Congress Recommends Public Rulemaking In Puerto Rico: Health & Wellness Industry News Roundup

Boehringer Ingelheim agrees to divest five types of animal products to close its deal that sends its consumer products business to Sanofi; "healthy" label use comment extended; and more news in brief.

Congress expects public supplement rulemaking in Puerto Rico

The Congressional Task Force on Economic Growth in Puerto Rico doesn't recommend repealing a proposal in Puerto Rico to subject dietary supplement retailers and distributors to extensive fees and regulations, but advises the commonwealth to conduct public meetings before imposing the rule. The Puerto Rico Department of Health put the proposed regulation, Administrative Order 346, on hold for 120 days in September following supplement industry trade groups' lobbying with the island's lawmakers, who instructed the department to draft a new proposal and to follow a public rulemaking process. The trade groups also asked the task force to review the proposed rule, which they say does not acknowledge that supplements are not regulated as drugs in the US. (Also see "Puerto Rico Supplement Rule Still Percolates: Health And Wellness Industry News Roundup" - HBW Insight, 18 Oct, 2016.) The task force, in its final report covering a range of economic and regulatory topics published Jan. 6, said if the Puerto Rico department replaces the order, it recommends that the agency "follow through on the [department] Secretary’s pledge to hold public hearings on the proposed regulation so that all stakeholders, whether they support or oppose administrative action, can provide comments." The report also notes that a challenge to a regulation can be made through " the local or federal courts in Puerto Rico, just as it could in any other US jurisdiction."

'Healthy' in labeling comment period extended

FDA extends to April 26 the comment period for comments on the use of the term “healthy” in labeling of food products. The agency announced in a Dec. 30 Federal Register notice that the docket opened in September for comments on the term “healthy” generally and as a nutrient content claim in the context of food labeling and it is extending the comment period to accommodate stakeholders who asked for more time beyond the initial Jan. 26 deadline. The action is consistent with FDA’s recently released 2016-2025 Foods and Veterinary Medicine Program’s strategic plan with specific goals for nutrition and other planned and recent activity, including the issuance of final guidance updating nutrition labeling regulations.

Boehringer to divest animal products to close Sanofi swap

Boehringer Ingelheim GMBH agrees to divest five types of animal health products marketed in the US to settle the Federal Trade Commission's finding that the German's firm's ownership of the Merial animal products business in a swap with Sanofi's would be anticompetitive. In a Dec. 28 release, FTC said it filed a complaint arguing that Boehringer's control of Merial would harm competition in the US for vaccines for pets and parasite control products for cattle and sheep. The proposed consent order is subject to public comment through Jan. 27. Under the proposed swap announced in June, Boehringer will acquire Sanofi's Merial, valued at $13.53bn and Sanofi will acquire Boehringer’s consumer health care business unit valued at $7.98bn as well as cash compensation of $5.54bn. (Also see "Sanofi CEO Sets Growth Target For Consumer Health Business" - Pink Sheet, 30 Oct, 2016.) Sanofi will gain Boehringer's consumer products business with predominantly OTC drugs but also including Pharmaton multivitamin and mineral supplements; eastern and western Europe, Mexico, South America and South Korea. Merial, which employs 6,600 people and operates in more than 150 countries, markets pet health brands including Frontline, Heartgard, NexGard and Purevax and Vaxxitek, Eprinex, Ivomec, Longrange, Circovac and GastroGard in farm animal health.

Class action against homeopathic teething marketers

A class action complaint pending in the US District Court for the Southern District of New York accuses Hyland’s,Church & Dwight Co. Inc.,CVS Health Corp. and other marketers and retailers that market or sell homeopathic teething remedies of marketing “useless and unsafe” products, announces Bernstein Liebhard LLP, a New York-based firm. The complaint, filed Nov. 9 and made public Jan. 3, follows FDA’s September alert that warned consumers to stop using homeopathic teething tablets and gels because they may pose a risk to infants and children, based on adverse event reports including seizures in infants and children. The warning prompted CVS to remove homeopathic teething tablets and gels from its store shelves and Hyland’s halted marketing of the products, even though it disputes FDA’s stance and says it is not aware of any data supporting the adverse event claims. (Also see "FTC Homeopathic Disclaimer Policy Should Prompt FDA Changes – Advocacy Group" - Pink Sheet, 21 Nov, 2016.) However, an attorney for from Bernstein Liebhard says the firm “has heard from a number of consumers who believe their children may have been harmed by homeopathic teething remedies.” In November, the Federal Trade Commission published an "Enforcement Policy Statement" that clarifies its existing approach to regulating advertising, including label statements, for homeopathics, but it also advises that the agency expects firms to add disclaimers, including comparatively lengthy statements where needed, to products labeled with a treatment indication. (Also see "OTC Homeopathic Labels Must Include Scientific Disclaimers – FTC" - Pink Sheet, 15 Nov, 2016.)

CBD oil supplier heats up

NutraFuels Inc. struck a working partnership to provide cannabidiol products to BIOS Biochemicals Corp.'s natural health and wellness business LIDTKETechnologies after it fulfilled an order for the Casa Grande, Ariz., firm shortly before Christmas. In a Jan. 4 release, NutraFuels said it will continue to supply the firm with its natural wellness oral ingestible nutritional supplement formulas including CBD Original, CBD with L-Tryptophan and CBD with Turmeric packaged and sold in tincture drop bottles as oral ingestible nutritional supplements. LIDTKE provides rare and high-quality nutrients to medical doctors, naturopaths, veterinarians, and alternative health practitioners. “We value the new business opportunity that has been secured and look forward to a long-lasting fruitful relationship with LIDTKE and their team,” NutraFuels CEO Edgar Ward states in the Coconut Creek, Fla., firm's release.

Health care investment firm closes fund

Health care-focused investment firm CRG, previously known as Capital Royalty L.P., announces final closing of CRG Partners III L.P. at a hard cap of $1.25bn of capital commitments from investors, exceeding its original target by 25%. In a Jan. 4 release, the Houston firm says total investable capital for the fund is expected to approach $2bn. The fund has committed more than $900m of capital across 16 public and private, commercial-stage healthcare investments, since a previous close in March 2015. The firm says the fund has built a diverse portfolio, including investments in the medical device, tool and diagnostic, biopharmaceutical and health care IT and services sectors.