Tracking Federal Agencies’ Enforcement In Supplement Space

““The Tan Sheet” provides links to previous articles on many of the enforcements DoJ announced from its year-long sweep.

The Department of Justice, FDA and other federal agencies on Nov. 17 announced 40 criminal and civil actions, dating from November 2014, against firms marketing noncompliant products labeled as dietary supplements.

DoJ’s “centerpiece” case is an indictment on 11 criminal charges against [USPlabs LLC], a contract manufacturer that made some of its products, S.K. Laboratories Inc., and executives with the firms .

In addition to charges of drug-spiked products and unsubstantiated claims, the cases include prosecutions on allegations of supplement good manufacturing practices problems, counterfeit product marketing and violations of business or trade regulations. Below are links to other complaints DoJ and the Federal Trade Commission filed recently as part of the sweep.

DoJ Complaints / US District Court	Allegations
United States v. Clifford Woods LLC / Central District of California	Sold Taheebo Life Tea, Life Glow Plus, Germanium and Organic Sulfur (identified as methyl sulfonyl methane) as treatments for various diseases including Alzheimer’s disease and cancer. The complaint alleges that the defendants’ conduct defrauded consumers through the sale of unapproved new and misbranded drugs.
United States v. James R. Hill, doing business as Viruxo / Middle District of Florida	Sold a dietary supplement called Viruxo as a treatment for herpes. The complaint alleges that the defendants’ conduct defrauded consumers through the sale of unapproved new and misbranded drugs.
United States v. Lehan Enterprises Inc. / District of Massachusetts	Sold products called DMSO Cream, DMSO Cream with Aloe and DMSO Roll On as treatments for conditions and diseases including arthritis and cancer. The complaint alleges that defendants sold unapproved new and misbranded drugs.
United States v. Bethel Nutritional Consulting / District of New Jersey	Distribute dietary supplements in a manner that does not conform to current good manufacturing practice for dietary supplements and that they are making claims about the uses for many of the products that render them unapproved and misbranded drugs. Furthermore, FDA testing has revealed that some of defendants’ products contain active pharmaceutical ingredients that are not listed on the products’ labels, including one ingredient that was withdrawn from the market in 2010 because of safety concerns.
United States v. VivaCeuticals, Inc., / Central District of California	Supplements sold by the defendants are adulterated because they are not manufactured in accordance with the FDA’s current good manufacturing practice regulations. One of the dietary supplements, a product called RegeneSlim Appetite Control (RegeneSlim), contains the ingredient 1, 3 dimethylamylamine (DMAA), an unsafe food additive under the federal Food, Drug and Cosmetic Act, but does not declare DMAA as an ingredient. In addition, the defendants market RegeneSlim to be used as a disease cure.
FTC Complaints / US District Court	Allegations
FTC v. Sunrise Nutraceuticals LLC / Southern District of Florida	Sunrise deceptively claims that its dietary supplement Elimidrol, a “proprietary blend” of herbs and other compounds, alleviates opiate withdrawal symptoms and increases a user’s likelihood of overcoming opiate addiction. The FTC’s complaint alleges, however, that Sunrise’s ads for Elimidrol are deceptive because they are false or unsubstantiated.
FTC v. Health Nutrition Products / District of Nevada	Making false and misleading health and efficacy claims in direct mail ads and on a website for W8-B-Gone, CITRI-SLIM 4 and Quick & Easy diet pills. Citing fake scientific studies, the defendants deceptively claimed to have clinical proof that consumers would experience a “RAPID FAT meltdown diet program” that lets them shed five pounds in four days with one pill, or up to 20 pounds in 16 days with four pills. The proposed court orders announced today will settle the FTC’s charges against three defendants involved in the scheme.

“The Tan Sheet” previously has reported on many of the enforcements DoJ announced. Below are links to those articles, with summaries of the information.

