A proposed class action alleges Lactaid is misleadingly labeled and advertised with claims that the dietary supplement can prevent, treat, cure or mitigate lactose intolerance and/or symptoms of the condition.
The 13-page lawsuit alleges Johnson & Johnson Consumer subsidiary McNeil Nutritionals has violated the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA regulations by labeling the following Lactaid supplements in a manner that misrepresents that the products are effective to diagnose, prevent, treat, cure or mitigate lactose intolerance and/or characteristic symptoms associated with being lactose intolerant, such as gas, bloating and diarrhea:
Lactaid Fast Act Chewables;
Lactaid Fact Act Caplets; and
Lactaid Original Strength Caplets.
According to the suit, the FDCA stipulates that a statement on a dietary supplement’s label may not claim that the product can diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases. Moreover, a supplement label is considered misleading, and a product therefore misbranded, if it omits information that is “material in light of the claims made for the product or the consequences that may result from using the product,” the complaint says.
Overall, the FDCA prohibits all health claims on food and dietary supplement labels except those that the FDA has expressly authorized by regulation, the case relays.
The filing contends that by claiming the above Lactaid supplements can both prevent gas, bloating and diarrhea associated with digesting dairy and make dairy easier to digest, J&J Consumer and McNeil are “holding the Supplements out as drugs.” Drugs, however, are required by the FDA to be labeled with certain disclosures that might be important to consumers, the case stresses.
“Unlike approved drugs, however, the Supplements have not received the requisite FDA approval as being safe and effective for their advertised purpose, and thus do not include the attendant ‘Drug Facts’ information the FDA deems material to consumers,” the lawsuit says. “This end-run around the FDCA’s certification requirement makes the Disease Claims illegal drug claims and the use of these claims to market and promote the Supplements amounts to ‘Health Fraud,’ as defined by the FDA.”
The lawsuit looks to represent all consumers nationwide who bought any of the above-listed Lactaid supplements and are from states with a consumer protection statute substantially similar to the Massachusetts Consumer Protection Act.
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