FDA Zeroes in on Supplement Makers Over Claims, GMP Problems
The FDA has zeroed in on five dietary supplement makers in recent weeks, complaining of a laundry list of issues that range from promotional claims to GMP problems.
The first letter went to Rocky Fork Formulas after agency officials reviewed claims it made online for 10 of its products and concluded that all of them relied on efficacy claims reserved for prescription drugs, according to a warning letter posted May 24. For example, the company’s Niacin 500 timed-release supplement claimed that it “lowers cholesterol” and can alleviate joint pain, while another product included a drug-like claim right in its name: Arthritis Complex HS.
The company also was accused of adulterating these products based on findings from an inspection last summer at Rocky Fork Formulas’ facility in Westerville, Ohio. The inspector found that the plant lacked sufficient specifications to ensure products had been formulated correctly. And while company officials claimed to have product specifications, they were unable to produce them during the inspection, the letter says.
Unapproved Promotional Claims
Beauty & Health International also was cited for unapproved promotional claims, with an FDA warning letter accusing it of marketing seven supplements using prescription-drug language.
The warning letter included a claim that Dr. Immune H-100’s could speed recovery from “extreme stress and illness like burns, surgery and cancer,” and a claim that Ginseng Gro Oil can “help grow hair fast.”
An accompanying inspection of the company’s Garden Grove, Calif., facility last summer also triggered other FDA complaints. The plant did not have written procedures for quality control operations related to component receiving, packaging and labeling, laboratory work, and holding and distributing.
A third supplement maker, Alabama-based Macular Health, faced similar allegations over claims found on its website.
A warning letter complains that the firm improperly made therapeutic, curative and preventative claims about nine of their products, claims reserved for prescription products.
The letter, which stems from an FDA review of the company’s website in March, contends that these claims elevate the supplements to prescription drug-status, thereby rendering them unapproved new drugs because the company did not seek FDA approval.
The next letter targeted Summit Beverage Group over the company’s failure to follow procedures when dealing with out-of-specification results from in-process testing, among other issues.
Manufacturing Records Issues
The May 2 warning letter also notes problems with the company’s master manufacturing records. For several alternative energy products, the potency listing for ingredients in the master records was blank, as were listings for specification limits.
During the May 2015 inspection that prompted the warning letter, Summit’s regulatory compliance officer said she reviews finished product testing results by verifying that she has a result for each batch. However, “she does not verify that specifications are met because there are no specifications,” the letter says.
The final letter went to Riddhi USA of Ronkonkoma, N.Y., which was cited for four of its supplements.
According to the April 27 letter, the FDA found that the company did not perform identity testing on any dietary ingredient used to manufacture those products.
Another complaint was that Riddhi’s facility lacked written procedures for quality control operations, such as conducting a material review, making a disposition decision, and approving or rejecting products.
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