Legal Alerts
AHPA keeps members and the industry informed of recent news and developments that impact the trade through email alerts. Subscribe to news as it happens or a weekly summary of all alerts.
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FDA warns of toxic yellow oleander alleged in multiple tejocote products; recall issued
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FDA warns Lone Star Botanicals for alleged FD&C drug claims, alleged cGMP and labeling violations
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FDA warns multiple companies for alleged unapproved homeopathic eye drops
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Consent decrees entered against Utah dietary supplement manufacturer and distributor
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FDA delays MoCRA facility registration and product listing enforcement to next July
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New York passes weight loss/muscle building supplement age restriction law
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New EU pesticide maximum residue limits to take effect September 14
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Multiple nuez de la India products recalled for containing toxic yellow oleander
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FDA warns Cosmax NBT USA for alleged cGMP and labeling violations
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New EU pesticide maximum residue limits to take effect September 14
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NPA issues citizen petition to FDA regarding dietary supplement labeling of mushrooms and mycelia
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FDA warns Five Leaf Pet Botanicals for alleged FD&C animal drug claims
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FDA warns Eden’s Answers for alleged cGMP and labeling violations
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FDA warns Sunshine Trading Company for alleged FD&C drug claims
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TruVision Health recalls products due to possible health risk
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FDA issues draft guidance on labeling of plant-based milk alternatives
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USDA APHIS announces planned Lacey Act essential oil coverage
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FDA warns Saffron USA LLC for alleged FD&C drug claims (FDA)
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FDA warns Rosebud's Ranch and Garden, LLC for alleged FD&C drug claims (FDA)
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FDA warns The Truth Company, LLC for alleged FD&C drug claims (FDA)
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FDA warns seven companies for alleged FD&C cardio drug claims (FDA)
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District court enjoins Arizona company from distributing adulterated/misbranded dietary supplements (DoJ)
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FDA and FTC send letters to Lakpura LLC for alleged FD&C COVID-19 drug claims (FDA)
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The Chai Box recalls bottled products due to potential contamination (FDA)
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FDA warns Muscle Sports Products, LLC for alleged FD&C drug claims (FDA)
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FDA warns Nutritional Laboratories Int’l for alleged cGMP violations (FDA)
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USDA APHIS to replace import database and manuals with new ACIR database (USDA)
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FDA warns The Elderberry Fairy & Co., LLC for alleged FD&C drug claims (FDA)
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APHIS PPQ to permanently accept electronic phytosanitary certificate copies October 1, 2022 (USDA)
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FDA releases finalized NAC enforcement discretion guidance (FDA)
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FDA warns Muscle Feast, LLC for alleged cGMP violations (FDA)
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BBB direct selling council recommends Root Wellness discontinue claims (BBB)
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FDA supplements proposed ag water rule with new compliance dates (FDA)
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FDA/FTC warn MONQ, LLC for alleged FD&C drug claims (FDA/FTC)
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FDA/FTC warn four kratom companies for alleged FD&C drug claims (FDA/FTC)
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AHPA publishes comparison document for heavy metals standards
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FDA warns 5 companies for alleged CBD and Delta-8 FD&C drug claims
April 2022
March 2022
February 20222
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AHPA article provides context for reduced FDA inspections of dietary supplement facilities
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FDA releases industry guidance on chlorpyrifos residues following tolerance revocation (FDA)
January 2022
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FDA to hold public meetings on proposed agricultural water rule revision (FDA)
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FDA Announces Qualified Health Claims for Magnesium and Reduced Risk of High Blood Pressure (FDA)
December 2021
November 2021
October 2021
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EPA announces trifloxystrobin tolerance petition for new Spice Crop Group (EPA)
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FTC closes NARB referred case regarding Avadim Health, Inc (FTC)
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FDA warns ICA Health, LLC/Future Formulations, LLC for alleged FD&C drug claims (FDA)
September 2021
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FDA warns Fibromyalgia Treatment Group - FTG, LLC for alleged FD&C drug claims (FDA)
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FDA warns McDaniel Water, LLC for alleged FD&C drug claims (FDA)
