

FTC workshop on ad disclosures

The Federal Trade Commission schedules a public workshop on Sept. 15 to examine the testing and evaluation of disclosures that companies make to consumers for ad claims and on privacy practices and other topics. FTC on May 24 said the “Putting Disclosures to the Test” workshop is aimed at encouraging and improving the evaluation and testing of disclosures. The event, open to the public, will be held at the Constitution Center in Washington.

BiPro signs pole vault champ

Sports supplement marketer BiPro USA, signs professional pole vaulter Kaitlin Petrillose, who is competing at the 2016 US Track and Field Olympic Team Trials, to represent its brand. Petrillose. a pole vault record-holder at the University of Texas, joins long-distance runner Jordan Hasay as a Bi-Pro representative competing for a spot in the 2016 Olympics, the Eden Prairie, Minn., firm, a division of Agropur Inc., said on May 25.

Herbalife Olympics sponsorship

Herbalife Ltd. is the official sponsor of National Olympic Committees for Costa Rica, Israel, Italy and Vietnam during the Rio 2016 Olympics and Paralympic Games and will support more than 65 from 16 countries. The Los Angeles-based direct seller on May 24 said each athlete it sponsors will receive sports nutrition products and access to its sports nutrition scientists.

Ascent Protein goes Spartan

Direct seller Ascent Protein LLC is the Official Performance Nutrition sponsor of Spartan Race obstacle racing series through May 2017. The Denver firm owned by Leprino Foods Inc. on May 23 also said it launched a promotion as the "Official Sponsor of Hard Work." At 22 Spartan events, Ascent will sample its protein and identify and reward hard working athletes with Ascent Native Fuel whey protein powder blend protein and merchandise. Native Fuel is made with native whey, which contains naturally higher levels of Leucine, a key amino acid in the stimulation of muscle protein synthesis. Robert Killian, current Spartan Race world champion, is among the athletes Ascent sponsors.

Industry Roundup: Warning Letters, DXM Bill, Nutrition Label Update

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