February 12, 2019

Federal Register

Risk Management Agency

Notices

Meetings:

2018 Farm Bill Implementation Listening Session

Filed on: 02/11/2019 at 4:15 pm Scheduled Pub. Date: 02/14/2019

FR Document: 2019-02360 PDF 18 Pages (319 KB) Permalink

FDA

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

FTC and FDA Send Warning Letters to Companies Selling Dietary Supplements Claiming to Treat Alzheimer’s Disease and Remediate or Cure Other Serious Illnesses Such as Parkinson’s, Heart Disease, and Cancer

Recalls

Date Brand Product Description Reason/Problem Company

02/08/2019 WTRMLN WTR

Cold pressed juiced watermelon potential presence of soft plastic World Waters, LLC

Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date

02/05/2019 Pure Nootropics, LLC

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 TEK Naturals

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 John Gray’s Mars Venus LLC

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Nutrition Coalition Inc

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Blue Ridge Silver

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Sovereign Laboratories, LLC

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 DK Vitamins

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Peak Nootropics LLC (aka Advanced Nootropics)

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Gold Crown Natural Products

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Emmbros Overseas Lifestyle PVT LTD.

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Earth Turns, LLC

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

02/05/2019 Capris Associates Inc. / BR Naturals

Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

USDA

USDA to Release Complete Set of Tables for Agricultural Projections to 2028

FSIS

Recalls

Product Recalled Date of Recall

015-2019 Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation

Feb 11, 2019

AMS

USDA Dairy Product Purchase Program Announced

USDA Seeks Nominees for United Sorghum Checkoff Program Board

USDA Seeks Nominees for the National Peanut Board

USDA Seeks Nominees for the Highbush Blueberry Council

FTC

FTC Returns Almost $3.5 Million to Consumers Who Bought Deceptively Marketed “Weight-Loss” Supplements from Direct Alternatives and Original Organics, LLC

@SGottliebFDA

• We’re committed to helping beneficial products and innovation advance in the dietary supplement space; but to protect consumers from a small number of bad actors in this burgeoning industry, we need to modernize our framework for overseeing these products: www.washingtonpost.com

• THREAD: Today, the #FDA announced a new plan for implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years. At the same time, we executed a major enforcement action to protect consumers: https://go.usa.gov/xEnDj

• My goal is to achieve the right balance between preserving consumers’ access to lawful supplements, while upholding our solemn obligation to protect the public from unsafe/unlawful products. Today’s announcement reflects new steps by FDA to achieve these twin goals

• Among FDA’s new steps, we will be communicating to the public as soon as possible when there’s a concern about a dietary supplement. Our new rapid-response tool will tell consumers to avoid buying or using suspect products, and notify industry to avoid making/selling them.

• We’ll also need to ensure that our regulatory framework is flexible enough to adequately evaluate product safety while promoting innovation. The key to this effort will be important new steps to foster the submission of new dietary ingredient notifications

• Today, #FDA also issued warning and advisory letters to 17 companies illegally selling products claiming to cure Alzheimer’s. We partnered with the #FTC on three letters and we’ll working to end the violative practices we cited: https://go.usa.gov/xEnDZ

• We’ll hold a public meeting this spring on new steps we can consider to help advance responsible innovation in the dietary supplement industry. We’ll address challenges that may be barriers to innovation, including incentives like exclusivity as a way to promote safe innovation

• [*retweet @jonathanrockoff*] 17 dietary supplement makers are getting letters from @US_FDA alleging they are illegally selling products for Alzheimer’s and other diseases with improper claims, @JaredSHopkins reports https://www.wsj.com/

• FDA finalizes guidance to strengthen its recall processes https://www.medtechdive.com

@FrankYiannasFDA

• THREAD: Since the Dietary Supplement Health and Education Act (DSHEA) was created over 25 years ago, the dietary supplement industry has evolved in more ways than imagined. And with those changes, #FDA’s policies, regulations and enforcements must change as well.

• Today, @SGottliebFDA announced new plans that #FDA will be rolling out soon to address how we plan to take DSHEA into the 21st century with new efforts that will keep the American public safe from dishonest supplement claims: https://go.usa.gov/xEnDj

• #FDA’s new efforts focus on communicating to the public as soon as possible when there is a concern about a dietary supplement & ensuring our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation.

• We’ll also continue working closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

• As part of these efforts, today #FDA also warned consumers to watch out for products falsely claiming to cure Alzheimer’s disease and other, serious conditions. We’ll continue to take such actions to protect public health: https://go.usa.gov/xEnDZ

• [*retweet @Zlatimeyer] Your dietary supplements are about to get safer, as FDA does first overhaul in 25+ years https://www.usatoday.com/story/money/2019/02/11/dietary-supplements-grow-safer-first-fda-overhaul-25-years/2835763002/ … via @usatodaymoney

• [*retweet @NYTHealth*] The F.D.A. warns dietary supplement sellers to stop claiming their powders and pills can cure Alzheimer's and other diseases. It wants Congress to toughen current laws to regulate the booming industry.https://www.nytimes.com/

@FDASpox

• 3 in 4 American consumers take a dietary supplement, spending $40 billion annually on those products. Today, #FDA is announcing new & reformed efforts to strengthen regulation of dietary supplements to protect the public from unsafe products: https://go.usa.gov/xEnDj

• As part of our efforts, today #FDA also warned 17 companies for products falsely claiming to cure Alzheimer’s disease & other serious diseases/health conditions, including diabetes & cancer. We’ll continue working to end this practice: https://go.usa.gov/xEnDZ

@FDArecalls

• World Waters Issues Voluntary Recall of Select WTRMLN WTR Original 12 Packs Due To The Possible Presence of Soft Plastic Pieces. Company Urges Consumers to Check Packages Prior to Consumption http://dlvr.it/QygPqn

@US_FDA

• FDA posted 12 #warningletters & 3 #advisoryletters to companies illegally selling products making unproven drug claims to prevent, treat/cure #Alzheimers disease. Products are marketed & sold online & on social media without FDA approval. #healthfraud https://go.usa.gov/xEnB5

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