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FDA warns American Metabolix for alleged FD&C drug claims, product adulteration (FDA)
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EPA announces first IR-4 tolerance petition for new Spice Crop Group (EPA)
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HSA/FSA/RSA supplement legislation introduced in U.S. House (Congress.gov)
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FDA warns Brilliant Enterprises LLC for alleged FD&C drug claims (FDA)
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FDA and FTC warn 10 companies for alleged diabetes FD&C drug claims (FDA)
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Florida man pleads guilty to conspiracy involving illegal products labeled as supplements (DoJ)
August 2021
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Louisiana Constable pleads guilty in federal court on misbranded drug charge (DoJ)
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Recent California Proposition 65 activity includes notices for naturally-occurring chemicals
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EPA to revoke all tolerances, registrations for pesticide Chlorpyrifos
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EPA announces petition for new pesticide tolerance in new herb and spice crop groups (EPA)
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Multiple substances planned for sunset removal from NOSB National List (USDA)
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FDA warns 3RD Day Nutraceuticals, LLC for alleged FD&C drug claims
July 2021
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Senators request multimillion dollar budget increase for ODSP (US Senate)
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USDA APHIS announces Oct 1 date for Lacey Act Phase VI enforcement (Federal Register)
June 2021
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FDA warns JLM Nutritionals, Inc. for alleged FD&C drug claims (FDA)
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FDA warns Fresh Nutrition Inc for alleged FD&C drug and animal drug claims (FDA)
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FDA warns Red's Kitchen Sink at Bourbon Street Ice for alleged FD&C drug claims (FDA)
May 2021
April 2021
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Congress adds sesame to list of major food allergen (Kleinfeld, Kaplan, & Becker)
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AHPA engages California legislature on Prop 65 and weight supplement bills
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FDA warns Maison Terre for alleged FD&C CGMP violations and drug claims
March 2021
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FDA warns two companies for alleged sale of CBD OTC topical products
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New York supplement manufacturer receives permanent injunction for CGMP violations
February 2021
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FDA warns ten companies for alleged FD&C mental health drug claims
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FDA warns Entia Biosciences, Inc for alleged FD&C drug claims
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FDA warns American Global Health Group, LLC for alleged FD&C drug claims
January 2021
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FDA warns Sage Moon Apothecary, LLC for alleged FD&C drug claims
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FDA warns Smarter Nutrition, Inc. for alleged FD&C drug claims
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FDA warns Speedwinds Nutrition, Inc. for alleged FD&C drug claims
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AHPA applauds FDA public warning on alleged misbranded drugs marketed online
December 2020
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Federal guilty plea by SARMS marketer for unapproved new drug distribution
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FDA warns Quten Research Institute, LLC for alleged FD&C violations
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Fusion Health and Vitality LLC issues voluntary nationwide recall
November 2020
October 2020
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Customs and Border Protection asserts certain Chinese stevia extracts produced with prison labor, bars import (Federal Register)
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FDA & FTC warn Tonic Therapeutic Herb Shop & Elixir Bar for alleged COVID-19 claims
September 2020
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FDA Provides Additional Flexibility Regarding Nutrition and Supplement Facts Labels
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FDA & FTC warn Pharmacy Plus, Inc. for alleged COVID-19 claims
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FDA rejects oleandrin as a dietary supplement ingredient (CNN)
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FDA and FTC warn two more companies for alleged COVID-19 claims
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FDA warns Hampshire Labs, Inc. for alleged prostate and lung claims
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FDA warns two companies for claims related to opioid addiction
August 2020
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FDA warns Custom Nutraceuticals for alleged cGMP violations (FDA)
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FDA and FTC warn Living Senior for alleged COVID-19 claims for CBD products
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Resources for food producers in areas affected by storms Laura and Marco (FDA)
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FDA and FTC warn SilveryGuy for alleged COVID-19 claims made for Amazon Associates product
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FDA and FTC warn Canadian Chaga for alleged COVID-19 claims (FDA & FTC)
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FDA warns New Genesis Health for alleged cGMP violations (FDA)
July 2020
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FDA Warns Seven Companies Allegedly Illegally Selling Hangover Remedies (FDA)
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FDA announces qualified health claim for certain cranberry products and urinary tract infections (FDA)
