Dietary Supplement Manufacturing & Marketing Lessons
Learn from others’ mistakes
Dietary supplement manufacturing and marketing issues are all cited in this warning letter. This feels like a trip way back in time when GMP regulations and compliance for “supplements” were likely not top of mind. Here’s what we can learn.
GMP compliance: One of the many violations in this letter involves the Batch Production Record (BPR). Although these are fundamental aspects of GMP compliance, re-reviewing these glaring oversights is always a good reminder.
Here are some of the issues FDA pointed out.
- Missing batch, lot, or control number. This is how the product is categorized and tracked.
- Missing the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records, such as individual equipment logs, where this information is retained. This proves that cleaning has occurred and is especially important when reviewing product quality investigations, such as verifying whether major allergen cleaning was conducted.
- Missing identity and weight or measure of each component used.
- Missing statement of the actual yield and a statement of the percentage of theoretical yield at appropriate processing phases. This is one way the formulations are verified to ensure ingredients were not missed or double-counted and that bottles have the correct weight.
- Missing initials of the person responsible for verifying the weight or measure of each component used in the batch. This is the doer and checker system to ensure weights are added correctly and then verified by another party.
- Missing actual or representative label or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record. This is important to prevent labeling mix-ups, which can be very dangerous.
- Missing documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution. Quality must review and release/reject the batch without exception.
Marketing claims: This warning letter contains some of the most severe disease claims I’ve read in a long time. The claims appear on website product pages and actual labels.
From warning letter: “Recommended Package: Cancer . . . This package contains the following products. . Calcium 2 OZ Bottle . . . Magnesium 2 OZ Bottle . . . Silver 2 OZ Bottle”
From warning letter: “On the product label for Silver, 8oz: – “Silver is a potent natural antibacterial, antiviral, and antifungal.”
Sadly, the website remains filled with disease claims and non-compliant product labels. Read the full letter here.
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