Story / Date	Summary
(Also see "Industry Roundup: GNC, Sanofi And Bayer Earnings, 'Miracle Supplement' Fraud Conviction" - Pink Sheet, 2 Nov, 2015.)	The operator of Project GreenLife is sentenced to 51 months in prison for convictions on federal charges stemming from selling industrial bleach labeled as “Miracle Mineral Supplement" to treat cancer, AIDS, malaria, hepatitis, Lyme disease and other conditions.
(Also see "Sunset Natural Injunction Continues Rise In DoJ Supplement GMP Complaints" - Pink Sheet, 5 Oct, 2015.)	Proponents of increasing DoJ enforcement against supplement GMP violators and other bad actors could see 2015 as a banner year as a Sept. 25 injunction against a Florida firm exceeds the total for 2014. Sunset Natural Products Inc. enters a consent decree of permanent injunction that requires it to cease all operations and to receive FDA clearance on GMP compliance before resuming manufacturing and distributing supplements, DoJ announced.
(Also see "Industry Roundup: Children’s Motrin Trial Verdict, Gag’s Up For Roca Labs" - Pink Sheet, 30 Sep, 2015.)	Two firms not only marketed weight loss supplements with unsubstantiated claims, but also threatened “gag clause” litigation against consumers who complained about the products online, the Federal Trade Commission says. A US district court approved a temporary restraining order against Roca Labs Inc. and Roca Labs Nutraceutical USA Inc.
(Also see "Enforcement Roundup: Daniel Chapter One, Peanut Corp. Of America" - Pink Sheet, 28 Sep, 2015.)	James Feijo, owner and operator of Daniel Chapter One, a dietary supplement marketer that incurred FDA and the Federal Trade Commission enforcement, faces a potential prison sentence after pleading guilty to failing to pay more than $218,000 in employment taxes to the Internal Revenue Service.
(Also see "Industry Roundup: Prison For Raw Deal Owner, NIH Funds Botanical Research" - Pink Sheet, 10 Sep, 2015.)	Barry Steinlight, owner and president of Raw Deal Inc., receives a 40-month prison sentence after pleading guilty to a charge of conspiring to commit wire fraud stemming from sales of diluted and adulterated dietary supplements and ingredients.
(Also see "Industry Roundup: J&J Trims Splenda, Hearthside Boosts Capacity" - Pink Sheet, 31 Aug, 2015.)	NourishLife LLC fails to disclose material connections with endorsers of its Speak dietary supplements and made unsubstantiated claims that the product treated childhood speech disorders, including those associated with autism, according to a settlement of an FTC complaint. FTC says the Lake Forest, Ill., firm since 2008 sold Speak softgels and capsules and Speak Smooth liquid children’s supplements online and through distributors for more than $70 per bottle.
(Also see "Industry Roundup: SEC Fines MJN, Criminal Charge For Herbals Seller, Decree Closes Aspen Supplement Marketer" - Pink Sheet, 29 Jul, 2015.)	A Montana herbal supplement seller faces a criminal contempt charge as the Department of Justice alleges the online retailer continued to sell products with claims of curing diseases despite court orders to stop in 2010 and 2013.
(Also see "Industry Roundup: FTC Enforcement, Herbalife Manufacturing, Swanson Health ‘Facts’" - Pink Sheet, 13 Jul, 2015.)	The marketers of Procera AVH dietary supplement agree to pay $1.4m to satisfy a $152m judgment in litigation over unsubstantiated claims the product is clinically proven to “significantly” improve memory.
(Also see "Industry Roundup: FTC, FDA Enforcement, Soft Chew, Bulu Mining" - Pink Sheet, 19 May, 2015.)	Two firms that claimed their dietary supplements could prevent or reverse gray hair settle FTC charges of unfounded claims while a third firm, referred to the agency in industry self-regulation, is targeted for making similar claims.
(Also see "Industry Roundup: Mannatech, FTC On Lunada, Nutroganics, Vitamin Shoppe" - Pink Sheet, 18 May, 2015.)	Lunada Biomedical Inc. sold almost $65mof its Amberen dietary supplement between 2010 and 2013 based on what FTC alleges were false claims of substantial weight loss for women over 40 and that the product is clinically proven.
(Also see "Industry Roundup: Fake News Sites For Weight Loss Products, Spiked Imports, Another DMBA Warning" - Pink Sheet, 11 May, 2015.)	Marketers of false weight loss claims using pitches including fake news content were absent from FTC enforcement for several years before the agency recently shut down another one, which also is alleged to have used unauthorized endorsements from celebrities.
(Also see "Industry Roundup: FDA Investigation Prompts Criminal Charges Against Supplement Marketer" - Pink Sheet, 20 Apr, 2015.)	The operator of Floyd Nutrition LLC in Harrisburg, Pa., enters a plea agreement with DoJ following an FDA investigation that determined the firm imported drug-spiked products marketed as weight loss supplements. FTC issues a final order to bar Health Discovery Corp. from making deceptive or unsupported claims that its MelApp application can help diagnose or assess consumers' melanoma risk.
(Also see "A Day In FDA Supplement Industry Regulation: Track Spiked Product, Oversee Court-Ordered Recall" - Pink Sheet, 14 Apr, 2015.)	FDA identifies a product marketed as a supplement but labeled as containing anabolic steroids and linked to three adverse event reports about “serious liver injury,” and also notes the recall of nearly 150 supplements by a firm shut down in a consent decree made after repeated GMP violations.