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USDA AMS final guidance on bioengineered food disclosure (Federal Register)
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FDA looks to resume domestic on-site inspections during the week of July 20 (FDA)
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APHIS will continue to accept electronic phytosanitary certificates and forms through Sept. 30 (USDA)
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FDA issues Final Rule on safe use of vitamin D2 mushroom powder as a nutrient supplement (Federal Register)
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FDA and FTC warn three more companies for alleged COVID-19 claims (FDA & FTC)
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FDA warns Washington Homeopathic Products for alleged cGMP violations (FDA)
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FDA and FTC warn seven more companies for alleged COVID-19 claims (FDA)
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FDA warns Only Natural, Inc. for alleged drug claims and labeling violations (FDA)
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FDA and FTC warn three more companies for alleged COVID-19 claims (FDA)
June 2020
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FDA warns BHP Holdings for allegedly failing to review all product complaints (FDA)
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FDA and FTC warn six more companies for alleged COVID-19 claims (FDA)
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FDA and FTC warn two more companies for alleged COVID-19 related claims (FDA)
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FDA warns Morningstar Minerals for alleged cGMP violations and drug claims (FDA)
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FDA warns NutraCap Labs for products allegedly containing DMHA (FDA)
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FDA and FTC warn three more companies for alleged COVID-19-related claims (FDA)
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FDA and FTC warn 7 more companies for alleged COVID-19 claims (FDA)
May 2020
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FDA warns Humaworm for alleged labeling and marketing claims violations
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FTC refunding more than $8.5 million to consumers defrauded by misleading supplement claims
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FDA and FTC warn more companies for alleged unapproved and misbranded products related to COVID-19
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FDA warns Global Vitality for alleged drug claims and cGMP and labeling violations (FDA)
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FDA warns four more companies for promoting drugs, homeopathic products and supplements for COVID-19
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FDA warns Hawaii Pharm LLC for alleged violations of FDA dietary supplement regulations (FDA)
April 2020
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FDA warns Earth Angel Oils for products allegedly promoted for COVID-19 (FDA)
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FDA warns Nova Botanix LTD DBA CanaBD for CBD products allegedly promoted for COVID-19 (FDA)
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FDA warns Herbs of Kedem for products allegedly promoted for COVID-19 (FDA)
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FTC announces 10 warning letters issued over Coronavirus related products (FTC)
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FDA and FTC warn five more companies for alleged COVID-19 claims
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FDA warns 360 Bullet Inc. over unapproved new drugs and adulterated supplements (FDA)
March 2020
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FDA guidance on Adverse Event Reporting During a pandemic (FDA)
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FDA and FTC warn seven companies selling fraudulent products that claim to treat or prevent COVID-19
February 2020
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FDA warns R-Garden LLC for alleged therapeutic claims and cGMP violations (FDA)
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FDA warns Evig LLC for alleged drug claims on website, YouTube channel and product labeling (FDA)
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FDA warns Wave Miami for drug-spiked products masquerading as supplements (FDA Warning Letter)
January 2020
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Sen. Schumer urges HHS probe into alleged adulterated dietary supplements (Sen. Schumer Press Release)
December 2019
November 2019
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FDA warns 15 companies for allegedly selling CBD products that violate the FD&C Act (FDA)
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FDA warns Revital U International for products with DMHA (FDA warning letter)
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FDA withdraws compliance policy guide on homeopathic drug products and issues revised draft guidance (KKB)
October 2019
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FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims
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FDA warns Paisley Farms for alleged drug claims and cGMP, labeling violations(FDA warning letter)
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FDA warns Ibitta Enterprises for alleged cGMP and labeling violations
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FDA warns Herbal Healer Academy for alleged therapeutic claims (FDA Warning Letter)
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FDA warns Alternative Laboratories for products labeled to contain DMHA and CBD (Warning Letter)
September 2019
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FDA warns contract manufacturer Nutra Solutions for alleged cGMP violations (Warning Letter)
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FDA warns Absonutrix, LLC for alleged cGMP and labeling violations (FDA)
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FDA warns Sportron International for alleged cGMP violations related to contract manufacturing (FDA)
