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Welcome to our monthly digest of litigation and regulatory
highlights impacting the food and beverage industry. As it
has been for many months, the story was mostly about what s
going on in the food court. Let s take a look..
Vanilla, vanilla, and more vanilla..The plaintiff s bar
remains skeptical of any product labeled as vanilla. Among
the many vanilla-related lawsuits filed,
McDonald s,
Whole Foods and
Trader Joe s defended suits alleging that their
vanilla ice cream, vanilla almond milk, and vanilla almond cereal
respectively were falsely labeled as vanilla. However, in a
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Welcome to our monthly roundup of regulatory and litigation
highlights impacting the dietary supplement and personal care
products industries.
NAD tackled substantiation for
#1 Dermatologist Recommended claims in a challenge
involving L Oreal s CeraVe moisturizer and use of
syndicated survey data to support related claims.
Health claim substantiation was front and center in a Council
for Responsible Nutrition-led
challenge involving glutathione and the level of evidence
required to support claims relating to low-glutathione levels.
Indirectly related to dietary supplements and consumer care, the
FTC announced a
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On February 26, 2021, Judge LaShann DeArcy Hall, of the United
States District Court for the Eastern District of New York,
dismissed with prejudice a putative class action asserting claims
under the Securities Exchange Act of 1934 against a pharmaceutical
company and certain of its officers.
In re Alkermes
Public Ltd. Co. Sec. Litig., No. 18-CV-7410 (LDH) (RML), slip
op. (E.D.N.Y. Feb 26, 2021). Plaintiff alleged defendants
made misstatements concerning clinical trials for a drug that
ultimately did not secure FDA approval. The Court held that
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As anticipated, Delta-8 tetrahydrocannabinol ( Delta-8
THC ) has become the hottest, most flourishing cannabinoid
currently found on the U.S. market. In the past few months, the
sales of Delta-8 THC products have exploded, representing the
fastest growing segment of hemp-derived products.
Yet, despite its growing popularity, the legality of Delta-8
THC, including that of Delta-8 THC products, remains murky. This
blog post provides a broad, 30,000-foot view on this issue.
Federal Legal Framework
Delta-8 THC
Although all hemp-derived cannabinoids, including hemp-derived
Delta-8 THC, seem to fall squarely within the definition of hemp
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On March 3, 2021, FDA issued a statement acknowledging that certain
entities produce certificates of registration for medical device
manufacturers and clarifying that the agency does not issue such
certificates. The agency also announced that it sent letters to 25
entities demanding that they stop producing these false and
misleading certificates because some device manufacturers and
distributors are using them to claim that the devices they produce
or sell are cleared, approved, or otherwise authorized by FDA. It
is important to add that FDA likewise does not issue certificates