Health, Beauty And Wellness News: Nature's Bounty Appointment, Healthy Healing Warning, Recalls
This article was originally published in The Rose Sheet
Nature's Bounty adds communications chief
Nature’s Bounty Co.'s communication strategy, including internal and external communications as well as government affairs and corporate social responsibility, is in the hands of Amy von Walter. The Ronkonkoma, N.Y., nutritional, health and wellness product manufacturer and retailer on Aug. 22 said von Walter was appointed chief communications officer, reporting to President and CEO Paul Sturman.
Von Walter comes to Nature’s Bounty from Toys“R”Us, where she was executive vice president of global communications and customer care and president of its Children’s Fund. She previously held communication leadership positions for entertainment gear and appliances chain Best Buy, medical device firm Medtronic PLC, mass-merchandise retailer Target and the US Department of Homeland Security.
Healthy Healing's GMP plans sway FDA before warning on claims
A Minnesota herbal remedy provider assuaged FDA concerns about its manufacturing practices following an inspection in March and April but couldn't deter the agency from warning it about drug claims for some of its products. Healthy Healing Enterprises Inc., of Eden Prairie, made claims for its Crystal Star brand Women's Best Friend and Para Purge supplements on its website and on product labels, according to an Aug. 14 warning letter from FDA's Office of Regulatory Affairs West Division 1 in Minneapolis. The violative claims that render the products unapproved new drugs under FDA regulations included “Goldenseal Root … a supreme anti-microbial” and "Red Raspberry … helps normalize bleeding" for Women's Best Friend and "Neem leaf inhibits organism growth" and “Black walnut hulls … purgative help for intestinal worms" for Para Purge.
The letter also explains that Healthy Healing Enterprises' responses in April and May swayed ORA officials from warning the firm about good manufacturing practices problems observed during the agency's inspection and noted in a form 483 submitted to the firm. Healthy Healing Enterprises stated it "re-trained employees on receiving, reviewing, and documenting procedures," and has "implemented an updated specification review and documentation of products received at" its facility and a new retention sample and pest control procedures. Its second response included a draft manufacturing quality agreement, a pest control standard operating procedures and inspection log and a new receiving procedure and release form stated that it planned to develop a supplier qualification SOP before July. Additionally, Healthy Healing Enterprises plans to review and update all labeling and marketing materials before April 2019, according to the warning. ORA said agency officials will evaluate the firm's GMP updates at a later inspection.
King Bio recall expands, Avalon cosmetics on recall
Homeopathics firm King Bio Inc. has significantly expanded its voluntary recall of Dr. King's brand products after some manufactured between August 2017 and April 2018 tested positive for microbial contamination. The Asheville, N.C., firm on Aug. 22 announced 32 additional products on recall, accounting for a total of 74 lots, after announcing in July that it was recalling three products. Products labeled for children account for the largest part of the latest recalls, which also include 13 products indicated for use by medical professionals, not as consumer health products. The firm said it has not received any reports of adverse events linked to the products on recall. Its July announcement identified the microbial contaminants found its products as Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans. (Also see "Dr. King's Homeopathics Recalled; MyNicNaxs Starts Recall 3 Months After FDA Shutdown" - HBW Insight, 23 Jul, 2018.)
In other health, beauty and wellness product recalls, FDA's latest update on recalls that have been classified includes supplement products from Hard Eight Nutrition LLC and Confidence U.S.A. Inc. and Avalon cosmetic and alba sunscreen products from [Hain Celestial Group Inc.](see table linked below).
FDA Health, Beauty And Wellness Recalls