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Consent decree entered against drug, dietary supplement and device distributors (FDA)
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FDA modifies processes for NDI and structure/function claim notification submissions (FDA)
August 2019
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FDA warns H & A Walters Fulfillment Center for alleged cGMP violations (FDA)
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FDA warns Let's Talk Health for alleged cGMP violations and drug claims
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First warning letter for failure to develop FSVP (FDA Law Blog)
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FDA warns Premium Production LLC for alleged cGMP violations (FDA Warning Letter)
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FDA warns Perfect Choice Trading, Inc. and Nutricos Ceuticals, Inc. (FDA Warning Letter)
July 2019
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FDA warns Ceba-Tek for alleged cGMP violations (FDA Warning Letter)
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Guidance on using 'natural' claims issued by Australia's Therapeutic Goods Administration (TGA)
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FDA warns KratomNC for kratom products marketed to treat or cure opioid addiction (FDA)
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FDA warning letter to HealthTech International Inc. alleges cGMP and labeling violations (Warning Letter)
June 2019
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FDA warns Cali Botanicals for kratom products marketed to treat or cure opioid addiction (FDA)
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FDA warns SomaLabs for inadequate responses to alleged cGMP violations (FDA)
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FDA warns PRL Inc for alleged cGMP violations and therapeutic claims (Warning Letter)
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FDA Updates FSMA FAQ to Include Questions and Answers on Produce Safety (FDA)
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FDA warns ActiveHerb Technology claims on traditional uses that FDA interprets as drug claims (FDA Warning Letter)
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Forest service announces 2019 ginseng lottery (The Mountaineer)
May 2019
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Complaint Filed Against Company to Stop Distribution of Adulterated Dietary Supplements (DOJ)
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Man receives two-year prison sentence for importing and selling misbranded kratom (US DOJ)
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FDA warns manufacturers of products labeled as homeopathic (FDA)
April 2019
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FDA Launches New Dietary Supplement Ingredient Advisory List
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Geniux Dietary Supplement Sellers Barred from Unsupported Cognitive Improvement Claims (FTC)
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ALERT: Medical Cannabis Research Act Stirs DEA Marijuana Registration Pot (FDA Law Blog)
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FDA public hearing on cannabis product safety, manufacturing, quality, marketing, labeling, and sales (Federal Register)
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FDA warns three CBD companies for online marketing claims (FDA Warning Letter)
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FDA warns four homeopathic firms alleging violations of manufacturing quality standards (FDA Warning Letter)
March 2019
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FDA warns IMedDo for alleged website claims that establish products as drugs (FDA Warning Letter)
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Additional Certification Bodies Accredited Under FDA’s Accredited Third-Party Certification Program (FDA)
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FDA to Hold Public Meeting to Discuss Responsible Innovation in Dietary Supplements (FDA)
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FDA warns Nutra Pharma for alleged drug claims used to market products labeled as homeopathics (FDA Warning Letter)
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FDA warns Hanna's Herb Shop for alleged drug claims (FDA Warning Letter)
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FDA warns Phi Sciences for alleged cGMP violations and drug claims (FDA Warning Letter)
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FDA Commissioner Scott Gottlieb to step down (New Hope)
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FDA warns Green Water, LLC for alleged cGMP violations and drug claims (FDA)
February 2019
January 2019
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Senators ask FDA to update rules on certain hemp products (Associated Press) 01/15/2019
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USDA’s final rule for GMO labeling ignores recommendations of consumers and AHPA 01/08/2019
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Surgeon General calls for marijuana reclassification (Forbes) 01/07/2019
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State proposes regulations on hemp crop (Illinois News Network) 01/06/2019
December 2018
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Nutritional supplements access preserved in Arizona 12/17/2018
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FDA warns DynaPro International for alleged cGMP violations and drug claims (FDA) 12/11/2018
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DynaPro International for alleged cGMP violations and drug claims (FDA) 12/11/2018
November 2018
October 2018
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FDA warns Duy Drugs for products allegedly spiked with drugs (FDA) 10/02.2018
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Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices (FDA) 10/29/2018
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FDA warns Original Living Coconut for marketing food products with drug claims (FDA) 10/31/2018
September 2018
