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Regulatory Compliance
Newsletter 2022 V17

In the News

FDA Warns 11 Companies for Alleged Adulteration

FDA has announced warning letters to 11 companies for products that allegedly included unapproved new dietary ingredients and/or unsafe food additives.  The dietary supplements sold by the11 companies contain one or more of the following ingredients: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine. The agency has previously expressed concern about several of these ingredients for reasons including, for example, the potential adverse effects of higenamine on the cardiovascular system.  Read more

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products.  Read more

FDA Issues New Draft Guidance on Lead in Juice

FDA has taken steps to limit lead in single-strength (not from concentrate or reconstituted with water) apple juice, and other single-strength juices and juice blends. On April 27, 2022, FDA issued draft action levels for recommended limits of lead in juice. The Action Levels for Lead in Juice: Draft Guidance for Industry provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including blends containing apple juice.  Read more

FDA Reiterates That ‘FDA Approved’ Is A Bogus Phrase in Most Cases

The US Food and Drug Administration has issued a document reminding consumers that in only a few cases is ‘FDA approved’ a factual statement.  Read more

FTC Refunding $149 Million to Distributors Victimized in Advocare Scheme

The Federal Trade Commission is returning $149 million to consumers who lost money acting as distributors for Advocare, a former multi-level marketing company deemed by regulators to have been an illegal pyramid scheme.   Read more

Federal Program May Suspend Exports of Fish Oil Supplements

The Seafood Inspection Program (SIP), a division of the National Atmospheric and Oceanographic Administration (NOAA), is planning to suspend export licenses for encapsulated fish oils.   Read more

Class Action Lawsuits VS Food and Bev Brands Surged in 2021

Food & beverage class actions surged in 2021, driven in part by a tsunami of cases over heavy metals in baby food, but judges are wearying of cases that assume consumers have zero common sense, according to a review by law firm Perkins Coie.  Read more

NAD  Finds Innovix Pharma Qualified Claims Supported; Recommends Certain OmegaVia Performance Claims be Discontinued

The National Advertising Division (NAD) determined that Innovix Pharma, manufacturer of OmegaVia Fish Oil and OmegaVia EPA dietary supplements, can make qualified claims about EPA and DHA supplementation to support heart health in addition to a healthy diet and exercise, but should discontinue the challenged product performance claims and testimonials relating to heart health and triglyceride management. The claims at issue were challenged by Amarin Pharma, Inc., the manufacturer of the FDA-approved cardiovascular drug Vascepa.   Read more

FSMA Basics Not So Basic for Food Brands – Podcast

FSMA swept in much-needed food safety regulations for U.S. brands, but many companies continue to struggle with foreign import requirements.  In this podcast, Rae Martin, president of Continuum Partner Consulting interviewed by Sandy Almendarez, editor in chief at Natural Product Insider®  discussed:

  • The most common requirement of FSMA that food brands fail to achieve.

  • The essential component that brands need to achieve FSMA compliance.

  • The one thing Martin would change to FSMA if she could

Learn more.