(Also see "Missing CAPA Costs J&J $25 Million In Investigation Sparked By OTC Recalls" - Pink Sheet, 11 Mar, 2015.)	Add $25m to Johnson & Johnson’s tab for re-starting manufacturing at its consumer business headquarters as McNeil Consumer Healthcare pleads guilty to a charge linked to failing to have a Corrective Action Preventive Action.
(Also see "Industry Roundup: Nexafed With Acetaminophen; Spiked Supplement Reluctant Recall; Drug Claim Warning; Court Quiets Cole Inc. First Amendment Defense" - Pink Sheet, 5 Feb, 2015.)	James G. Cole Inc.’s bid to claim First Amendment protection for disease claims made in customer testimonials for its Maxam Nutraceutics fails. A federal judge orders a permanent injunction until the Hood River, Ore., firm is compliant with FDA regulations.
(Also see "FTC Members Spar Over ‘Protected’ Speech On ‘Dr. Oz’ In Supplement Claims Enforcement" - Pink Sheet, 27 Jan, 2015.)	FTC announces a settlement including $9min consumer redress for false ads for green coffee extract supplements. In a dissent, Commissioners Maureen Ohlhausen and Joshua Wright argue that comments made in TV programs are “protected non-commercial speech” and should not influence the amount of a fine.
(Also see "RCT Spells Requirement For Lipidryl, Shrinking Beauty Weight Loss Claims" - Pink Sheet, 5 Jan, 2015.)	Add the marketers of Lipidryl and Shrinking Beauty weight loss products to the list of firms FTC is requiring to support future consumer health care claims with at least two randomized clinical trials. Although FTC orders for RCTs to substantiate claims are criticized by some industry stakeholders, the agency routinely includes the burden of clinical trials in settlements with firms found to conduct false and misleading advertising for consumer health products, particularly in the weight loss area.
(Also see "Consent Decree ‘Unnecessary’ But Still Scilabs Nutraceuticals’ High Road For GMP Compliance" - Pink Sheet, 22 Dec, 2014.)	SciLabs Nutraceuticals agrees to a decree that closes its manufacturing operations despite the agency not responding to “numerous requests” to work with the firm on its GMP compliance, says CEO Paul Edalat. Another firm, Raw Deal, also agreed to an offer from FDA and DoJ, but its owner faces incarceration
(Also see "Homeopathic Claims Have FTC Searching For Remedy To Regulatory Conflict With FDA" - Pink Sheet, 15 Dec, 2014.)	FTC shuts down the second marketer of 2014 for making fraudulent claims for human chorionic gonadotropin weight-loss products. Enforcing against other homeopathics’ claims that violate advertising regulations, however, is on hold until FTC resolves its differences with FDA’s regulatory oversight of the products. Utah businessman Kevin Wright agreed to pay $1 million to settle charges that weight loss claims for products marketed by his firms, HCG Platinum LLC and Right Way Nutrition LLC, were deceptive and not supported by scientific evidence.
(Also see "Weight Loss Claims Land Firms On FTC Radar In First ‘Negative Option’ Case" - Pink Sheet, 21 Oct, 2014.)	FTC says Health Formulas LLC of Las Vegas, and its associated firms in Nevada and California, make unsubstantiated claims for green coffee bean extract and other supplement products. A judge issued a temporary injunction against the firms from using “free” trial offers and deceptive health claims.
(Also see "Industry News Roundup" - Pink Sheet, 27 Oct, 2014.)	FDA warns Bethel Nutritional Consulting Inc. about drug claims posted online for its dietary supplements after the firm failed to fix problems the agency pointed out in June 2013.
(Also see "In Brief: Prestige And Vitamin Shoppe Earnings, Lil’ Drug Store Owns Legatrin P.M., FDA Enforcement, DMAA Recall" - Pink Sheet, 11 Aug, 2014.)	FDA continues to find products containing DMAA – the popular pre-workout and weight loss ingredient that the agency says is dangerous and an unapproved new dietary ingredient.
(Also see "Safety Problem Plus GMP Warnings Equal Increased Likelihood Of DoJ Action" - Pink Sheet, 14 Jul, 2014.)	Triceuticals agrees with DoJ to a consent decree of permanent injunction against distributing adulterated supplements. DoJ says a consumer of a Triceuticals product experienced headache, confusion and kidney failure resulting in hospitalization due to vitamin D toxicity.
(Also see "Venus Consent Decree Shows Cost Of Flouting GMP Warning" - Pink Sheet, 29 Oct, 2012.)	Venus Pharmaceuticals International agrees to stop production and distribution of supplements in the U.S. and internationally, and to recall and destroy affected product made prior to January 2012 due to repeated violations of GMP regulations that brought the firm a warning letter from FDA in May.
(Also see "Regulatory News In Brief" - Pink Sheet, 5 Nov, 2012.)	FDA says several products marketed as dietary supplements by Global Source Management & Consulting are unapproved new drugs because they make disease treatment claims.
(Also see "Consent Decrees Are Last “Dance” For Supplement GMP Violators" - Pink Sheet, 26 Nov, 2012.)	Operating under a consent decree is a “dance with the devil,” but it is the last chance for dietary supplement manufacturers to stay in business if they fail to satisfy FDA about compliance with good manufacturing practices, according to food and drug attorney Tony Young.
(Also see "FDA Expects STD Claims Enforcement To Deter Future Violations" - Pink Sheet, 9 May, 2011.)	FDA will consider prosecuting executives of firms making unapproved sexually transmitted disease treatment claims for OTC drugs and nutritional products, the targets of its latest enforcement sweep.