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FDA commissioner issues statement on companies marketing kratom with unproven medical claims (FDA) 9/11/2018
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FDA webinar to help food importers understand VQIP (FDA) 9/13/2018
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FDA warns Best Nutrition Products for alleged cGMP and labeling violations (FDA) 9/18/2018
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FDA warns Celletech for claims that establish products as drugs (FDA) 9/18/2018
August 2018
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FDA warns www.poppyseedwash.com for therapeutic claims (FDA) 8/14/2018
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FDA warns Signature Formulations for marketing CBD products as dietary supplements (FDA) 8/15/2018
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FDA warns Healthy Healing-Crystal Star for drug claims and alleged cGMP violations (FDA) 8/21/2018
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FDA expresses support for exempting coffee from CA Prop 65 cancer warnings (FDA) 8/30/2018
July 2018
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FDA warns GC Natural for alleged cGMP and labeling violations (FDA) 7/31/2018
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European Court rules that gene editing is genetic engineering (BBC News)
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FDA warns Aegle Nutrition for inadequate responses to alleged cGMP and labeling violations (FDA) 7/17/2018
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Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement (FDA) 7/2/2018
July 2018
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FDA warns GC Natural for alleged cGMP and labeling violations (FDA) 7/31/2018
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European Court rules that gene editing is genetic engineering (BBC News)
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FDA warns Aegle Nutrition for inadequate responses to alleged cGMP and labeling violations (FDA) 7/17/2018
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Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement (FDA) 7/2/2018
June 2018
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FDA warns Health Management Group for alleged cGMP and labeling violations (FDA) 6/20/2018
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FDA releases draft guidance for FSMA intentional adulteration rule (FDA) 6/19/2018
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FDA issues guidance, science review, and citizen petition responses on dietary fiber (FDA) 6/18/2018
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FDA warns Dual Health Body and Mind for selling pure caffeine powder (FDA) 6/12/2018
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FDA warns Silver Armor, Inc. for therapeutic claims and alleged cGMP violations (FDA) 6/5/2018
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AHPA recommends oshá harvest permitting in GMUG National Forests 6/5/2018
May 2018
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Ethanol Extraction Recalls Alcohol Product Because of Possible Health Risk (FDA) 5/23/2018
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AHPA represents member interests at USP Dietary Supplement Stakeholder Forum 5/17/2018
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FDA warns Baker's Best Health Products Inc. for website claims and misbranded products (FDA) 5/17/2018
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FDA warns Chi's Enterprise Inc. for multiple alleged cGMP violations (FDA) 5/17/2018
April 2018
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AHPA recommends CBD not be scheduled under any international drug control convention 4/24/2018
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Rate of NDI notifications reported by FDA unexpectedly drops 4/24/2018
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Chuck Schumer To Introduce Bill To Decriminalize Marijuana (NPR) 4/20/2018
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FDA warns Amerigo Labs for alleged online therapeutic claims and labeling violations (FDA) 4/17/2018
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AHPA supports FDA guidance making pure or highly concentrated caffeine dietary supplements unlawful 4/13/2018
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FDA warns Vital Hierbas Naturales Corporation for alleged drug claims and labeling violations (FDA) 4/10/2018
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FDA warns South Texas Botanicals for alleged disease claims and cGMP and labeling violations (FDA) 4/10/2018
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FDA warns Ozark Country Herbs for alleged disease claims and cGMP and labeling violations (FDA) 4/10/2018
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FDA orders mandatory recall for kratom products due to risk of salmonella (FDA) 4/4/2018
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Chinese Citizen Pleads Guilty to Mail Fraud and Smuggling Related to Dietary Supplement Scheme (DOJ) 4/4/2018
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Calif. Judge Rules Coffee Must Come With A Cancer Warning, But Should It? (NPR) 4/3/2018
March 2018
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FDA warns Biotek alleged contract manufacturing cGMP violations (FDA) 3/27/2018
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Trump Signs Omnibus Spending Bill With Boost in FDA Funding (Regulatory Focus) 3/23/2018
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3/14/2018
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FDA warns Minnesota Emu for drug claims and failing to register facility (FDA) 3/14/2018
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FDA warns Carol Bond Health Foods for inadequate responses to alleged cGMP violations (FDA 3/14/2018
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Company recalls kratom products due to potential Salmonella contamination (FDA) 3/13/2018
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FDA releases Guidance on fiber and several other key issues (CFSAN) 3/1/2018
February 2018
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FDA warns Terra Biological for misbranded medical food marketed with online drug claims 2/27/2018
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FDA investigates multistate Salmonella outbreak linked to kratom products (FDA) 2/21/2018
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FDA warns Young Health Products for online drug claims (FDA) 2/13/2018
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FDA warns Long Life Unlimited for disease claims in online testimonials (FDA) 2/13/2018
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FDA warns Reishi D. International for alleged cGMP and labeling violations (FDA) 2/13/2018
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FDA warns Long Life Unlimited for disease claims in online testimonials (FDA) 2/6/2018
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AHPA encourages CFSAN to improve regulations for herbal products 2/5/2018
January 2018
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FDA warns Young Health Products for online drug claims (FDA) 1/31/2018
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FDA issues guidance to help importers and food producers meet FSMA requirements (FDA) - 1/24/2018
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FDA warns USA Labs for online drug claims (FDA) - 1/23/2018
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FDA warns Coenzyme-A Technologies for drug claims (FDA) - 1/23/2018
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FDA warns Innovita for drug claims and inadequate responses to alleged cGMP violations (FDA) - 1/11/2018
December 2017
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FDA warns for Madison One Acme Inc. dba Solstice Medicine Company drug claims and labeling violations (FDA) - 12/20/2017
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FDA warns GnuPharma Corp. for drug claims, labeling violations and alleged cGMP violations (FDA) - 12/20/2017
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FDA warns Professional Botanicals for alleged cGMP and labeling violations and drug claims (FDA) - 12/19/2017
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FDA warns Grandma's Herbs for online drug claims (FDA) - 12/19/2017
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FDA warns Arco Globus Trading for promoting two products as alternatives to street drugs (FDA) - 12/12/2017
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FDA warns Wellness Resources for online drug claims (FDA) - 12/5/2017
November 2017
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FDA Mannatech Incorporated for drug claims, labeling violations and alleged cGMP violations (FDA) - 11/22/2017
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FDA warns Vita Pure for inadequate responses to alleged cGMP violations (FDA) - 11/22/2017
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FDA issues public health advisory on the risks of kratom use - 11/22/2017
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FDA Releases Small Entity Compliance Guide for FSMA Sanitary Transportation Rule (FDA) - 11/21/2017
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FDA warns Hello Life, Inc for products with nutrient levels that don't equal amount listed on label (FDA) - 11/15/2017
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FDA warns Biomin Industries for drug claims and alleged cGMP and labeling violations (FDA) - 11/7/2017
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FDA warns three companies for products containing selective androgen receptor modulators (FDA) - 11/2/2017
FDA warns companies marketing CBD products that claim to treat or cure cancer (FDA) - 11/2/2017
October 2017
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FDA warns Nexagen for alleged cGMP violations (FDA) - 10/31/2017
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Four Chinese Companies indicted in scheme to sell mislabeled dietary supplements (DOJ) - 10/26/2017
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FDA warns Total Body Nutrition for DMAA in several products (FDA) - 10/18/2017
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Supplement maker prohibited from manufacturing products due to alleged cGMP violations (FDA) - 10/16/2017
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FDA and USDA seek input on impacts of agricultural biotechnology (FDA) - 10/12/2017
August 2017
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Three Dietary Supplement Marketers Settle FTC, Maine AG Charges (FTC) - 8/31/2017
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FDA warns Total Nutrition for alleged cGMP violations and drug claims (FDA) - 8/29/2017
September 2017
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FDA warns MusclMasster, LLC for products with ephedra, drug claims and alleged cGMP violations (FDA) - 9/20/2017
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FDA warns Vicare International for inadequate responses to alleged cGMP violations (FDA) - 9/27/2017
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FDA proposes to extend compliance dates for nutrition facts label final rule (FDA) - 9/29/2017
July 2017
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California Publishes Q&A on New Prop 65 Warning Requirements (OEHHA) - 7/12/2017
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FDA warns New Capstone for drug claims in testimonials and on website (FDA) - 7/11/2017
June 2017
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FDA warns Nature's Vision for alleged cGMP and labeling violations (FDA) - 6/27/2017
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FDA warns Xcel Sports Nutrition for Acacia rigidula products and alleged cGMP violations (FDA) - 6/27/2017
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FDA delaying overhaul of nutrition labels (The Hill) - 6/15/2017
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FDA warns Bio TE Medical for alleged cGMP and labeling violations (FDA) - 6/7/2017
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FDA warns Life Rising Corporation for alleged cGMP violations and drug claims (FDA) - 6/6/2017
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FDA warns Herbal Doctor Remedies for drug claims (FDA) - 6/6/2017